Operating Manual Control-And Evaluation Software For Autobio and

Operating Manual
AUTOsoft
AUTOsOFT
Control- and evaluation software
for Autobio LUMO and PHOMO
Software Version 2.6.9, Build 160608
Document ID M S01 100 E
Document Version 2.8
Publishing Date 2016-09-20
Autobio Labtec Instruments

Operating Manual
AUTOsOFT
This manual covers the installation and use of the control and evaluation program
AUTOsoft in the version mentioned on the cover page of this manual and higher. The
manual in it's corresponding current version is supplied as PDF-document on the
installation CD of AUTOsoft.
To verify the version of AUTOsoft installed on your computer please click Help | About in
the main menu of AUTOsoft.
Contact
If you have any questions related to AUTOsoft, please contact us by email with a short
description of your question to the address below. Any suggestions for improvements to
our products and services are welcome.
Autobio Labtec Instruments Co., Ltd.
No.199 15th Ave, National Eco & Tech Zone, Zhengzhou, Henan, China 450016
e-mail: info@autobio-diagnostics.com
phone: +86 371 6798 5313
fax : +86 371 6798 5804
homepage: www.autobio.com.cn
Operating Manual
1. Introduction AUTOsOFT
Manual Warranty Disclaimer
Except as provided in writing signed by an officer to The Manufacturer, this system and
any related documentation are provided "as is" without warranty of any kind, expressed
or implied, including that the system is "error free". This information is presented in good
faith, but The Manufacturer does not warrant, guarantee, or make any representations
regarding the use or the results of the use of this system and related documentation in
terms of correctness, accuracy, reliability, currentness, omissions, or otherwise. The entire
risk as to the use, results and performance of this system and related documentation is
assumed by the user.
Except as expressly provided herein, The Manufacturer makes no other warranty, whether
oral or written, expressed or implied, as to any matter whatsoever, including but not
limited to those concerning merchantability and fitness for a particular purpose, nor is
freedom from any patent owned by The Manufacturer or by others to be inferred.
Limitation of liability
The Manufacturer shall not be liable, to any extent whatsoever, for any damages
resulting from or arising out of the use or performance of this system and related
documentation or the procedures specified in this manual, regardless of foreseeability or
the form of action, whether in contract, tort (including negligence), breach of warranty,
strict liability or otherwise, and including but not limited to damages resulting from loss
of data, loss of anticipated profits, or any special, indirect, incidental or consequential
damages.
In no event shall The Manufacturers liability to the user exceed the amount paid by the
user to The Manufacturer hereunder. The user assumes full responsibility for the results
obtained from the use of this system and related documentation and for application of
such results.
Trademarks
Microsoft, Windows, and Windows NT are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries. IBM is a trademark of
International Business Machines Corporation in the United States, other countries, or
both. Pentium is a registered trademark of Intel Corporation. Adobe, Acrobat, and
Postscript are either registered trademarks or trademarks of Adobe Systems Incorporated
in the United States and/or other countries. All other trademarks appearing in this
manual are owned by their respective companies.
Copyright
Copyright by Autobio Labtec Instruments. All rights reserved. No part of this publication
may be reproduced, distributed, or transmitted in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, or stored in a database or retrieval
system, without the prior written permission of Autobio Labtec Instruments.
© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft I

Operating Manual
AUTOsOFT
Table of contents
1 Introduction .......................................................................................1
2 Installation, Launch, Initial Setup .......................................................3
2.1 Installing AUTOsoft .........................................................................................................................3
2.1.1 System Requirements ...............................................................................................................3
2.1.2 Special requirements for Widows Vista ....................................................................................3
2.1.3 Running the Setup Program .....................................................................................................4
2.2 Installation of USB-driver (optional) ................................................................................................5
2.3 Running the Autobio Software .......................................................................................................7
2.4 Error logging ..................................................................................................................................7
2.5 Initial setup of AUTOsoft.................................................................................................................7
2.6 Configuring Options .....................................................................................................................10
2.6.1 Data Export ............................................................................................................................10
2.6.2 Item Classification ..................................................................................................................11
2.6.3 Others ....................................................................................................................................12
2.6.4 Sample Info ...........................................................................................................................14
2.7 Configuring the Instrument ..........................................................................................................14
2.8 Directory .......................................................................................................................................17
3 Main Screen ..................................................................................... 22

3.1.1 Main Window ........................................................................................................................22
3.1.2 Menu Bar ...............................................................................................................................22
3.1.3 Toolbar ..................................................................................................................................24
4 Defining Test- and Layout ................................................................ 26

4.1 Test Definition ..............................................................................................................................26
4.1.1 Test Definition | General ........................................................................................................27
4.1.2 Test Definition | Quantitative ................................................................................................31
4.1.3 Test Definition | Qualitative ...................................................................................................33
4.1.4 Test Definition | Validation ....................................................................................................35
4.1.5 Test Definition | Shaking .......................................................................................................37
4.1.6 Test Definition | Reference ....................................................................................................38
4.1.7 Test Definition | Advanced ....................................................................................................38
4.1.7.1 Titer Test ...............................................................................................................................39
4.1.7.2 Scan Mode ............................................................................................................................42
4.1.7.3 Using an External Calculation File ..........................................................................................42
4.1.7.4 Variables................................................................................................................................47
4.2 Layout Definition ..........................................................................................................................47
4.3 Multitest .......................................................................................................................................52
5 Run a Test ........................................................................................ 56

5.1 Test Parameter –tab ......................................................................................................................57
5.2 Sample IDs – tab ...........................................................................................................................58
5.3 Results – tab .................................................................................................................................64
5.4 Run test with a saved standard curve ...........................................................................................67
5.5 Save Results ..................................................................................................................................69
5.6 Run a Multitest .............................................................................................................................71
6 Saved Plates and Samples ................................................................ 74
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6.1 Samples ........................................................................................................................................74
6.2 Open Saved Plates ........................................................................................................................81
7 Tools ................................................................................................ 85
7.1 Internal QC ...................................................................................................................................85
7.1.1 Define QC Sera (Data | QC Serum) .........................................................................................87
7.1.2 Define QC Project (Data | View Project) .................................................................................88
7.1.3 View and add QC Data (Data | QC Data) ...............................................................................90
7.1.4 Signing (Setting | Signing) ....................................................................................................93
7.1.5 Print (Setting | Print) .............................................................................................................93
7.1.6 Initialize QC Data (Setting | Initialize QC Data) ......................................................................95
7.2 Export Data ...................................................................................................................................95
7.3 Backup/Restore Database ..............................................................................................................97
7.4 Repair Database ............................................................................................................................98
7.5 Compress Database ......................................................................................................................98
7.6 Initialize Database.........................................................................................................................98
7.7 Log Viewer....................................................................................................................................99
8 Measurements without evaluation ................................................. 101

8.1 Quick Test ...................................................................................................................................101
8.2 Scan measurement .....................................................................................................................102
9 Example of use ............................................................................... 105

9.1 Defining and Running the Tests ..................................................................................................105
9.1.1 Tests Definition ....................................................................................................................106
9.1.2 Layout Definition .................................................................................................................108
9.1.3 Performing Measurement ....................................................................................................109
9.2 Viewing and Printing ..................................................................................................................112
10 Appendix ....................................................................................... 115

Appendix 1. Printout examples .........................................................................................................116
Appendix 2. Scan data export format ...............................................................................................120
Appendix 3. Quick Test export format ...............................................................................................121
Appendix 4. List of tables and graphics.............................................................................................122
© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft III

Operating Manual
1 Introduction
AUTOsoft is a flexible, powerful and user friendly control and evaluation software. It is
designed to control the full range of microplate based measurement devices offered by
Autobio.
The features of AUTOsoft combined with Autobios sophisticated measurement
technology make it the ideal tool to run your tests, evaluate your results and manage
them on a patient based level.
The flexible function levels of AUTOsoft allow test programming and data evaluation
protocols covering the range from routine to complex scientific research.
With Autobios origin in the diagnostics business, we have made use of our expertise to
design a software tool tailored to the needs of our customers and the wide range of
microplate based applications they are performing.
Instrument control
Designed as a common platform, all microplate based measurement instruments
manufactured and marketed by Autobio are seamlessly integrated into AUTOsoft.
We have made all efforts to make routine operation and assay setup with AUTOsoft as
simple and intuitive as possible, well aware that with the variety of equipment our
customers are using every day, only the best products can provide best support to the job.
Flexible and simple assay setup and operation

Database storage
Data is stored in a database for safety and flexible access to your valuable data.
User administration
AUTOsoft provides access control by user name and password for 2 different
authorization levels.
Replicate elimination, validation and quality control

Criteria for replicate elimination can be defined to verify correct assay performance.
L-J-, instant- and Real-time method are available. QC Data can be added automatically or
manually.
Evaluation
Quantitative evaluation: Samples of unknown concentrations can be quantified using
various curve fits (linear regression, point to point, cubic spline and 4 parameter fit) with
linear and logarithmic axis scaling and optional extrapolation. Standard curves can be
saved and reused later on.
Qualitative analysis: based on up to 5 different cut off values can be used to assign
samples to up to different groups.
Semi-quantitative evaluation based on mathematical transformations.
Replication Formula combines the values of two replicates in a flexible formula to
provide a value different from the mean value to be used for further evaluation.
Titer Determination to determine titer classification across a series of dilutions of the
sample
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Operating Manual
AUTOsOFT
Scan data interpretation which performs a scan measurement, analyzes the scan profiles
to determine the reaction type for each well and finally determines the titer.
External Evaluation: In order to solve complex evaluation requirements the
corresponding calculation can be defined in an Excel workbook. AUTOsoft will perform
the related measurement, transfer the measurement results into a dedicated Excel
workbook, perform the desired calculation and return Quantitative and/or Qualitative
results to AUTOsoft for presentation and storage.
Variables can be used to replace fixed numerical values in various formulas related to the
test definition. The values assigned to the variables can be checked and altered upon
start of the test to correspond to the conditions of the specific test run (e.g. batch
specific reference values for controls, etc.)
Patient based data management

Detailed patient data can be added to the samples IDs and the related results. Patient
based result reports can be generated over time and across different assays.
Printout and Export

Matrix and sample data printout. Export of plate and sample data. Test and Layout export
and import.
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Operating Manual
2. Installation, Launch, Initial Setup AUTOsOFT
2 Installation, Launch, Initial Setup
This chapter covers installation, launching and the initial setup of AUTOsoft.
2.1 Installing AUTOsoft
2.1.1 System Requirements

Before installing the AUTOsoft software, refer to Table 2-1 to ensure the computer
system meets the minimum requirements. Where relevant recommended requirements
are listed.
Component Minimum Requirements
Operating Systems XP (SP2) | Vista (SP1) | Windows 7|Windows 8|Windows 10
Please observe the special instructions for the configuration
of Widows Vista provided under 2.1.2
CPU Celeron 1 GHz minimum
Celeron 1.7 GHz recommended
RAM 256 MB minimum
512 MB recommended
Monitor 1024×768 resolution (minimum)
Hard Drive 10 GB free disc space
Serial Port 1 free serial port RS232
or
1 free USB per instrument connected.
Table 2-1: AUTOsoft software system requirements
2.1.2 Special requirements for Widows Vista (Windows7/8/10)

In order to install the application under Windows Vista™ an additional step has to be
performed prior to installation which is not necessary under other versions of Microsoft
Windows. Due to the User Account Control (UAC) in Windows Vista, install actions that
require administrative privileges can be blocked. Since the installation of this application
requires administrative permissions, there will be problems in Vista if the UAC is not
turned off during installation. Before installing this application you must disable the UAC
within Vista, restart the system and then install the software. After the installation you
can enable the User Account Control UAC again.
If you need additional information on the UAC please check "Windows Help & Support"
on your specific Windows installation.
Disabling UAC under Windows Vista™

The following steps explain how to disable the UAC in Windows Vista:
1 Be sure that you are logged into an account that has administrative permissions.
Administrative permissions are required to install the software successfully.
2 Go to the start menu and select "control panel". This option should appear in the
right column of the start menu.

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AUTOsOFT
3 Open "User Accounts" in the control panel. This will display options to change
your user account settings under "Make changes to your user account".
4 Click the "Turn User Account Control on or off" option.
5 You will receive a dialog prompt, like the one below, asking for your permission
to continue. Click the Continue dialog button to proceed.
6 Now, the "Turn User Account Control On or Off" window will be displayed. There
is a checkbox below the window text with the caption "Use User Account Control
(UAC) to help protect your computer" If this box is checked, click the box to
uncheck it. Select the Ok button.
7 You will be prompted to restart your computer for the change to take effect.
Restart when you are ready, then run the software installation. After you install,
you can go back to the UAC and turn it on again.
Table 2-2: Disabling Windows Vista 'User Account Control' UAC
2.1.3 Running the Setup Program

The AUTOsoft setup program installs all components required to run AUTOsoft and
control the corresponding instruments.
Follow the steps listed below to install AUTOsoft:
1. Make sure you are logged on to the computer with full administrative rights. In
case you are not sure check the User Account under Windows system settings or ask
your System Administrator to perform the installation. An installation with limited
user rights may cause the application not to operate correctly. After the installation
by the administrator AUTOsoft can be run without administrator rights.
2. Exit all Windows programs before running the AUTOsoft software setup program.
3. Insert the AUTOsoft installation CD into the CD-ROM drive. After a few seconds, the
AUTOsoft software setup program appears
NOTE: If the AUTOsoft software setup program does not appear automatically, use
Windows Explorer to locate the CD-ROM drive and open Setup.exe.
4. Follow the instructions in the
setup wizard to install the
software.
When asked for the 'Customer
Information' please make sure
'Anyone who uses this computer' is
selected as installation option in
order to allow other Windows
users to run AUTOsoft on this
computer.
5. When the software installation is complete, choose [Close] to exit the setup
program.
6. Restart your computer and AUTOsoft is ready to use.
Table 2-3: Installing AUTOsoft – steps for setup

Operating Manual
2.2 Installation of USB-driver (optional)
If the instrument should be connected to the PC using a USB connection it is necessary to
install a USB-driver.
 First, connect the instrument and computer with a USB-cable.
 Turn the instrument on.
 Install the USB-driver by starting the USB-driver installation file on the CD or from a
download and follow the instructions shown on the screen.
 In order to identify the USB port used click START  RUN  enter 'devmgmt.msc' and
press Enter to start the Device Manager.
 Click on the '+' beside 'Connections (COM and LPT). The list of communication ports is
displayed and one entry shows 'USB Serial Port (COMx)' . 'x' indicates the port-number
assigned to the USB port which is the COM port to be selected to establish the
connection between the software and the instrument.
In case multiple 'USB Serial ports' are in use on the computer please check under
properties and identify the 'USB Serial ports' showing the manufacturer: 'FTDI'
Adjustment of the USB to Serial Port driver

In order to assure stable communication via the USB communication port it is
recommended to modify the settings for the FTDI driver (see above) according to the
following instructions.
Please Note!
The use of a USB cable different from the one supplied with the instrument may cause
communication problems.
Fig. 2-1: Select USB Serial Port in the Device Manager

USB_DeviceManager.png
 Click on the [Advanced] button and a new window is displayed titled 'Advanced
Settings for COMX' (X is the corresponding port number) see Fig. 2-3
 Click the [Defaults] button to reset all previous settings to their default value.
 Perform the following changes to the advanced settings as shown in Fig. 2-3
 Change the value for 'Latency Timer (msec)' to 1
 Change the two timeouts 'Minimum Read Timeout (msec)' and 'Minimum Write
Timeout (msec)' both to 1000.

Operating Manual
AUTOsOFT
Please Note: The above modification has to be performed for each new COM port
assigned to a USB port. If you change the USB port on the PC the instrument is
connected to, you will also have to modify the settings for the newly assigned COM port!
Fig. 2-2: Restore Default Settings for USB Serial Port

USB_PortSettings.png
Fig. 2-3: Modify Advanced Settings for USB Serial Port

USB_PortSettings_Advenced.png

Operating Manual
2.3 Running the Autobio Software
Double-click the desktop icon of AUTOsoft to start in the desktop to run it (see Fig. 2-4).
OR
From the Windows® Start menu, select Program>Autobio>AUTOsoft XX (xx = Version)
Fig. 2-4: AUTOsoft desktop icon
2.4 Error logging

Errors that may occur during operating AUTOsoft are saved in a log file named
errorlog.log, located in the installation directory. If an error is reported to your supplier
or directly to Autobio please include this file together with the detailed description of the
error symptoms and the situation the error occurs. The error log may contain valuable
information to identify the reason for the problem and help eliminating it or provide
assistance in preventing the error.
2.5 Initial setup of AUTOsoft

The first time AUTOsoft is launched, the following window (see Fig. 2-5) appears and you
are asked to enter some information related to the software license.
Please Note: The necessary License Code is provided by your local Autobio dealer who
supplied the instrument or as a file on the installation CD. Use the code according to the
instrument installed. Use the code according to the instrument installed and enter the
data exactly as provided.
The entry 'User Name' is also shown in report headers.
Fig. 2-5: License (example)

Enter the Instrument Type, User Code, User Name, Instrument Code and License Code as
provided by your local dealer, on the installation CD or in the installation archive (zip-file).

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AUTOsOFT
AUTOsoft can save license data of up to 3 different instruments which are then available
for selection under [Instruments]. In order to add license data after initial installation click
[Setup]  [License Data] select the desired instrument type and enter the license code
provided.
Instrument Type LUMO

User Code 1000
User Name Autobio Co., LTD
Instrument Code 1000
License Code 11111-22222-33333-44444-55555
Table 2-4: License information for AUTOsoft (example)
Click the [OK]-button to close the License-window.
Login in displayed (see Fig. 2-6).
Fig. 2-6: Login admin

Enter "admin" as User and as Password.
! Please Note:
The name of the user will appears in the bottom of the main window during running
AUTOsoft and on the protocol printouts for tests.
Change Password appears (see Fig. 2-7).
Fig. 2-7: Change Password

Select [OK]  AUTOsoft starts up (see Fig. 3-1).
OR
Select [Change Password]. Login expands to display password information and detailed
user information (see Fig. 2-8).
! Please Note
Only the user 'admin' authorized to create new, or remove obsolete users and assign/reset
passwords for other users!

Operating Manual
Fig. 2-8: Add New User

In "New Password", enter the new password. In "Confirm", enter the new password a
second time. Click OK. The user is logged in and the changed password is stored.
Next time the user logs in, the new password is required.
OR
In New User, enter a user name for the new user. Select Common Level or Super Level,
choose Add User, the new user name appears under 'User'. The user may log on using the
new user name and password next time.
The following table shows the rights assigned to the different user levels:
User / User Type Rights
Admin like User Type 'super' + the following rights:
Create/Delete users
Reset passwords of other users to default
Configure instrument parameters
Common Perform measurements
Add entries to the directory
Super Perform measurements
Add entries to the directory
Configure instrument parameters
Rewrite license code
Restore/Backup database
Initialize database
Table 2-5: Rights of different users / user types
Note:
The initial/default password for Common Level users is 123.
The initial/default password for Super Level user is 000.
The initial password for the Administrator user is admin.
Only the admin-user has the right to create or delete users and reset their passwords to
default.

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AUTOsOFT
A 'common user' or 'super user' can change his own password but cannot create new
users, delete users or change their password.
The operator logged in to AUTOsoft is displayed in the bottom right corner of the screen.
Reset admin password to default if password is lost

In case the admin-password has been changed from it's default setting and is then lost
please contact your distributor to receive a special program which will reset the admin
password to its default setting 'admin'. For data safety reasons this program is not
supplied in the installation files/CD.
2.6 Configuring Options

The following chapters summarize a number of features related to the general
configuration of AUTOsoft.
2.6.1 Data Export

This option is used to define the data fields to be exported into a text file when using the
'Export'-option accessible through the 'Export'-icon in the icon bar or through the menu
function Tools | Data Export (see 7.2). Select/Unselect the desired fields and click the
[Save]-button to save the settings which will be used until this setting is changed again.
'Allow automatic export' is used to enable automatic result export when the [Save]-
button is clicked after running a test or if a previously saved plate is opened.
‘Allow Sample ID prefix export’ is used to enable the complete sample ID to be exported
into the text file. If not ticked, only the last 4 digits of the sample ID will be exported.
‘Allow controls export’ is used to enable the results of Controls to be exported into the
text file.
Automatic Export Path displays the path that the text file automatically exports to, and
the path can be altered by clicking the […] button.

Operating Manual
Fig. 2-9: Setup | Options | Data Export

SetupOption_DataExport_221.png
2.6.2 Item Classification

Is used to group tests according to the specific structure in the lab. The use of this
feature is optional.
The left list titled 'List of items' contains general groups or the higher level structure.
The right list titled 'List of children' contains subgroups to the items listed in left list.
In order to add 'children' to a specific item previously entered, select the item in the left
list first (the right list automatically displays the related list of children) and then click the
[Add children] button. A box is displayed to add the desired entry.
In the current version of AUTOsoft a picklist with the Test Classes (items) is displayed
when selecting a previously saved test for measurement (under [Reading]). This makes it
easier to find a specific test in the list.

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AUTOsOFT
Fig. 2-10: Setup | Options | Item Classification

SetupOption_ItemClassification.png
2.6.3 Others
This tab summarizes two system related settings for the language and the printer colour
configuration.

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Fig. 2-11: Setup | Options | Others

SetupOption_Others_231.png
Language
Depending on the individual version AUTOsoft offers the possibility to select between a
number of operating languages.
From the Setup menu, select Language. Chose the desired language and click [OK]. You
will be asked to restart the application to run it in the selected language.
Printer Colour
Depending on the type of printer used the printouts can either use color or black and
white. Especially when using a black and white printer (e.g. laser printer) legibility is
improved when using the corresponding setting (black).
Unit
If LUMO is selected in Instrument Type, you can choose the light units based on
requirements. If RLU is selected, actual measurement value is displayed as the test result;
If ALU is selected, the actual measurement value is divided by 1000 and then displayed as
the test result. The default light unit is ALU.
Laboratory Name
The optional text entered in this field is displayed in the right top corner of all report
printouts. For examples see Appendix 1.
Show message after measurement is completed

If this option is activated a message is displayed after a measurement is completed,
asking the user to remove the plate from the instrument. It is advisable not to leave the

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AUTOsOFT
plate in the instrument for an extended period of time as humidity and especially
corrosive vapours may cause damage to the instrument.
2.6.4 Sample Info

This feature is used to facilitate data entry for Sample Information (see 6.1). In case you
only use a number of sample related data fields in routine use, you can uncheck all fields
you don't use. When entering the Sample Information and pressing the [ENTER]-key the
cursor will automatically jump to the next data field activated in 'Sample Info', thus data
entry can be performed more efficient. In case you still want to enter data to a data field
unselected in this feature you can either use the mouse or the [TAB]-key to navigate to
the desired data field.
Fig. 2-12: Setup | Options | Sample Info

SetupOption_SampleInfo.png
2.7 Configuring the Instrument

Initially, before the first measurement can be performed, the instrument setup has to be
run once. In order to perform the instrument configuration the user logged in has either
to be the Administrator (user name: admin) or a user with 'Super User' rights.
From the Setup menu, select Instrument and the following window appears (see Table
2-6). Its content depends on the type of instrument selected.
Simulator Data defines the filename which is used as source for virtual measurement
data if 'Virtual' is activated during a test run (see 5.1).

Operating Manual
Instrument configures the type of instrument to
be controlled, the related communications setting
and the serial interface of the computer the
instrument is connected to.
If the instrument is connected to a USB interface
of the computer, the USB-Serial driver has to be
installed and the appropriate COM-port
assignment has to be determined and set. (see
2.2)
The [Test]-button is used to verify if the
connection has been established successfully . In
this case a message box showing 'Instrument
connected' is displayed.
In case the connection has failed the message
shows 'Connection failed' and the port setting has
to be changed, saved and checked again by
clicking the [Test]-button.
Choose [Save] to save the new setting. Instrument
window closes.
Setup | Instrument dialog LUmo

In case PHOmo is selected as instrument type the
instrument setup window is displayed as shown
left.
[Test]
[Save] transfers the list of filters as displayed
under Filters 1 to 8. In case filters have been
added to the filter slider add the new wavelengths
to the filter list and click [Save] to update the list
of filters on PHOmo. The instrument will
automatically perform an adjustment procedure
after clicking the [Save]-button.
[Exit] Closes the Set| Instrument dialog.
Setup | Instrument dialog PHOmo

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AUTOsOFT
Operations PHOmo and LUmo:
[Eject Plate] is used move the plate transport out
of the instrument. (PHOmo+LUmo)
[Eject Filter] is used to eject the filter slider. It will
move out of the back of the instrument. (PHOmo)
[Move Home] moves the plate transport and the
filter drive into their corresponding home
positions. In case the filter slider has been
removed and reinstalled use this button to move
the filter slider into the instrument after placing it
back into position. (PHOmo)
[Read Filter] transfers the list of filters saved on
the instrument and displays it under 'Filters'.
(PHOmo)
[Write Filter] after a change to the filter list [Write
Filter] transfers the list of filters displayed to the
instrument and stores it there. (PHOmo)
[Gain Adjustment] After the filter list has been
modified and saved to the instruments memory
'Gain Adjustment' has to be performed to initially
adjust the light source energy and amplification.
(PHOmo)
[Transport Adjustment] will perform an automatic
adjustment procedure to for the plate transport
system. (PHOmo+LUmo)
[Servo Adjustment] will perform an automatic
adjustment procedure to determine the correct
servo positions for the two LED light sources)
(PHOmo)
[Dark Value Monitor] This function is for technical
service purposes and locked by password (LUmo)
[Get ErrorCode] transfers the most recent error
code from the instrument and displays it. 'Error
Code 0' corresponds to no error. (PHOmo+LUmo)
Table 2-6: Setup Instrument Dialog

Instrument_LUMO.png + Instrument_connected.png + Instrument_PHOMO.png
In order to verify the correct connection setting return back to Main Screen and click on
[Reading] icon. The second entry in the status-line at the bottom of the screen indicates
the status of the connection to the instrument. When the Reading function is opened the
first time after starting AUTOsoft the connection is established which may take a short
while.

Operating Manual
2.8 Directory
The Directory offers a way to customize AUTOsoft to your laboratory organization and
make the routine work simpler and more efficient. The Directory stores commonly used
expressions and data and helps managing reagent batches.
The following chapter describes the function of the Directory and it's various tabs in
detail.
Common Buttons
All tabs under Directory have the following common buttons:
Change Modify the selected item
New Create a new item
Delete Delete the selected item
Save Save a newly defined or modified item
Exit Back to Main screen.
! Unsaved changes will be discarded.
Section Office
… can be used to store the names of the various sections, departments, within the
organization supplying the samples. The list created here is used to assign the related
'Section Office' to a sample.
The number (No.) can be freely assigned and can also be used to refer to existing
numbering systems within the organization.
Fig. 2-13: Directory | Section Office

Directory_SectionOfice195.png
Region
… can be used to store the names of the various regions the samples processed in the
lab are originating from. The list created here is used to assign the related 'Region' to a
sample.

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AUTOsOFT
Fig. 2-14: Directory | Region

Directory_Region195.png
Deliver Doctor
… can be used to store the names of the doctors delivering patient samples to the
laboratory. The list created here is used to assign the label 'Deliver Dr.' to a sample.
‘Section Office’ is used to assign a Deliver Doctor to a certain Section Office. After
selecting an entry of Section Office in the Sample window, all doctors assigned to this
entry will appear in the drop-down list of Deliver Doctors.
Fig. 2-15: Directory | Deliver Doctor

Directory_SdeliverDoctor195.png
Sample Type
… can be used to store a list of sample types used for assays processed on AUTOsoft in
your laboratory. The list created here is used to assign the label 'Sample Type' to a sample.

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Fig. 2-16: Directory | Sample Type

Directory_SampleType195.png
Unit
… can be used to store a list of units for quantitative test results. The list created here is
used to assign the label 'Units' in the 'Quantitative'-tab of the 'Test Definition'.
The number (No.) can be freely assigned and defines the order of the entries in the list.
Fig. 2-17: Directory | Unit

Directory_Unit195.png
Remark
The number (No.) can be freely assigned and defines the order of the entries in the list.
The defined remarks can be selected from a picklist when defining a test in the
'Reference'-tab (see 4.1.6).
Fig. 2-18: Directory | Remark

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AUTOsOFT
Directory_Remark195.png
Reagent
… can be used to store a list of Reagents used for assays processed on AUTOsoft in your
laboratory. The list created here is used to assign the Reagent and it's specific data used
for a test when the result are stored by clicking [Save] in the Start Test window after the
Test is processed.
The "Reagent-data" is show when saving a plate, in the table of Saved Plates and on the
related printouts.
Fig. 2-19: Directory | Reagent

Directory_Reagent19.png
No. The number (No.) can be freely assigned and defines the order of the
entries in the list. In case of the Reagent the "No." is added in front of
the Name when it's shown in the list of Reagents for selection.
Name Name of the Reagent/kit
Manufacturer Manufacturer of the Reagent/kit
Batch Batch of the Reagent/kit
Expiry Date Expiry date of the Reagent/kit
External Tests
This tab can be used to save data on commonly used tests which are not performed on
the connected instrument and evaluated in AUTOsoft, but which can be saved in the
'Results'-tab of a sample to complete the sample related data (see 6.1).

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Fig. 2-20: Directory | External Tests

Directory_ExternalTests.png
No. The number (No.) can be freely assigned and defines the order of the
entries in the list. In case of the Reagent the "No." is added in front of
the Name when it's shown in the list of Reagents for selection.
E-Name Alternative Test Name (optional)
Test Name Name of the Test
Unit The unit of the result in case the test provides a quantitative result
Qualitative In case of a qualitative Test the possible results for the individual test
can be saved in this field (optional)
Reference 1-6 Additional information to be added to the result (to be shown in the
sample printout)

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AUTOsOFT
3 Main Screen
3.1.1 Main Window
After the user has logged in AUTOsoft starts showing the following screen.
Fig. 3-1: Main Window

Main_Window_ neutral.png
The functions can be accessed through the items shown in the menu bar and the most
common ones can be reached by clicking on the corresponding icons.
3.1.2 Menu Bar

Saved Plates
Samples:
Access all previously measured/evaluated samples.
Create sample numbers and add additional
information which can be used to fill the plate with
identified samples.
Open Saved Plate:
Access all previously measured plates to view,

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3. Main Screen AUTOsOFT
recalculate and print the results.
Reference Curve:
View the list of previously stored standard curves or
create a manually entered reference curve.
Test Definition
Single Test Definition(see 4.1):
Define a test method for an individual assay with all
relevant parameters for measurement and evaluation.
Access all previously programmed tests.
Layout Definition (see 4.1.4):
Define a plate layout – assign the location of all special
positions (blanks, controls, standards, etc.) for a
particular method on a plate. Layouts are stored and
used when running a test.
Multitest Definition(see 4.3):
Combine up to 12 Single Tests to be processed
together on one plate.
Reading
Start Test (see 5):
Run a test, based on a previously defined test method.
Assigned samples to the plate
View and print results
Quick Test (see 8.1):
Is used to perform a measurement without evaluation.
The measurement data can be printed to a matrix
report or exported to a file for further processing.
Scan (see 8.2)
is used to perform a scan measurement, display the
related data and export it to an importable text file.
This function is only available if PHOmo is selected as
instrument!
Tools
Internal QC (see 7.1)
Is used to monitor values of controls over time and test
runs and apply rules based on statistical parameters to
identify undesired variations or tendencies.
Data Export (see 7.2):
Export result data (per test/plate) to a text file or to a
printer.
Restore of Backup Database (see 7.3):
… is used to save the current database to another
drive and if necessary restore it.
Repair Database (see 7.4):
…can be used to repair a damaged database.
Compress Database (see 7.5):
… is used to optimize the database file and make it
smaller.
Initialize Database (see 7.6):

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AUTOsOFT
… clears all parameters form the database.
Log Viewer (see 7.7):
… provides access to information on manually
changed measurement results and added test results.
Setup
Change User (see 2.4):
Log in as another user
Printer:
Select the printer to be used
Directory (see 2.8):
enter various data which can afterwards be selected
from 'pick lists' (e.g. Sections, Sample Type, Units,
Remarks, Reagent).
Instrument (see 2.7):
Select the instrument to use with AUTOsoft, set
interface, read relevant configuration (filters for
reader).
License Code (see 2.4):
Enter the license code and related information.
Options (see 2.6)
Data Export: Select database entries to be exported
when using the 'Tools | Export Data' option (see 2.6.1)
Item Classification: Is used to group tests according to
the specific structure in the lab. The use of this feature
is optional (see 2.6.2)
Language: Select the language in which AUTOsoft
should be operated. Currently English, Chinese and
German are available (see 2.6.3).
Help
About:
… provides information on the version of AUTOsoft
and the license.
Exit
… closes AUTOsoft
Table 3-1: Menu Bar
3.1.3 Toolbar
By clicking on the corresponding icon some of the main functions accessible trough the
Menu Bar are directly started.
Reading | Quick Test (see 8.1)
Reading | Start Test (see 5)

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3. Main Screen AUTOsOFT
Open Saved Plates (see 6.2)
Saved Plates | Samples (see 6.1)
Test Definition | Single Test (see 4.1)
Test Definition | Layout Definition (see 4.1.7)
Test Definition | Multitest (4.3)
Setup | Directory (see 2.8)
Setup | Instrument (see 2.7)
Tools | Internal QC (see 7.1)
Tools | Export Data (see 7.2)
Setup | Change User

Opens the login box so a different user can login.
Table 3-2: Tool Bar

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AUTOsOFT
4 Defining Test- and Layout
Before you are able to run a test with AUTOsoft it is necessary to define the details on the
measurement, the evaluation method which has to be applied to the measurement data
and the assignment of the various sample types to locations on the microplate according
to the specific requirements of the assay to be performed.
This chapter covers all information:
 necessary to define a test according to the specific requirements on an assay (see 4.1)
 related to the definition of layouts which assign the corresponding sample types to
certain locations on the microplate (see 4.1.4).
 necessary to prepare a so called Multitest – which assigns up to 12 different,
previously programmed Tests to a single 96-well plate. (see 4.3)
4.1 Test Definition

A Test in AUTOsoft summarizes all information related to the measurement and
evaluation of the assay to be performed. Programmed Test are stored in the database
and selected at the time an individual plate carrying an assay should be measured and
evaluated.
The Test Definition is split into 3 parts which can be selected by clicking on the
corresponding tab:
 General: defining general parameters like the Test Name, the Test mode,
Transformation and the measurement parameters (see 4.1.1)
 Quantitative: defining all parameters related to a quantitative evaluation like standard
concentrations, curve fit mode, axis scaling, etc. in case a quantitative evaluation is
required.(see 4.1.2).
 Qualitative: defining all parameters related to a qualitative evaluation like Cut-off
values and range names. (see 4.1.3)
 Validation (see 4.1.4)
 Shaking: is used to set the parameters for shaking prior to the measurement defined
for the test. (see 4.1.5)
 Reference: : is used to add predefined information which is shown as description in a
Sample Result Report (see 4.1.6)
 Advanced: is used to select three special functionalities of AUTOsoft, the 'Titer Test' to
determine titer classification across a series of dilutions of the sample and the 'Scan
Mode' which performs a scan measurement, analyzes the scan profiles to determine
the reaction type for each well and finally determines the titer and the definition of
variables which can be modified when starting a test and can replace numerical values
in various formulas used in the test definition (see 4.1.7)
The following chapters cover all the details on the above functions of AUTOsoft.
List of saved Tests

On the left side of the Test Definition window always the list of previously programmed
and stored tests is displayed. By selecting the required Test its details are displayed in the

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4. Defining Test- and Layout AUTOsOFT
right section of the window.
The list which is opened when clicking on 'All Tests' shows the list of Test Classes which
may be assigned to the individual Test (under 'Class' in the General-tab). If a Test Class is
selected only the Tests assigned to the related Test Class are displayed in the list of Tests.
The Test Classes are defined in the 'List of Items' under Setup | Options | Item
Classification (see 2.6.2)
4.1.1 Test Definition | General
Fig. 4-1: Test Definition General

TestDef_General..png
Class
Class (Left) Select the class the programmed test should be assigned to
(see 2.6.2)
Sub-class (right) Select the Sub-class (child) the programmed test should be assigned
to
[…] opens the window 'Item Classification' accessible through
Tools|Options|Item Classification (see 2.6.2)
Test Name
Test No. The number of the test as shown under 'No.' in the table of tests.
You can use Test Numbers to structure your saved Tests according to
your requirements by using number groups like e.g. 1xx, 2xx, 3xx for
specific groups of test (xx will then be the number of the individual
Test in the Test group).
Pr. Index The order of individual test results if several of them are printed for
a specific Sample ID.
E-Name English name. Can be used if a Test has an English name beside the

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AUTOsOFT
name in the local language
Test Name The name of the test as shown under 'Name' in the table of tests
Measurement Parameters
Instrument Type The type of Instrument on which the test will be delivered
Luminescence Depending on the instrument you select (and configured under
or [Instrument])
Photometric
Meas. Filter For photometric measurement only! If LUmo is selected as
Ref. Filter instrument this entry is disabled.
Select the measurement filter and optional the reference filter. If a
reference filter is selected a measurement at both wavelengths is
performed and the difference of both measurement values is used
for further calculation/evaluation
The wavelengths have to be selected from the list of filters which
has been loaded when the instrument has been selected!
Meas. Time For luminescence measurement only! If PHOMO is selected as
instrument this entry is disabled.
Select the integration time for the luminescence measurement.
0.1 sec to 10sec in increment of 0.1 sec
Enter 1 for 0.1 seconds integration time
Enter 100 for 10 seconds integration time
Mode
Quantitative Depending on the necessary evaluation select either [Quantitative]
or or [Qualitative]. According to this setting only the parameters under
Qualitative the related tab can be defined.
In case the assay requires a qualitative evaluation of the calculated
concentrations the necessary selection has to be done under the
Quantitative-tab (see 4.1.2)
Please Note! If the 'Titer Test' function is activated, then 'Qualitative'-
mode has to be activated!
Transformation
A formula is defined which is applied to the measured values (RLUs)
on the plate.
The formula may contain:
- X representing the measured value of the sample
- Controls (NC1 to NC6 and PC1 to PC6)
- Standards (S1 to S8)
- 0-Standard (B0)
- F for Factor uses the individual, well specific Factor (dilution factor)
as defined in the layout as parameter in the formula.
- Numerical constants
- Variables V1 to V6 (see 4.1.7)
- min(a;b), max(a;b) returns the minimum or maximum of the two
values
- pwr(a;b) calculates a by the power of b  ab
- Mathematical operators (, ), +, -, * ,/ ,<=, >=, =, >, <

Operating Manual
Example: X'=X/(B0-X)
Please Note: Make sure Controls and Standards used in the formula
are also available in the layout used to run the test!
Please Note: If a transformation formula is defined the standard
curve graph will automatically be shown with the transformation
result for the defined standard points on the Y-axis (instead of the
related measurement value).
Description: Text label describing the transformation value.
Replication Formula
If the plate layout includes samples with two replicates this formula
can be applied to calculate a value based on:
- the two replicates R1 and R2 (always counted from top to bottom
and from left to right)
values
- pwr(a;b) calculates 'a' by the power of 'b'  ab
Results of the Replication Formula are available for further
calculation as Transformation results. The mean value of the
replicates is still available for further calculation if 'Meas. Value' is
selected as base.
R'=R1-R2 … will provide the value of
(measurement value 1st replicate) – (measurement 2nd replicate)
Please Note!
If a Transformation Formula is also defined, it will use the results of
the Replication Formula as input and supply the final result after
both formula calculations as Transformation result.
Default Layout
This feature can be optionally used to assign a previously saved
layout as default to a test. The layout selected here is automatically
displayed under 'Saved Layouts' when the related Test is selected
under 'Start Test'.
The […] button is used to open the 'Layout Definition' in order to
create and save a new Layout and return back to 'Test Definition'.
Other Buttons
[Export] Exports the selected test to a file so it can be imported to another
installation of AUTOsoft. The exported file is automatically stored in
the installation directory of AUTOsoft. The filename of the exported
file is created in the format TestSave_TESTNAME.tst.
[Import] Imports a previously exported Test (TestSave_TESTNAME.tst, see
above) into the AUTOsoft-database.
A widow is opened showing all available stored test in the default
directory (installation directory of AUTOsoft). Select a file and click
OPEN to import the Test into your database.
The Test Number and the Test Name is added according to the
exported Test.
If a Test with the same Test Number is already stored in the

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AUTOsOFT
database it will not be overwritten but you will have two entries
with the same Test Number.
[New] Start programming a new Test. You will be asked to enter the
desired Test Name which will be automatically shown in the
corresponding field.
The new Test will have the next higher Test Number assigned. If you
want to change it you can modify it in the General-tab and save the
Test. It will then show the new Test Number.
[Save] Save a newly programmed or modified Test.
Please Note!
If you don't click [Save] before [EXIT] or selection of another Test
your previously made changes to the Test will be discarded.
[Save As] Save a modified Test under a new Test Name. The Test No. will be
automatically set to the next higher Test Number. Accordingly the
newly saved Test will be shown at the bottom of the Test table.
[Delete] Delete the selected Test. Confirm with OK.
[Exit] Exit Test Definition. Return to Main Screen.
Table 4-1: Test Definition Parameters – General

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4.1.2 Test Definition | Quantitative
Under the [Quantitative]-tab all parameters necessary to define a quantitative evaluation
of a particular assay are summarized.
Fig. 4-2: Test Definition Quantitative

TestDef_Quant.png
Units
The unit of the concentration determined in the quantitative
evaluation. Pick the desired value from the list or enter it manually.
The list displayed for selection of the Unit can be created/modified
under Directory > Unit (see 2.8)
Standards
Please Note: Tests using a saved standard curve
If a test run should be performed using a saved reference curve the
same Test can be used without modification. AUTOsoft automatically
determines if the layout used for a test run incorporates all standards
defined in the 'Quantitative'-tab of the test. If the layout includes no
standards or only one or two standards the user will be prompted to
select a previously stored stand curve.
Depending on the number of standards present in the layout the
selected standard curve will either be used without adjustment (no
standards) or corrected based on one or two standards present in the
layout.
[Qualitative] Select this option if the test should also perform a qualitative
evaluation of the concentrations determined in quantitative
evaluation.
Concentration
Enter the corresponding concentration values for the standards.

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AUTOsOFT
The concentrations have to be entered in a steady ascending or
descending order.
Please Note: If a standard with a concentration of 0 is defined and
log scaling is selected for the X-axis the program will automatically
eliminate the related standard point from the standard curve and
concentration calculation. A message box is displayed to show the
modified calculation. The (matrix) report indicates this by showing
the standard data for the related standard in strike through format.
Extrapolation
Down Select if the standard curve should be extrapolated below the lowest
standard.
Up Select if the standard curve should be extrapolated above the highest
standard.
Curve
Point to Point Connects the standard points with straight lines.
(at least 2 standard points required)
Linear Calculates a linear regression over all standard points and creates a
Regression straight line with the calculated slope and offset.
Cubic Spline Calculates a curve which passes through all standard points
4-Parameter Fit Creates a sigmoid curve by calculating an upper and lower
asymptote, the maximum slope and the turning point.
(at least 4 standard points are required.)
Axis (X/Y)
Lin/Lin X-axis linear scaling | Y-axis linear scaling
Log/Lin X-axis logarithmic scaling | Y-axis linear scaling
Please Note: For treatment of standards with a concentration of 0
see 'Concentrations' above!
Log/Log X-axis logarithmic scaling | Y-axis logarithmic scaling
Please Note: For treatment of standards with a concentration of 0
see 'Concentrations' above!
Lin/Log X-axis linear scaling | Y-axis logarithmic scaling
Log/Logit Used to create a Logit-Log Plot with 'Linear Regression' as Curve
Mode. The axis scaling is Ln/Log.
Please Note!
In order to use this scaling mode B0 (0-Standard) must be present in
the layout. AUTOsoft will automatically use the transformation
X'=X/(B0-X) which is necessary for this special curve fit mode (the
transformation doesn't have to be defined manually).
Use axis labels Select this option to change the default axis label.
Axis Labels Enter the axis label for X- and Y-axis. By default the labels show
'Conc.' for the X-axis and either 'OD', 'RLU' or 'Transf.' for the Y-axis.
Validate Curve

Operating Manual
YES / NO If YES is selected the defined 'min. correlation' (default 0.99) is used
as the lower limit of the coefficient of correlation for the linear
regression to validate the curve.
For other curve modes this feature is disabled.
Default 0.99. The lower the value the smaller the correlation.
Min. Sensitivity
Enter the test specific lower detection limit. Any sample giving a
concentration below this value will show '<MinConc' (MinConc will
correspond to the value defined as Min. Sensitivity) as concentration.
If the concentrations are classified ([Qualitative] ticked – see above)
samples below 'Min Sensitivity' will be assigned to group below the
lowest cutoff value.
Risk of 2 Stds (Only applies to LUMO)
YES / NO If YES is selected, the Risk of 2 Stds function is enabled. The value
entered(default: 20%) is the upper limit for evaluation of difference
between the original reference curve and the new curve. For
example: Use S2 and S5 to adjust the curve. If the values are too
high or too low, a risk message will pop up.
Table 4-2: Test Definition Parameters - Quantitative
4.1.3 Test Definition | Qualitative
Fig. 4-3: Test Definition Qualitative

TestDef_Qual_V220.png
Groups
AUTOsoft supports up to 5 cutoff values and accordingly the assignment of samples to
up to 6 groups. Cutoff 1 has the lowest and Cutoff 5 highest value. Accordingly the
assignment is performed as follows: Group 1 < Cutoff 1 < Group 2 < Cutoff 2 < Group
3 < Cutoff 3 < Group 4 < Cutoff 4 < Group 5 < Cutoff 5 < Group 6

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AUTOsOFT
Group 1 to Enter the label which should be used to assign a sample to the
Group 6 corresponding group.
To highlight sample positions assigned to the Groups click on the
colored rectangle beside the Group label and select the desired color.
After evaluation the text entries in the matrix for all positions assigned
to the related Groups are displayed in the selected colors. By default
the color is set to black.
Cutoff 1 to Limits used to separate the assignment of values to a certain group.
Cutoff 5 The Cutoff can be defined as a numerical value or as a formula.
The picklist located to the right of the first Cutoff Definition is used to
select if the qualitative evaluation should be based on the 'Meas. Value'
(RLU), 'Transformation' or 'Concentration' in case the previous
evaluation supplies this kind of result data.
The formula defining the Cutoff value may contain:
- 0-Standard (B0)
values
Examples:
PC1*0.5 (the Cutoff is 50% of PC1)
max(NC1;0,05) (the Cutoff is either NC1 or 0,05 whatever is larger)
Please Note: Make sure Controls and Standards used in the formula are
also available in the layout used to run the test!
M/CO Is used to select the Cutoff value which should be used to calculate
M/CO (Measurement Value / Cutoff Value).
The value calculated is used in Internal QC (see 7.1.3)
Table 4-3: Test Definition Parameters – Qualitative
Please Note! If 'Titer Test' is activated in the 'Advanced'-tab 'Cutoff 1' is used to
separate negative samples from equivocal or positive samples. The 'Titer Test'-function
then indentifies the highest dilution of the sample which still shows a positive or
equivocal classification.

Operating Manual
4.1.4 Test Definition | Validation
Fig. 4-4: Test Definition Validation

TestDef_Validation_V220.png
Replicate Rejection
Replicate Rejection is used to eliminate values within replicated standards, controls and
samples from further calculation based on specific criteria defined by formula.
Formula The Formula defines the criteria which has to be met for each individual
replicate. If a replicate doesn't meet the criteria it is rejected and not used
for further calculation.
- 0-Standard (B0)
- Variables V1 to V6 (see 4.1.7.4)
- min(a;b), max(a;b) returns the minimum or maximum of the two values
- Logical operators AND and OR are used to combine different criteria
Please Note: 'AND' and 'OR' have to be separated from the adjacent parts
of the formula by a space before and after the logical operator.
Example:
PC1*0.9<PC1X<PC1*1.1 (all replicates of PC1 have to range within +-
10% from the mean value of PC1)
PC1X>100000 (all replicates of PC1 have to be greater than 100000)
Base 'Meas. Value' (depending on the measurement method) or
Calculated concentration – as determined for the individual well

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AUTOsOFT
Min. Repl. Enter the minimum number of valid replicates necessary after replicate
rejection for the test to remain valid.
Validation
Validation is used to define up to two criteria which have to be met to verify validity of
the results of a test based on a formula.
Formula The Formula defines the criteria which has to be met. If more than one
criteria is defined both have to be met to make the Test valid.
- 0-Standard (B0)
- Blank (BL)
- Variables V1 to V6 (see 4.1.7.4)
- min(a;b), max(a;b) returns the minimum or maximum of the two values
- Logical operator AND and OR are used to combine different criteria
Please Note: 'AND' and 'OR' have to be separated from the adjacent parts
of the formula by a space before and after the logical operator.
In case replicates are used Controls and Standards used in the formula are
based on the mean of their replicates.
Example: PC1>100000
Base 'Meas. Value' (depending on the measurement method) or
Calculated concentration – as determined for type of sample
In case replicates are defined Controls and Standards used in the formula
are based on the mean of their replicates.
Table 4-4: Test Definition Parameters - Validation

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4.1.5 Test Definition | Shaking
Fig. 4-5: Test Definition Shaking

TestDef_Shaking_V220.png
Shaking
Enable Shaking Tick the 'Enable Shaking'-box to perform shaking prior to the
measurement with the following settings.
Intensity Low, Medium, High
Time 1 to 99 seconds
Table 4-5: Test Definition Parameters - Shaking

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AUTOsOFT
4.1.6 Test Definition | Reference
Fig. 4-6: Test Definition Reference

TestDef_Reference_V220.png
Reference Value (optional)

1 to 6 The content of these entries will be included in the sample report beside
the related result and can for example be used to add information about
applicable limits related to the parameter determined.
Remark
A general remark to be shown on the protocol. The picklist is filled with
entries that can be predefined under (see 2.8 Directory | Remark)
Table 4-6: Test Definition Parameters - Reference
4.1.7 Test Definition | Advanced

The functions summarized in the Advanced-tab are used to select and define four special
features of AUTOsoft:
'Titer Test' is used to perform a titer classification across a series of dilutions of a

sample located in replicates of the same sample ID (see 4.1.7.1).
'Scan Mode' is used for agglutination data reduction with titer determination based on
an external calculation module called AUTOaggl (see 4.1.7.2)
'Using an external calculation file' is used to link an external Excel™ workbook to

AUTOsoft which receives the measurement data and returns quantitative and/or
qualitative results based on an individual calculation performed in the Excel™ workbook
(see 4.1.7.3)
'Variables' are used to replace fixed numerical values in formulas used in the test
definitions. The values can be checked and modified when the test is started. This feature

Operating Manual
is important when using assays with batch specific values (see 4.1.7.4). When using
Variables with an External Calculation File these are used to transfer data and
information between AUTOsoft and the External Evaluation File - Excel workbook) (see
4.1.7.3).
4.1.7.1 Titer Test

The Titer Test feature is used to determine the specific Titer of a sample by classifying
individual replicates of a sample (each with a specific, predefined dilution) to negative
(assigned to Group 1) and others (equivocal and positive (assigned to Group 2 and
higher). The sample specific Titer is then expressed as the dilution ratio of the lowest
concentration providing a non-negative classification.
Please Note! If 'Titer Test' is activated in the 'Advanced'-tab 'Cutoff 1' is used to
separate negative samples (in Group 1) from positive samples (in Group 2). Additional
groups above Group 2 can be defined but will be irrelevant for Titer determination.
Layout
The Layout required for a Titer Test has to use the number of replicates per sample ID
corresponding to the number of required dilutions of the samples as shown in Fig. 4-7
(example with 8 replicates).
Please Note! Only samples positioned in the layout will be processed to determine the
corresponding Titer. If case special positions (PC, NC and K) are positioned in the layout
the Titer will not be calculated for them, but the values will be available for definition of
the Cutoff and for Validation.
Fig. 4-7: Layout definition with 8 replicates for Titer Evaluation (example)
Advanced_Titer_Layout.png
Factors

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AUTOsOFT
The sample dilutions to be assigned to each individual sample have to be defined and
stored as part of the Layout. The screen dump below (Fig. 4-8) shows an example of a
dilution sequence starting with a dilution of 1/40 and increasing by steps of ½ . The
dilutions have to be entered as dilution index (40 = 1/40)
In order to fill the dilution matrix efficiently:
 Select 'Factor' in Layout/Factor to display the Factor matrix
 Enter a dilution index in the field beside the 'Factor'-selector
 Do a right-click on the desired Row-label to fill the complete row with the defined
factor.
 Repeat the procedure with the different dilution indexes until the complete matrix is
filled.
 Click [Save] to save the Layout and Factors.
Fig. 4-8: Factor Definition for Titer Evaluation

Advanced_Titer:_Factors.png
Test programming
General information on the various Test-tabs are provided in chapter 4.1.
General–tab: Select the desired wavelength to be used for the measurement. Make
sure the 'Qualitative is selected as 'Mode'.
You may enter a 'Transformation' formula and use the Transformation results as basis for
the Qualitative classification of each individual sample dilution. This may be particularly
useful, to correctly assign Titers in case the reaction provides higher measurement values
for higher dilutions. In this case a formula like X'=1/X will reverse the order and after
applying the same calculation to the Cutoff (see below) the titers for the samples will be
correctly assigned.
Select the previously defined layout as described above as 'Default Layout'.

Operating Manual
Quantitative-tab: Leave all entries empty. As 'Qualitative' has to be selected as 'Mode'
in the General-tab entries to this tab are disabled anyhow. When using the Titer-Test
option Quantitative Evaluation is not supported.
Qualitative-tab: Define the value for Cutoff 1 to distinguish negative and non
negative (positive or equivocal sample dilutions) with negative samples assigned to
Group1 and positive or equivocal samples to Group 2 and higher.
In order to correctly perform a Titer Test, values below Cutoff 1 have to be considered
negative, values above Cutoff 1 as positive. For the Titer Determination equivocal samples
are considers positive. The names assigned to the groups can be freely defined.
If the assay shows a reversed ratio between dilutions and measurement values the
following message is displayed:
'TEST INVALID: Lower dilutions have to show higher meas. values and higher dilutions
lower meas. values. In this test the order is reversed so the results are invalid!'
In case you have defined a Transformation formula select the 'Transformation' as basis for
the further evaluation. In case special positions are defined in the layout these will not be
processed to provide Titers, but the measurement value (or in case of replicates the mean
measurement value) can be used in a formula to define the required cutoff.
The following table shows an example for better understanding of the calculation
performed. In this case position A6 with a value of 0.223OD is the first non negative
sample (assigned to Group 2) and therefore used to determine the sample specific Titer,
in this case 1/1280.
Cutoffs Position Meas. Value Titer Index Titer Group Classification

A1 0.614 1/40 40 3 +
A2 0.535 1/80 80 3 +
A3 0.457 1/160 160 3 +
A4 0.379 1/320 320 3 +
A5 0.301 1/640 640 3 +
Cutoff 2 0.250
A6 0.223 1/1280 1280 2 +/-
Cutoff 1 0.200
A7 0.145 1/2560 2560 1 -
A8 0.067 1/5120 5120 1 -
Table 4-7: Titer determination example
Validation-tab: Special positions on the plate (in the layout) can be validated based
on their measurement or transformation value. For details please refer to chapter 4.1.4)
Shaking-tab: configure settings as required (see 4.1.5)

Reference-tab: configure settings as required (see 4.1.6)
Please Note! In order to correctly perform a titer test values (measurement or
transformation) above Cutoff 1 have to be considered positive, values below as negative.

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AUTOsOFT
4.1.7.2 Scan Mode
'Scan Mode' performs a scan measurement, analyzes the scan profiles to determine the
reaction type for each well and finally determines the titer. It is dedicated to
agglutination assays which require an interpretation of a sequence of measurements
taken across each well of the plate. This function requires an external AUTOaggl
calculation module which is supplied on request only and has to be adjusted according
to the specific characteristics of the individual assay.
For detailed information on this special feature of AUTOsoft please contact Autobio by
email. Customized versions of the agglutination data reduction can be prepared to meet
the specific requirements of various agglutination based applications.
4.1.7.3 Using an External Calculation File

In order to support evaluation methods exceeding the standard evaluation features of
AUTOsoft an Excel workbook can be used for evaluation. In this case the measurement is
performed by AUTOsoft and the related data is transferred to a predefined Excel
workbook. The evaluation to be defined in Excel is based on the measurement data
supplied and the results calculated in the Excel workbook (quantitative and/or qualitative)
are returned to AUTOsoft for presentation and reporting.
! Please Note
In order to use the External Calculation feature Microsoft Excel® has to be installed on
the computer AUTOsoft is used on!
By default all related Excel files are located in the directory '\Advanced' below the
AUTOsoft installation directory.
Measurement data workbook

AUTOsoft uses the file ..\Advanced\plate1.xls (located in the AUTOsoft installation
directory) to transfer the measurement data to the external evaluation workbook. After
the measurement, the data of the most recent measurement is stored in this file and
remains available until the next measurement is performed. If the
file ..\Advanced\plate1.xls is not available prior to the first test run with external
evaluation it is automatically created at the correct location. Virtual measurement data
(from the file selected under 'Instrument | Simulation Data') is also transferred
to ..\Advanced\plate1.xls and is thus handled exactly like data from a real measurement.
The structure of the measurement data workbook corresponds to the first 12 lines (4
lines header and 8 lines with 12 measurement values) of the scan data file described in
Appendix 2)
Evaluation workbook
The evaluation workbook to be used to perform the external evaluation is selected in the
'Advanced'-tab in the Single Test definition as 'Calculation File'.
The first worksheet in the evaluation workbook (independent of its name) contains the
qualitative- and quantitative results to be transferred to AUTOsoft and an area defining 6
variables to be optionally defined, modified at the start of the test and used in the
individual calculation similar to the functionality described in 4.1.7.4.)
Content Location Description
Qualitative Results C16:N23 An 8x12 matrix including the qualitative results for

Operating Manual
all sample positions. If a position is empty the
corresponding position in the result matrix should
be left empty (show an empty string)
The labels used to indicate the classification of the
individual samples are not limited to the 6 groups
available in AUTOsoft.
Replicates: First sample position (from top to
bottom or from or left to right) represents the
results of the replicated samples. The other well
positions occupied by the same sample have to be
left empty in this area to allow a correct transfer of
the qualitative results of the replicates.
Quantitative C32:N38 An 8x12 matrix including the quantitative results for
Results all sample positions. If a position is empty the
corresponding position in the result matrix should
be left empty (show an empty string)
Replicates: First sample position (from top to
bottom or from or left to right) represents the
results of the replicated samples. The concentration
values of the other well positions occupied by the
same sample have to be set to 0 in this area to
allow a correct transfer of the concentration value
calculated for the mean values of the replicates. The
0-values will not be displayed in the report or result
view.
Variables Q17:S22 Variables (to be used with the external evaluation
sheet) can be used to transfer values and text
strings from AUTOsoft into the evaluation sheet or
back from the evaluation sheet to AUTOsoft.
The content of the variables defined in the
evaluation sheet is optionally displayed when a test
is started if 'Check Variables' is activated'.
Depending on the corresponding entry in Column Q
(see below) the content of the variable can be
modified or not at the start of the test.
Please Note: If the content of a variable is changed
when a test is started it's value is only changed for
the individual test run and not updated in the
evaluation sheet itself. If required the default values
have to be changed in Column R of the variable
definition area (see below)
Column Q: Defines if the value assigned to a
variable may be changed when the test is started or
not (from AUTOsoft).
SET: The value/content can be set/modified by the
user when the test is started
FIXED: The value/content cannot be set/modified by
the user when the test is started
If a variable is used to transfer a value from the

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AUTOsOFT
evaluation sheet to AUTOsoft the variable should be
set to 'FIXED'.
Column R: Defines the numerical value or content

of the variable as it is used in the evaluation or
transferred back to AUTOsoft. The entries in column
R can either be numerical values, strings (text) or an
excel formula which returns a numerical value or
string.
Please Note: If a string is used as variable content it
must not include the letters X, x, V, v, F, f, R, r! (in
the current version 2.3.2 these letters will be
interpreted as part of special sample labels and
cause an error if used). To overcome this limitation
for variable values/content to be transferred from
Excel to AUTOsoft you may use a formula to define
the variable value, which by default will show a
string without the above listed characters (e.g. '-')
and only show the final result string (which then
may include the above listed characters) as soon as
the measurement data file is either open/loaded
manually or automatically by AUTOsoft (see
example workbook sheet Calc!D16)
Column S: defines a description of the
corresponding variable as text and is displayed
together with the value under Results | Parameters
and in the table report.
Table 4-8: Content of the first worksheet in the evaluation workbook
Fig. 4-9: External Evaluation – 1st worksheet

External_sheet1_example.png

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Test Definition
The Test Definition of a Test using external evaluation has to be defined as following:
Tab Description
General In the 'Mode' area select the main evaluation method. Only if the
evaluation method is selected, the results will be correctly transferred
from the evaluation workbook into AUTOsoft..
'Quantitative' to transfer the concentrations and optionally additional
Qualitative evaluation results from the external evaluation sheet
'Qualitative' to transfer qualitative evaluation results from the external
evaluation sheet
'Transformation' can be optionally used to calculate a formula based
sample index value which is then available as result.
'Replication Formula' has to be left empty
For details see 4.1.1
Quantitative In the current version of AUTOsoft a standard curve has to be defined
if 'Quantitative' is selected as evaluation mode in the 'General'-tab even
if the quantitative results to be finally used are calculated in the
external evaluation sheet. The curve to be defined here is currently
used as dummy. Create a standard curve follow the instructions in
4.1.2. In order to also transfer qualitative results from the evaluation
sheet select 'Qualitative' in the area labeled 'Standards'.
Qualitative Leave the settings in the 'Qualitative'-tab empty. If 'Qualitative' is
selected as evaluation mode in the 'General'-tab or in the 'Standards'-
area of the 'Quantitative'-tab the corresponding results will be
transferred from the evaluation sheet.
Validation Replicate Rejection has to be left empty. If necessary this function has
to be to be programmed in the external evaluation sheet.
Validation based on measurement values can be defined as described
in 4.1.4
Shaking Define shaking parameters as described in 4.1.5
Reference Define Reference information as described in 4.1.6
Advanced Activate 'Using calculation file' and select the desired calculation file.
see the section titled 'Evaluation workbook' further above in this
paragraph.
Table 4-9: Test settings for external evaluation
Special considerations
Quantitative results:
Concentrations are checked against the valid range defined in the Quantitative Test tab.
Concentrations exceeding the limits of the standard curve defined in AUTOsoft are
marked as <X or >Y (X=concentration of lowest and Y=concentration of highest
standard) unless Extrapolation (Down and/or Up) is selected.
When using external evaluation to calculate concentrations AUTOsoft will show no
standard curve in the Result-tab or the Matrix printout.
Sample concentrations below the value set in 'Min. Sensitivity'
… are displayed as <X (X=value set for Min. Sensitivity)

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AUTOsOFT
Concentrations for standards shown in the result matrix
… are based on the concentrations defined in the 'Quantitative'-tab in the test in
AUTOsoft.
Calculated concentrations shown in the table report
… correspond to the concentrations values for the standard positions supplied by the
Excel sheet according to the assigned layout.
Mean OD/RLU and CV%
are based on the measurement data of the replicates (as defined in the assigned layout)
and are calculated by AUTOsoft.
Replicates
If replicates are used the value in the first replicated sample position (from top or left) is
transferred as result to AUTOsoft.
Update to new version of AUTOsoft
After an update to a new AUTOsoft version the previously programmed evaluation
workbooks have to be copied or moved to the \Advanced directory below the installation
directory of the newly installed version. After copying the database of the previous
version to the newly installed version the references to the programmed tests using the
external evaluation feature have to updated to refer to the \Advanced directory of the
new version. This is done by opening the corresponding tests and changing the path to
the external calculation file assigned to the related test.
Example
The AUTOsoft installation will automatically copy the following files into the installation
directory to be used as an example for external evaluation. When running the test make
sure to select 'Virtual' (in the bottom left corner of the 'Start Test' window in order to use
the virtual measurement data file provided (see below).
External_Example.xls External evaluation file to demonstrate the
external evaluation function.
External_Example.txt Virtual measurement data file (with OD values) to
be used with External_Example.xls. Select this file
as 'Simulation Data' under 'Instrument'.
TestSave_External_Example.tst Test file for import ('Single'  [Import]) to be used
with External_Example.xls. The test performs a
photometric measurement on PHOmo and an
external evaluation based on External_Example.xls
Please Note: After import of the Test and Layout
open the newly imported test and check the
assignment of the default layout in the 'General'-
tab and the path of the Calculation File in the
'Advanced'-tab.
LayoutSave_External_Example.plt Layout file for import ('Single'  [Import]) to be
used with External_Example.xls
Table 4-10: Files to be used as example for external evaluation

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4.1.7.4 Variables
… are used to replace fixed numerical values in formulas used in the test definitions. The
values can be checked and modified when the test is started. This feature is convenient
when programming assays with batch specific values.
Fig. 4-10: Test Definition | Advanced | Variables

TestDef_Advanced_Var.png
Variables V1 to V6
Value Defines the value assigned to the related Variable. The value can either
be defined by a numerical value or by a formula using:
- 0-Standard (B0)
values
- Mathematical operators (, ), +, -, * ,/
Please Note: Variable formulas must not use X, V, F, R
Description An optional descriptive text can be entered to describe each individual
variable. The Description is displayed together with the assigned value
under 'Test Results'  'Parameters' and listed in the Table Report.
Check If 'Check Variables' is activated the list of Variables is displayed after
Variables starting the related Test, the values can be modified and the test run can
be continued by clicking [OK]. In this case the programmed test is
updated with the modified values as soon as the results are saved. The
next time the Test is started the updated values are displayed as default.
If the Variable values are modified in a previously measured and saved
Plate which has been opened and recalculated the variable values are
only changed for the opened plate and the Variable settings in the
original Test remains unchanged.
4.2 Layout Definition

The layout definition is used to define the assignment of samples and special positions to
the plate matrix and save if for use during a Test Run.

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AUTOsOFT
Layouts can be stored and the Layout corresponding to a particular Test can be selected
when a Test run is defined using the [Reading]-option. In case an individual layout is
required for a particular Test run the layout can also be defined individually. The
procedure of setting up the Layout is identical in both cases.
 Click [New] or select an existing Layout from the table of stored Layouts
 Select the number and direction of the replicates. This can be changed during the
definition of the sample positions to allow for different replicate settings for various
types of samples.
 Select the Type of sample. 'Current Type' shows the sample type to be positioned. It is
automatically incremented after positioning a sample of the selected type. The
number can be changed by clicking the corresponding up and down arrows.
 Position the sample by clicking to the corresponding position in the plate matrix.
To delete a previously positioned sample right-click on the related position.
 Repeat until all special positions are set.
 General samples can be positioned automatically. Select the 'Filling Direction'
corresponding to the plate type used (8- or 12-way strips) or your requirements.
Click [Fill] and all remaining positions will be filled with patient samples (P) according
to the selected configuration (filling direction, replicate settings).
After selecting the sample type 'P' a column or row can be filled by clicking on the
corresponding column- or row-label. Previously positioned Standards, Controls, etc.
will not be overwritten when filling a row or column but previously positioned
samples will be overwritten. Replicate setting are ignored when using this function.
A right-click on the corresponding row/column-label will delete all previously
positioned Samples, Standards, etc.
Alternatively hold the left mouse button down and drag a rectangle to be filled with
the selected sample type. A dotted line marks the area selected. When releasing the
left mouse button the selected area is filled with the selected sample type using the
defined filling direction and replicate parameters. Previously positioned samples are
not overwritten.
For details on the various functions refer to the information provided in Table 4-11.

Operating Manual
Fig. 4-11: Layout Difinition

LayoutDefinition.png
Type
Select the type of sample to be placed in the template
P Patient sample
S Standard (S1 to S8)
NC Negative Control (NC1 to NC6)
PC Positive Control (PC1 to PC6)
BL Blank (will automatically be deducted from all measurement
values prior to any other calculation)
B0 0-Standard
K Control (K1 to K6)
Current Type Click up or down to manually increment or decrement the number of
the sample type selected (see above for numbers per type).
Filling Direction
Vertical or Defines the filling direction when using the [Fill] function (see below).
Horizontal Vertical = 8-way, Horizontal = 12-way
Fill Fills all empty - not previously assigned wells - with samples
according to the direction and replication parameters defined above.
Clear Removes all samples assigned to the template.
Clear All Empties the template by removing all samples and special positions.
View
Layout Displays the plate layout
Factor Displays the dilution factors for each sample location. By default the
factor is set to 1. (e.g. A dilution of 1:10 would have to be defined as
10)
The Factor is automatically used to adjust Calculated Concentrations
and the Results of the Transformation Formula by multiplying the
original result of the calculation by the Factor.

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AUTOsOFT
In case the Titer Calculation function is used in a test, the dilution
indexes for the individual sample dilutions have to be defined as
factors corresponding to the positions of the sample replicates in the
layout (see 4.1.7.1)
In order to assign Factors enter the desired value into the box beside
the 'Factor'-button (in the window area labeled 'Layout/Factor' and
either click on the desired individual position,. Or click on the desired
column- or line-indicator to fill the corresponding column or line, or
click on the left top rectangle (between 'A' and '1') to fill the complete
plate matrix with the same value.
The specific factor assigned to each well is also available in the
Transformation-formula as 'F' (see 4.1.1)
Replicate
Number Number of replicates of a sample to be created automatically when 1
sample is positioned. Default = 1 (no replicates)
please note: the auto replicate function is only applied if patient
samples (P) are automatically filled to the plate using the [Fill]-
button.
For replicated samples the mean value is automatically calculated and
replaces the measurement results per sample for further calculation.
Additionally a Replication formula can be defined which can be used
to calculate a transformation value based on the individual replicates
(see 'Replication Formula' in 4.1.1)
Direction Horizontal (12-way) or Vertical (8-way)
Other Buttons
[Export] Exports the selected Layout to a file so it can be imported to another
installation of AUTOsoft. The exported file is automatically stored in
the installation directory of AUTOsoft. The filename of the exported
file is created in the format LayoutSave_LAYOUTNAME.plt.
[Import] Imports a previously exported Layout (LayoutSave_LAYOUTNAME.plt
see above) into the AUTOsoft-database.
The Layout is stored under the next available Layout Number under
it's original Layout Name.
Please Note!
If a Layout is imported which is assigned as 'Default Layout' to a
Test the assignment of the imported Layout has to be verified in
the Test to make sure the correct Default Layout is used! Open the
related Test and select the imported Layout as 'Default Layout!
[New] Start programming a new Layout.
[Save] Save a newly programmed or modified Layout.
Please Note!
If you don't click [Save] before [EXIT] or selecting another Layout
from the list your previously made changes to the Layout will be
discarded.
[Save As] Save a modified Layout under a new Layout Name. The Layout No.
will be automatically set to the next higher Layout No. Accordingly
the newly saved Layout will be shown at the bottom of the Layout
table.

Operating Manual
[Delete] Delete the selected Layout. Confirm with OK.
[Exit] Exit Layout Definition. Return to Main Screen.
Table 4-11: Layout Definition

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AUTOsOFT
4.3 Multitest
A Multitest assay may combine up to twelve user-selected tests, with as many as six tests
combined on one plate. Based on the parameters of the tests selected AUTOsoft
automatically creates plate layouts for the assays.
From Test Definition menu, select Multitest or click on the corresponding icon titled
'Multi' (see Fig. 4-12).
Test – tab
Fig. 4-12: Multitest Definition

Multitest_Test.png
 Select [New] and enter the name of the Multitest to be created under 'Name:' Click OK.
 In 'Filter', select: 'EMPTY' for a Luminescence Multitest or
The desired filter (from the list displayed) for Photometric Multitest
 In 'No. of Tests', select the number of Tests to be used within the Multitest (up to 12).
 In T 01, T 02, …, select pre-programmed tests. The tests displayed for selection either
use the same 'Filter' or are Luminescence Tests (see Fig. 4-13).
 Click [Save] to save the current settings. Only after clicking [Save] the selected Tests
are made available in the following step Layout-definition.
Date Range
From / To As Multitests have to be defined together with a specific Layout to
accommodate the number of samples to be tested the Date Range
for stored Multitests can be defined. Only Multitests within the
specified Date Range are displayed in the List of Tests.

Operating Manual
[Refresh] Press the [Refresh]-button to update the list of Tests according to the
Date Range defined.
Details
Allow Edit Tick 'Allow Edit' to protect the settings for the Multitest from
changes.
Name When creating a new Multitest (after clicking the [New]-button) the
name of the new Multitest is created in the format.
'MultitestYYMMDD' and a window is opened to change it.
Meas. Filter In case AUTOsoft is used with LUmo select [EMPTY]. For a
photometric Multitest select the wavelength used for all Tests on the
Multiplate.
Ref. Filter The list of the Ref. Filter.
No. of Tests Define the number of Tests to be used in the Multitest. The Test
selection list (T.01 to T.12) below will be enabled/disabled according
to this selection.
T.01 to T.12 For each enabled Test select a Test to be processed in the Multiplate.
(see Fig. 4-13)
Other Buttons
[Exit] Exit Multitest Definition. Return to Main Screen.
Fig. 4-13: Select test

Multitest_TestSelect.png
 Layout-tab to define the layout. In 'Current Test', select the first Test and define its
layout corresponding to the procedure also used for Layout definition for a Single Test

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AUTOsOFT
(see Fig. 4-14). After the layout of portion of the plate holding first Test is completed,
proceed with the second test, etc. until the plate layout is completed.
The layout defined for the test can be modified if necessary when starting the Test
(see 5.6).
Corresponding to the Single Test, Multitests also support the use of saved standard
curves. Accordingly the layout for quantitative tests can include none, 1 or two
standards to be used to adjust the stored standard curve.
 Click on the 'Test'-tab and then click [Save] when the layout definition is finished.
Fig. 4-14: Multitest – Layout Definition

Multitest_Layout_.png
Date Range
From / To see above
[Refresh] see above
Test
Current Test Is used to select the Test for which samples should be positioned in
the Multitest Layout. Only Tests are listed which have been selected
in Test-tab of the 'Multitest Definition'.
No. of Samples Defines the number of samples which should be positioned in the
layout for the 'Current Test'
Type
Is used to select the type of sample to be positioned (see 4.1.7)
Filling Direction
Defines the filling direction and provides the possibility to Fill or Clear
samples automatically (see 4.1.7).

Operating Manual
View
Switch between Layout and Factor (see 4.1.7)
Replicates
Is used to defined the number and orientation for the automatic
creation of replicated patient samples using the 'Fill' function (see
4.1.7)

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AUTOsOFT
5 Run a Test
As soon as Tests and related Layouts are programmed a Test can be run by selecting
[Reading] from main menu or clicking on the related icon.
! Please Note
After starting AUTOsoft and preparing the first test run as mentioned above by clicking
the related icon or selecting the menu option AUTOsoft automatically establishes
connection to the instrument connected and shows the message 'Instrument connected!'
in the status line at the bottom of the screen. Please make sure your instrument is turned
on and connected to the PC before clicking getting ready for a measurement.
The 'Start Test' window is opened which holds three tabs used to define the necessary
data for the Test and view the results.
Test Parameter – tab (see 5.1)
Sample IDs – tab (see 5.2)
Results – tab (see 5.3)
At the bottom of the Start Test window a number of buttons common to all tabs is
displayed.
[Start] Starts the Test after all settings have been performed. After the Test
run is finished the related result data is displayed.
If communication cannot be established to the instrument the
following message box is displayed:
In this case follow the instructions provided in the message displayed.

If the last test results have not been saved, the following message box
is displayed:
Click [Yes] to start the new test. Click [No] to cancel the test and wait
to save the last test results.

Operating Manual
5. Run a Test AUTOsOFT
[Recalculate] In case changes are done to the data or Test Parameters [Recalculate]
is used to update the results based on the changed values and
settings.
[Print] Prints a report in the selected format including all relevant data and if
applicable the standard graph.
By clicking on the small arrow symbol beside the [Print]-button the
two report format options 'Matrix Report' or 'Table Report' are
displayed and can be selected as required.
[Export] Exports the data displayed into a text file with a selectable name and
location.
[Save] Saves the current plate data and the sample results to the database
(see 5.5).
Additionally the related results are automatically exported to a file if
the 'Allow automatic export'-function is activated in Setup | Option |
Data Export (see 2.6.1)
[Exit] Returns to the AUTOsoft main screen.
5.1 Test Parameter –tab
Fig. 5-1: Start Test – Test Parameter

StartTest_TestParameter19.png
Test Parameter tab

Class of Tests Is used as a filter to only show the Tests assigned to a certain self
defined Class (see 2.6.2) or all 'Single Tests' or 'Multi Tests'
Saved Tests Select a previously programmed Test form the list which is shown
Select or create after clicking on the  Symbol beside the 'Saved Tests:'-label.

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AUTOsOFT
a Test The button […] beside the Saved Tests – label opens the 'Test
Definition' window in case the required Test is not yet available (see
4.1)
Please Note! Only Tests with a measurement method
corresponding to the type of instrument selected under Setup |
Instruments (as displayed in the headline of the main window) are
listed in the list of 'Saved Tests'.
Select or create If a default layout has been defined for the selected Test it is
a Layout automatically displayed in the field.
If the field is empty or if you want to use an alternative layout select a
previously programmed Layout from the list which is shown after
clicking on the  Symbol. The selected Layout is displayed in the
matrix.
The button […] beside the Saved Layouts – label opens the 'Layout
Definition' window in case the required Layout is not yet available
(see 4.1.4)
Alternatively, in case it doesn't make sense to store a specific Layout,
you may also create a Layout just for the individual Test run using the
layout controls available in the 'Start Test' window. The function is
identical to the normal Layout definition (see 4.1.4).
No. of samples Define the number of samples to be processed during the test run. If
the number entered exceed the number of available sample positions
in the layout, only the maximum number of samples is positioned.
Beginning No. Define the first sample number to be assigned. This parameter
automatically shows the next available Sample ID for the current day.
[Add sample ID Activate this feature if you want AUTOsoft to automatically assign
automatically] Sample IDs according to the two parameters defined above ('No. of
Samples' and 'Beginning No.').
Please Note!
If "Add sample ID automatically" is disabled patient samples can be
positioned anywhere on the plate – except for the special positions
assigned by the selected Layout!
[Virtual] Activate this feature if you want AUTOsoft to load data from a file
instead of performing a measurement on the instrument. The data
file to be loaded is defined in Setup | Instrument.
The data format for the related data file is a 12-columns / 8-lines
matrix with <TAB> separated entries. OD-values have to show 3
decimal places, RLUs are entered as values without decimal places.
During installation the sample data file DefaultData.txt is copied into
the installation directory and set as default file.
5.2 Sample IDs – tab

Sample IDs tab

Operating Manual
The Sample IDs tab is used to assign Sample IDs to the wells in the plate matrix.
If 'Add sample ID automatically' (in the bottom left corner of the Window) is enabled
AUTOsoft assigns the sample IDs as soon as the measurement is started.
The matrix shows all special positions assigned in the Plate Layout. All empty positions
can be used to position Sample IDs.
Please Note! The maximum length of a sample ID is 12 characters including the prefix.
Automatic (see Fig. 5-2)
is used to automatically assign Sample IDs
Generate Automatically positions sample IDs to the matrix according to the
parameters 'From' (first Sample ID) and 'To' (Number of Samples).
Clear Removes all previously assigned Sample IDs from the matrix
Prefix The prefix is the first section of the sample IDs automatically
generated. The maximum length of the prefix is 8 characters.
As default the current date is used as prefix (format: YYMMDD).
From Define the first sample number to be assigned. This parameter
automatically shows the next available Sample ID for the current day.
No. of samples Define the number of samples to be processed during the test run.
Samples (see Fig. 5-3)
is used to assign previously created/saved Sample IDs
As soon as the 'Samples' tab is activated the Sample ID window shows
a table of saved Sample IDs.
Select a Sample ID in the Sample ID table and click onto the desired
position in the matrix. The selected Sample ID is assigned to the
corresponding position and displayed there.
The Sample ID list can be sorted by clicking on the corresponding
column header.
The leftmost column shows the status indicator for the sample ID. A
green symbol indicates that results have already been assigned to the
sample ID. A red symbol is used for sample IDs which have only been
created but no results have been assigned so far. Accordingly newly
created Sample IDs can be grouped by sorting the list of sample IDs
by clicking on the header of the first column.
For details on the Sample ID list please refer to 6.1.
[…] In case new sample IDs have to be created during this step the […]-
Button opens the 'Samples' window.
After you have added the required Sample IDs click [Exit] and
AUTOsoft returns to the Sample ID tab.
[Clear] Removes all previously positioned sample IDs from the plate. Special
positions defined in the layout will remain on the plate.
[Fill->] If more than one Sample should be selected from the samples list and
positioned on the plate,
Select the desired Samples from the list (hold CTRL-key to select a
number of single Samples or SHIFT-key to select a number of Samples
as a block by defining the first and last sample in desired.
Click the [Fill->]-button to automatically fill the selected samples to
the plate. Use the 'Fill'-function rather than manual positioning
especially if the layout includes replicated samples.

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AUTOsOFT
Plates (see Fig. 5-4)
is used to assign sample IDs based on the sample IDs assigned to a
previously measured and saved plate. This feature is in particular
practical if a plate has to be measured a second time, if the same
plate should be measured and evaluated with an alternative test
method or if a second plate with the same layout and samples for
another diagnostic parameter has been prepared for measurement.
Select the plate ID of a previously measured plate from the table
displayed on the left side of the window and the sample IDs are
automatically positioned in the grid.
Please Note:
Make sure the plate layout of the plate the sample IDs are assigned to
is identical with the previously measured plate.
Advanced (see Fig. 5-5)
This function is related to preparing/performing a so called Kindling
test/experiment and assigns the sample IDs in a specific way so
individual results are created for repeatedly processed samples of the
same sample ID.
Normally repeated positioning of the same sample ID on the plate
would be considered as replicates and the mean value would be used
to calculate a single result for the sample ID. In case of a Kindling
Experiment a number of samples drawn under different patient
conditions are assigned to the same sample ID and processed
according to the same test parameters. The results however are
calculated for each specific sample individually and stored as
individual result in the sample database.
In order to use this feature activate [Kindling Test]
- Under 'Total' define the number of Samples (Sample IDs) to be
processed
- Under Repetitions define the number of different samples per
Sample ID.
- Under 'Kindling Sets' – 'First' to 'Fifth' (depending on the number of
desired repetitions) enter a label (text, time, etc.) describing the
condition the sample has been drawn under. In the Result View for
the saved Samples this label is appended to the TestName to
distinguish the individual condition (see picture below).

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Samples_Results_Kindling.png
Fig. 5-2: Start Test – Sample IDs – Automatic

StartTest_SampleID-Auto._19png

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Fig. 5-3: Start Test – Sample IDs – Samples

StartTest_SampleID-Samples19.png
Fig. 5-4: Start Test – Sample IDs – Plates

StartTest_SampleID-Plates19.png

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Fig. 5-5: Start Test – Sample IDs – Advanced

StartTest_SampleID-Advanced.png

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AUTOsOFT
5.3 Results – tab
After the measurement has been performed and AUTOsoft has performed the necessary
calculation the 'Results'-tab is automatically displayed to show all data related to the test
run. In the matrix view you can move the cursor over a position and the full value is
displayed (in case high values are displayed in scientific notation).
Fig. 5-6: Start Test – Results – OD

StartTest_Results-OD.png
Results – tab
RLU or OD Measurement results (see Fig. 5-6)
Change values or manually reject a value
If necessary the measurement value can either be altered by double-
clicking on the corresponding well and entering the desired value.
Alternatively a right mouse click will open a box showing two options
to be applied to the selected well:
'Modify Value': corresponds to a double-click on a well position. The
original value is displayed and can be altered
'Reject Well': the selected well is excluded from all further calculations.
Please Note!
In order to highlight the manual change the measurement-value (OD or
RLU) and all results calculated based on the changed value are
displayed and printed in italic letters! Rejected values are displayed in
strike through format. Changes and manual rejections applied to
measurement values are logged together with user, date and time. The
logged changes can be viewed under Tools | Log Viewer (see 7.7)
The high values which are displayed in scientific notation to fit into the
matrix can be viewed in total by moving the cursor into the

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corresponding field.
Qualitative The group indicators assigned to a samples according to the qualitative
evaluation defined in the test (empty if no qualitative evaluation is
performed).
If the programmed test makes use of the 'Titer Test' feature (see
4.1.7.1) the 'Qualitative-tab shows the Group Label of the relevant
sample (the last sample with the highest dilution still showing a
positive classification = classified in Group 2) at the relevant locations.
see Fig. 5-7
Concentra. The concentrations determined for a samples according to the
quantitative evaluation defined in the test (empty if no quantitative
evaluation is performed).
Titer Index If the programmed test makes use of the 'Titer Test' feature (see
4.1.7.1) the 'Concentration'-view is replaced by 'Titer Index'. The matrix
shows the Titer Indexes of each sample at the location of the relevant
sample (the last sample with the highest dilution still showing a
positive classification = classified in Group 2). All other positions are
left empty. In case no sample dilution shows a non-negative result the
corresponding position row1 will show '<X' (X corresponds to the Titer
Index of the lowest sample dilution) see Fig. 5-8.
Layout The layout used for the test run.
Sample ID The Sample IDs assigned to the wells within the plate matrix.
Graphics The standard curve calculated for the test run (see Fig. 5-9) (empty if
no quantitative evaluation is performed)
Mean Mean value of the Measurement result of replicated samples. If no
replicates are defined this screen displays like RLU. (Pick from list!)
Transform Results of the transformation.
If no transformation is defined this screen displays like RLU.
(select from list!)
Factor Factors assigned to the samples. (Pick from list!)
CV% Coefficient of variation between replicated samples.
If no replicates are defined this screen displays 0,00. (Pick from list!)
M/N Measurement value of the Sample divided by NC1 (Negative Control 1)
(Pick from list!)
M/CO Value of the Sample divided by Cutoff Value based on the selected
base (Meas. Value, Concentration or Transformation as selected from
the picklist in the 'Qualitative-tab see 4.1.3).
Status Shows the Status of each well measured and evaluated.
Normally all positions show 'OK' as Status.
'M-rejected': indicates a manually rejected positions
'Removed': If the programmed test makes use of the 'Titer Test' feature
(see 4.1.7.1) all positions except for the one meeting the criteria for
Titer determination show 'Removed' as status.
Parameter Shows details on the parameters calculated for the test.

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Fig. 5-7: Start Test (Titer Test) – Results – Qualitative

StartTest_Results_Qualitative-Titer.png
Fig. 5-8: Start Test (Titer Test) – Results – Titer Index

StartTest_Results_TiterIndex.png
Copy data to clipboard

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The data currently selected to be shown in the matrix and the Parameter-tab can be
copied to the clipboard by pressing CTRL-C and pasted into the desired application
(editor, spreadsheet, etc.).
Please Note: Before pressing CTRL-C you have to click a position in the matrix!
The first line in the copied data shows the related Test-ID, the second line data and time
of the measurement. The exported data is shown in 8-lines with 12 columns each with
TABs separating the individual data.
Fig. 5-9: Start Test – Results - Graphics

StartTest_Results-Graphics_19.png
5.4 Run test with a saved standard curve

As mentioned earlier AUTOsoft supports the use of saved standard curves (Reference
Curves) with quantitative evaluation. A Reference Curve is saved by activating the ''Save
as Ref. curve' option when saving the plate results by clicking [Save] after the test has
been run and evaluated (see 5.5).
The Reference Curve window can also be displayed independent of running a Test by
clicking Saved Plates | Reference Curve in main menu.
When performing a quantitative test AUTOsoft automatically verifies if the layout used
for the test incorporates the required standards. If no standards are available in the
layout or just one or two standards – instead of the number of standard points defined in
the test with assigned concentrations - AUTOsoft will automatically open the following
selection window showing all previously saved standard curves assigned to the same test.
In case of a Multitest the procedure is identical, except that the following procedure has
to be preformed for each individual test (meeting the criteria for using a saved standard
curve) on a Multiplate.

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AUTOsOFT
Fig. 5-10: Reference Curve selection

RefCurve_215..png
Name
Shows the list of all available, previously saved Reference Curves.
To select a curve left-click on it's list entry and the related curve
data will be displayed.
Please Note: The list of saved reference curves is automatically
filtered to only show saved curves which have been generated
with the same test.
Standards
X-Value Shows the concentration (X-Value) as defined in the test used to
Y-Value generate the curve and Y-Values - the measurement values (or
transformation value if a formula is defined).as determined during
the test run.
Curve + Corresponds to the entries in the 'Quantitative-tab during test
Axis (X/Y) definition (see 4.1.2)
Please Note: If the user logged on with AUTOsoft is 'admin' or a
'Super User' the values can be changed manually and the changes
can be saved. Changes applied to the values are only visualized in
the curve graph once the [Save]-button as been pressed.
[Save] Saves changes made to the Reference Curve data (see above) and
recalculates/updates the curve graph.
Graphics
Displays the standard curve graph of the selected Reference Curve.
Common Buttons
[New Curve] This button is used to create a new 'Reference Curve' with manually

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entered data. After clicking the button the following window is
displayed. As saved reference curves can only be used with the Test
they have been created with or they are assigned to please make
sure to select the related test from the list of 'Saved Tests'. The
selection 'Class of Tests' can optionally be used to reduce the
number of tests displayed for selection.
The 'Curve Name' can be freely defined. By default it is created in
the following format: TestName-YYMMDD-NN (YY=year,
MM=month, DD=day, NN=number counted for identical test
combinations).
After selecting the assigned Test and clicking [OK] the 'X-Value' list
in the 'Standards'-table is filled with the concentrations of the
assigned, previously selected 'Saved Test'. The axis of the graph are
displayed with the default labels for the X- and Y-axis.
Fill in the desired values in the 'Y-Value' list in the 'Standards'-table

corresponding to the individual concentrations. After clicking the
[Save]-button the corresponding curve is displayed.
In necessary the 'X-Values' (concentrations) can also be altered. The
changed concentration values of the Reference Curve will also be
used for evaluation (replacing the concentrations originally defined
in the Test). The concentration values of the assigned test will
however remain unchanged.
[Save] Saves the displayed Reference Curve
[OK] Closes the 'Reference Curve]-window and the selected Reference
Curve will be used for evaluation.
[Delete] Deletes selected Reference Curve from the list of available curves.
[Exit] Closes the 'Reference Curve' window discarding the selection and/or
any changes to the data or parameters.
After changes to the curve data or parameters the graph is only changed after the [Save]-
button has been clicked.
5.5 Save Results

After clicking the [Save] button the following window is displayed asking to enter some
information to stored together with the plate/sample data:
Info
Plate ID Enter the desired Plate ID used to identify the specific plate later
on in the list of saved plates and on the printed reports.
By default the plate ID is created automatically as following:

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AUTOsOFT
TestName-YYMMDD-NN
YY=year, MM=month; DD=day, NN=number of plate with the
same TestName and date.
Save as ref. curve Tick this box if the standard curve of the test should be stored and
made available as reference curve for Tests to be performed using
the same standard curve.
Please Note: Tests using a saved standard curve
If a test run should be performed using a saved reference curve
the same Test can be used without modification. AUTOsoft
automatically determines if the layout used for a test run
incorporates all standards defined in the 'Quantitative'-tab of the
test. If the layout includes no standards or only one or 2 standards
the user will be prompted to select a previously stored stand curve.
Depending on the number of standards present in the layout the
selected standard curve will either be used without adjustment (no
standards) or corrected based on one or two standards present in
the layout.
Curve Name By default the Curve Name is identical to the default format of the
Plate ID (see above)
Reagent
Name Pick a Reagent previously saved together with it's data under
'Directory' | Reagents
In case the Reagent has not yet been recorded click […] and the
Reagent-tab in the directory is opened so you can add or modify
the list and content of Reagents available for selection. After
clicking the [Exit]-button in the Reagent tab the program returns
to Save-window.
Batch Is filled in automatically with the 'Batch' recorded under the
selected 'Reagent'. The automatic entry can be altered manually.
Expiry date Is filled in automatically with the 'Expiry Date' recorded under the
selected 'Reagent'. The automatic entry can be altered manually.
Manufacturer Is filled in automatically with the 'Manufacturer' recorded under
the selected 'Reagent'. The automatic entry can be altered
manually.

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Fig. 5-11: Save Results without/with internal QC
StartTest_Save.png, StartTest_SaveQC.png
In case the layout of a test includes Controls (K1 to K6), a Cutoff in Qualitative evaluation
and QC-Project(s) have been defined under 'Internal QC' the right section of the 'Save'-
Window shows picklists to select the desired QC-Project the QC Data should be saved in.
If the Controls of the measured plate should not be saved select the empty position in
the picklist.
5.6 Run a Multitest

To run a Multitest, select Reading | Start Test and select the previously programmed
Mulititest under 'Saved Tests'.
Before starting the test the previously programmed and stored Layout can be altered by
selecting the 'Current Test' (right top corner of the Window) and the 'Type' of sample to
be positioned. The basic procedure is identical with defining a Multitest Layout (see 4.3).
Select the number of sample in 'No. of samples', click Start to run Mulititest (see Fig.
5-12).
In case 'Add sample ID automatically' is selected or the 'Generate'-button is clicked in the
'Sample IDs'-tab patient samples with the same number assigned in the layout will be
assigned the same Sample ID. If Sample IDs are assigned manually (Sample IDs |
Samples ) they have to be positioned individually across different test areas on the plate.
For details on how to position Samples please also refer to the section related to the
'Samples' in 5.2.
In case you don't want to use all tests assigned in the layout rightclick on the
corresponding column- or row headers to clear the related section of the layout until the
areas for the tests not required are cleared (the positions in the matrix will show a white
background). When positioning samples manually or automatically only the coloured
areas in the matrix must be filled with samples.

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AUTOsOFT
Fig. 5-12: Start Multitest
StartTest_Multitest_213.png
Fig. 5-13: Start Multitest

StartTest_Multitest_SampleIDs_213.png
The results of a Multitest are displayed corresponding to the colour code used in the
layout.
Fig. 5-14: Multitest Results

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StartTest_Multitest_Results_213.png
Saving Results of a Multitest

When the results of a Multitest are saved the procedure is similar to saving the results of
a Single Test (see 5.4). The data however has to be entered in a table with one line per
test in the Multitest and 11 columns to hold the data.
Fig. 5-15: Save results of a Multitest

StartTest_Multitest_Save1_213.png
Plate ID The Plate ID is created automatically according to the structure

defined according to the following structure:
TestName-YYMMDD-NN
YY=year, MM=month; DD=day, NN= number of plate with the
same TestName and date.
Reag. Name Doubleclick in the corresponding field. The list of Reagents saved
in the directory is displayed and the corresponding entry can be
selected.
Reag. Batch Automatically filled with the corresponding entries from the
Expiry Date Reagent (Reag. Name) selected above. The entries can be
Manufact. modified individually if necessary without updating the data
assigned to the Reagent in the Directory.
Save as Ref. curve By double-clicking into the corresponding filed of the table a
name to save the standard curve of the test is created based on a
default name structure (TestName-YYMMDD-NN … YY=year,
MM=month, DD=day, NN=Number). The name of the Reference
Curve Name can be changed manually if required.
K1 to K6 Is used to assign Controls (K1 to K6) to the corresponding 'QC
Serum' if the Control should be monitored in 'Internal QC' (see
7.1.1). After double-clicking in the corresponding field.
This feature only offers a selection of 'QC-Sera' if the Layout
incorporates Controls.

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AUTOsOFT
6 Saved Plates and Samples
The menu item 'Saved Plates' provides access to all previously measured and stored data
on a sample or plate level. Additionally previously saved reference curves to be used with
quantitative tests to be run later on can be viewed under this option.
6.1 Samples
The Samples-tab is used to:
 Add, modify and view detailed information to individual sample IDs
 Create new sample IDs with the related patient information
 Import sample IDs from a text file
 View Results for a selected sample ID
 Print result reports for selected Sample IDs
The Samples-tab offers all relevant information in one window separated into different
areas, which are described in the following chapter.
Left Area – Sample List

… is used to display the list of samples according to a defined 'Date Range' or a 'Search'
criteria based on some of the information saved together with the Sample ID. The data
assigned to the selected/highlighted Sample ID is automatically displayed in the Middle
and Right area of the Sample window.
Middle Area – Sample Information

… is used to display, add or modify all additional information saved together with the
selected Sample ID
Right Area – Sample Results

… displays the Results saved for the selected Sample ID. Results of external tests on the
same sample can added and altered. Result Reports over one or more selected samples
can be printed.

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6. Saved Plates and Samples AUTOsOFT
Fig. 6-1: Samples | Sample list, IDs, and Results

Samples_filled213.png
Date Range
From Select start date for the time interval to display Sample IDs.
To Select end date for the time interval to display Sample IDs.
[Refresh- Updates the Sample List according the 'Date Range' defined.
button]
Samples
Sample List 1st Column of the Sample List shows a symbol indicating if Test Results
are assigned to the Sample ID or not.
… no results assigned. Sample ID can be modified
… with results assigned. Sample ID cannot be modified
… results printed. Sample ID cannot be modified
2nd Column displays the Sample ID
3rd Column the Name of the Patient (last name, first name)
By clicking on the column header the displayed entries are sorted
according to the selected column. By sorting the first column
previously entered samples can easily be grouped together to select
them for positioning onto a plate.
Please Note: If the plate(s) containing the related result(s) of a sample
is/are deleted the related results are not available anymore.
Accordingly the results are not anymore displayed in the result list and
sample status indicator will turn red to show that no results are
available for the particular sample.

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AUTOsOFT
[Search] The [Search]-button opens
the window shown at the
left and offers the possibility
to define specific search
criteria to filter
corresponding samples.
Please Note: The search
criteria are only applied to
those samples which at the
same time also range within
the defined date limits (From
– To).
[Delete] …will delete the selected sample ID(s) and all Results related to it.
Sample IDs
Prefix Defines the prefix for the sample IDs to be used when generating new
sample IDs with [Batch Generate]
Beginning No.: Defines the first sample number to be created automatically using the
'Batch generate' function.
No. of Sample: Defines the number of Sample IDs to be created.
[Batch Creates Sample IDs according to the parameters defined above.
Generate] Please Note!
If the Sample IDs defined to be created already exist in the Sample ID
table the existing content is not overwritten!
Details
Sample ID By default AUTOsoft creates a Sample ID consisting of the current date
and the 4 digits sample number in the following format:
YYMMDD-XXXX
Name (l/f) Patient name last name / first name
Sex Sex of the Patient (pick from list)
Date of Birth Date of birth of the Patient
Blood Blood group of the Patient (pick from list)
ID Card ID Card number or Patient ID
Deliver Dr Name of Doctor who supplied the sample
Pick from list holding entries created in: Directory | Deliver Doctor
Sample Type Type of sample
Pick from list holding entries created in: Directory | Sample Type
Sec. Office Sec. Office
Pick from list holding entries created in: Directory | Section Office
Region Department within the hospital
Pick from list holding entries created in: Directory | Region
Bed No. Patients bed No.
Case No. Number of the patient file
Additional Other information according to your requirements
Deliver Date Sample delivery date (pick from calendar)

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Assessor Pick from list of configured AUTOsoft users (see 2.4).
Checker Pick from list of configured AUTOsoft users (see 2.4).
Remark Free remark on the Sample ID
[Add] The [Add]- button in the 'Sample Info'-area will add a new Sample-ID.
The following box is shown and will automatically display the next
available Sample ID.
Please Note: The settings for the prefix for batch generation of sample
IDs are not used to create the new sample ID but only the standard
structure!
Please Note: The new Sample ID is only created in the database if the
[Save]-button is clicked afterwards.
[Save] Will save all additions and alterations to the Sample Information.
You can alternatively press F2 to save the added or modified data.
Please Note: This [Add]-button will only save Sample ID data but not
changes to related results!
[Import] After clicking the [Import]-button the following window is displayed.
From File: is used to import a list of Sample IDs and related data from
an external text file.
Select the 'From File'-option and click on the […]-button to open a file
selection box. Select the file to import. Click [Start] to perform the
import of the Sample IDs which are then displayed in the 'Samples-
table.
If the file format is not correct a warning is displayed and the import is
cancelled. In this case please check the import file and correct it

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AUTOsOFT
accordingly.
Details on the format of the Sample ID import file are shown at the end
of this chapter.
When clicking the [Import]-button a file selection window is opened.
Select the desired file and click [Open]. The Sample ID data is imported
into the database and can be viewed in the 'Samples'-table.
From AutoLumo Data Path: is used to import a list of Sample IDs and
related data from AutoLumo.
Barcode or manual input: is used to record Sample IDs by barcode
scanner or manual input. If the message terminator (automatically sent
after a scan) is set to 'Enter', barcode labels with sample IDs can be
scanned subsequently without additional keyboard entry.
For manual input place the focus in the corresponding input field,
enter a Sample ID (4 to 16 characters long) and press the Enter-key to
transfer the entered Sample ID into the Sample ID table shown on right
side of the 'Sample Import' – window.
In order to remove Sample IDs from the table of IDs to be imported
select one or more Sample IDs in the table and click the [Delete]-
button.
After all sample IDs have been scanned or manually entered click [Start]
to transfer the previously scanned/entered Sample IDs into the
database. In case Sample IDs cannot be imported (e.g. due to invalid
length) the corresponding message will be displayed. Valid sample IDs
are imported and invalid Sample IDs will remain listed in the table.
[Exit] … terminates the sample Import function. Scanned/entered
Sample IDs which are still shown in the Sample table are discarded.
[Directory] Click the [Directory]-button to open the Directory and add new entries
without closing the Sample-tab. As soon as you have completed the
changes under 'Directory' click [Exit] in the Directory-tab and AUTOsoft
returns to the Sample-tab. The new entries are now available to pick
from the related lists.
Result Filter
From Select start date for the time interval to display Results for the selected
Sample ID.
To Select end date for the time interval to display Results for the selected
Sample ID.
Results The Result Table shows a summary of all Results available for the
selected Sample ID.
If multiple samples are selected in the 'Sample'-list the results list
shows the individual test results of all selected samples. In this case
the sample details for the first sample selected are displayed and
results can only be manually added to this sample.
Sample ID In case of a manually entered Result a '*' is displayed beside the
Sample ID.
Test Name … of the Test used to produce the Result
Result concentration incl. Unit and Qualitative Result (whatever is applicable).
Plate ID … of the Plate the sample was located on to give the related Result.

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In case a Result was added manually this field remains empty.
Details … displays all details on the result selected in the Results Table based
(Sample ID) on the Test used to perform the measurement and calculate the
related results. Alternatively if a manual result is added the general
information on the Test refers to the parameters stored for the
External Test under 'External Tests' in Setup | Directory (see 2.8)
E-Name … according to the General Test definition see 4.1.1
Print Index … according to the General Test definition see 4.1.1
Test Name … according to the General Test definition see 4.1.1
Qualitative Group assignment determined for the sample according to the
Qualitative Evaluation parameters (see 4.1.3 if applicable)
Conc. calculated for the sample according to the Quantitative Evaluation
parameters of the Test (see 4.1.2 if applicable)
Unit According to the unit selected in the Quantitative Evaluation
parameters of the Test (see 4.1.2 if applicable)
OD or RLU Depending on the instrument used for the Test (see 4.1.1)
M/CO Measurement Value / Cutoff according to the Qualitative Evaluation
parameters (see 4.1.3 if applicable)
Reference 1 to … as defined in the 'Reference'-tab in the Test Definition (see 4.1.6)
6
[Add] [Add] is used to add results to a patient ID which have not been
acquired using AUTOsoft and an instrument controlled by it but
supplied from another instrument or another lab.
To add a result to a selected Sample ID click [Add]. An empty list of
Result details is displayed which is enabled for manual entry. As soon
as all result data is entered click the [Save]-button and the added
Result is shown in the table of results for the selected Sample ID.
In case external tests have been saved in 'Setup | Directory | External
Tests' the picklist for 'E-Name' and 'Test Name' will offer these Tests for
selection and the corresponding fields will be filled with the previously
saved test data.
Added Results are marked with a '*' in front of the sample ID! (see the
second and third result line in Fig. 6-1).
Please Note:
Results added to sample IDs are logged together with user, date and
time. The logged changes can be viewed under Tools | Log Viewer
(see 7.7)
[Add] Batch In order to add the same panel of 'External Tests' to a number of
Add samples follow the steps described below:
- Select the desired samples from the list of Samples click on the
triangle beside the [Add]-button and . In order to select multiple
samples hold SHIFT and click the individual samples to be selected or
hold CTRL and select the last sample ID in the block of samples to be
selected.
- Click on the  symbol beside the [Add]-button and then on [Batch
Add]

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AUTOsOFT
- The following list showing all previously saved 'External Tests' (see
2.8) is displayed. Select the Tests that should be assigned to all
selected Samples and click [Save].
- The selected external test entries are added to the samples and the
results of all selected sample IDs are displayed in the Results list. This
step does not enter an actual result value but just create a result
entry with the information previously saved with the 'External Tests'.
- Select the previously added result entries one by one in the Results
List and fill in the specific values/results for the External Tests and
click [Save]. Proceed with the next added result entry.
[Delete] … will delete the selected Result.
[Save] Saves a newly added or modified Result.
For Results you can alternatively press F3 to save the modified data.
Please Note!
If you don't click [Save] before [EXIT] or selection of another Sample ID
your previously made changes will be discarded.
[Print] Prints the Result report on the selected samples. If multiple samples
are selected a separate Report will be printed for each Sample ID
selected including all Test Results related to the selected sample. For
an example see Fig. 10-1
[Exit] Exit 'Samples'. Return to Main Screen.
Format of the Sample ID import file

The Sample ID import file is a text file with <TAB> separating the different fields. The
format corresponds to the sample related information in the exported result information
under Tools | Data Export (see also 7.2). One headline with the column headers shown in
the table below are followed by one line of data per sample ID. Empty fields don't have
to show any data in the file but the <TAB>s corresponding to the related columns have
to be present. Except for the sample ID all fields are optional.
The following table shows the column headers in the Sample ID import file. 'Col.Letter'
corresponds to the column position in case the file is opened in a spreadsheet program.
Tip: The easiest way to create an import file is to perform an export as described in 7.2
and fill the existing file structure with new data. The easiest way to do this is in a
Spreadsheet.

Operating Manual
Col.No. Col.Letter Column Header Comment
1 A Sample ID Maximum length 16 characters
2 B Name 'LastName Firstname' (separated by a blank,
FirstName is optional) will be imported into
the corresponding Name fields.
3 C Sex Male or Female
4 D Birth Date DD.MM.YYYY
5 E ID Card Enter a string
6 F Blood Group Currently import is not supported but the
column has to be present
7 G Deliver Date DD.MM.YYYY
(time can be added but is not displayed)
8 H Assessor Currently import is not supported but the
9 I Sample Type Only use entries previously entered in the
'Directory'
10 J Deliver Doctor Currently import is not supported but the
11 K Section Office Currently import is not supported but the
12 L Bed No. Enter a string
13 M Region Only use entries previously entered in the
'Directory'
14 N Case No. Enter a string
15 O Additional Enter a string
16 P Checker Currently import is not supported but the
17 Q Remark Enter a string
Table 6-1: Column headers in Sample ID import file
The following data shows an example of the Sample ID import file. Only the first 10
columns of the headline including the column labels and one data set are displayed.
Sample ID Name Sex Birth Date ID Card Blood Group Deliver Date Assessor Sample Type Deliver Doctor …
ABCtest_001 Smith Sam Male 01.02.1960 ABC_001 A 18.05.2009 common Blood Jones …
….
6.2 Open Saved Plates

This option gives access to all previously measured plates.
When selecting 'Saved Plates'  'Open Saved Plates' form Main Menu or clicking on the
[Open]-icon the following window titled 'Open Saved Plates' is shown (see Fig. 6-2.)
The window offers two tabs:
Plates - tab
The 'Plates'-tab is divided into two sections:
Upper section
… lists all plates meeting the selected search criteria. All 3 criteria entered have to be met
in order to show a plate in the list.
Test Type Single: Only Single Test are listed
Multi: Only Multitest are listed

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AUTOsOFT
Date From: Start date of selected date interval
To: End date of selected date interval
Plate ID Is used to select saved plates by searching for the plate ID or a part of it.
Enter a sequence of characters and/or numbers (the search string) to
search for, click [Search] and the list is updated.
The search function is not case sensitive.
If the field 'Plate ID' remains empty this search criteria is not used!
[Search] Performs the search over all saved plates according to the data entered in
'Plate ID' (see above)
By clicking into a line in the table showing the plates the selected plate is displayed in the
Lower section of the Plates-tab.
Lower section
… shows a matrix view of the selected plate (or the related standard curve) and allows to
select the type of data displayed. The function of the lower section corresponds to the
'Result-tab' in the 'Start Test' window (for details see 5.3).
Fig. 6-2: Open Saved Pates | Plates

OpenSavedPLates_Plates.png
Change values or manually reject a value

If necessary the measurement value can either be altered in the OD/RLU view by double-
clicking on the corresponding well and entering the desired value. Alternatively a right
mouse click will open a box showing two options to be applied to the selected well:
'Modify Value': corresponds to a double-click on a well position. The original value is
displayed and can be altered
'Reject Well': the selected well is excluded form all further calculations.
Please Note!
In order to highlight the manual change the RLU-value and all results calculated based on

Operating Manual
the changed value are displayed and printed in italic letters! Rejected values are
displayed in strike through format. Changes applied to measurement values are logged
together with user, date and time. The logged changes can be viewed under Tools | Log
Viewer (see 7.7)
The high values which are displayed in scientific notation to fit into the matrix can be
viewed in total by moving the cursor into the corresponding field.
[Save] Saves the current plate data including possible manual changes to
the measurement data and the sample results to the database (see
5.4).
[Export] Exports the data currently displayed into a text file at with a
selectable name and location.
If the export is repeated for different data of the same plate and the
same file is selected for export the newly exported data will overwrite
the previous file.
[Delete] Deletes the currently selected plate / test data from the database.
Please Note: All data related to the plate will be deleted. Sample IDs
located on deleted plates are not deleted and remain available under
'Samples'. Sample Results on deleted plates however will be deleted.
QC-Data (see 7.1) generated from deleted plates is not deleted.
[Recalculate] In case changes are done to the data or Test Parameters [Recalculate]
is used to update the results based on the new values and settings.
Please Note: If the plate has been evaluated with a 'Reference Curve'
(saved standard curve) the Reference Curve selection window will be
automatically displayed after clicking [Recalculate]. You have to select
the required Reference Curve like if you have just run a test requiring
a saved Reference Curve (see 5.4)
[Print] Prints a report in the selected format including all relevant data and if
applicable the standard graph.
By clicking on the small arrow symbol beside the [Print]-button the
two report format options 'Matrix Report' or 'Table Report' are
displayed and can be selected as required.
[Exit] Returns to the AUTOsoft main screen.
Saving the Standard Curve of a saved plate

The data of the displayed standard curve can be saved as
'Reference Curve' for use with plates without or with
only one or two standards present on it. When the curve
is displayed perform a right click into the graphics area.

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Test Definition - tab
The 'Test Definition'-tab shows details on the Test used for the specific plate selected.
Fig. 6-3: Open Saved Pates | Test Definition

OpenSavedPLates_TestDef_32.png
The content and view of this tab is identical with the 'Test definition' window with it's
seven tabs (for details see 4.1).
Changes made to the Test Definition are only saved for the individual plate and do not
change the settings for the Test originally used to run the Test.

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7. Tools AUTOsOFT
7 Tools
The features accessible under Tools summarizes a number of functions related to the
export of data from the AUTOsoft database and database maintenance.
7.1 Internal QC
Internal QC is a function of AUTOsoft designed for quality control purposes in the
laboratory. It is used to monitor values obtained for controls which are defined in the
layout of a test and measured and evaluated in each test run.
Various criteria can be select to check the status of the controls (QC-Sera) based on a
series of previous measurements of the same QC-Sera under the same test conditions.
Additionally values for QC-sera can also be manually added or deleted.
A report function provides a printed protocol including all relevant data on a selected
QC-project.
Basic procedure
 Define a layout for a test (or a group of similar tests) including at least one control (K1
to K6) (see 4.1.7).
 Define a test using the layout created above. The test has to include qualitative
evaluation (also combined with quantitative evaluation) and the related Cutoff
definitions. Select the desired Cutoff Value definition to be used to calculate M/CO
(see 4.1.3).
 Define one or more 'QC Sera' representing the Controls in the QC calculations (see 0).
 Create one or more 'QC Projects' which define the method the results of the 'QC Sera'
is checked with, based on the results of a previous series of measurements of the
same 'QC Sera' (see 7.1.2).
 Run the previously defined test.
 When saving the results assign the corresponding, previously defined 'QC Project' to
the control(s) on the plate (K1 to K6). The data of the controls is automatically stored
as 'QC Data' to the selected QC Project and used to calculate the related limits for the
Rules based on mean value and standard deviation of M/CO (see above).
QC Data can also be added manually (see 7.1.3)
 By using the 'Print' Option (Settings | Print) the necessary QC protocols for each
project can be created (see 7.1.5).
The screen dump below shows an example for 'Internal QC'-main window with some data
of QC-sera previously assigned to the QC-Project 'Demo_K1'.

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AUTOsOFT
Fig. 7-1: Internal QC | Data | View Project

IntQC_QC-Main-Graph.png
Menu options in the 'Quality Control' window

Drawing Set Month to the latest month in which QC data was
recorded and redraw the displayed graph.
Data
QC Serum Manage and view QC-Serums (see 7.1.1)
View Project Manage and view QC-project settings based on
previously defined QC-Serums (see 7.1.2)
QC Data Manage and view QC-Data for previously defined
projects (see 7.1.3)
Setting
Initialize QC Data Removes all previous internal-QC entries from the
database (see 7.1.6)
Print Set options for Internal QC printouts (see 7.1.5)
Signing Set data on QC-operator, manager and date to be
printed on the QC-report (7.1.4)
Exit Closes 'Internal QC' and returns to main windows

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7. Tools AUTOsOFT
7.1.1 Define QC Sera (Data | QC Serum)
This option is used to define the QC-Sera together with the related information. Each QC
Serum represents a Control used in a test. Enter the required information and click [Add]
to create a new QC Serum.
Fig. 7-2: Internal QC | Data | QC Serum

IntQC_QC-Serum_197.png
No. * Can be freely assigned and is used to sort the table of QC-Sera
displayed in the related table.
Name Assign a name to a specific QC-Serum. This name is used to
identify/select the specific QC-Serum as 'QC Item' when defining the
QC-Project (see 7.1.2).
Batch Defines the Batch of the QC-Serum used (optional)
Source Defines the Source (e.g. Supplier/kit) the QC-Serum is sourced from
or linked to (optional)
Concentration Defines the Concentration of the QC-Serum if applicable (optional)
If the QC-Method is 'Real-time' and 'Class' is set to 'Quantitative' this
value is the target value for the concentration of the QC-Sera.
Unit Indicates the unit of 'Concentration' if a concentration is defined
(optional)
StdDev For Real-time method StdDev defines the acceptable standard
deviation for the concentration determined for the QC-Sera.
CV StdDev/Concentration is automatically calculated based on the
corresponding values entered above.
Upper Limit … for concentrations of QC-Sera to be acceptable (Real-time
Method)
= Concentration + StdDev (based on the values defined above)
Lower Limit … for concentrations of QC-Sera to be acceptable (Real-time
Method)
= Concentration - StdDev (based on the values defined above)

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AUTOsOFT
[Add] After all relevant entries defining a QC-Serum have been made click
[Add] to add the new entry to the table of QC-Serum.
[Delete] Removes the selected QC-Serum from the table/database.
Please Note: This will also delete the QC-Data collected so far in a
QC-Project using the deleted QC-Serum.
[Save] If an entry in an existing QC-Serum has been altered click [Save] to
save the changes to the database
[Close] Closes the QC-Serum Window and returns to the 'Quality Control'-
window.
7.1.2 Define QC Project (Data | View Project)

A QC-Project defines the criteria and Method applied to a sequence of measurements of
a QC-Serum (Control) to verify if the values obtained for a Control lie within a statistically
acceptable range.
The screen dump below shows an example of QC-Project parameter settings.

IntQC_Project_197.png
Details on the parameters to be set are described in the table below.

Details
Name Enter a name for the QC-project to be defined
Date Enter the date you want to use for the QC-project (e.g. starting date)
QC Serum Select the previously defined QC-Serum which should be monitored in the
QC-project.

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7. Tools AUTOsOFT
Method Instant Method
After the first two entries (which are marked 'Basic Data'), every entry is
checked to meet the selected rules until 20 entries have met the rules
(marked as 'acceptable'). The graph displays all following QC Values.
LJ Method
Uses the top 20 data as reference to calculate the mean and standard
deviation (and the limits for the rules accordingly) directly without
applying a check based on the rules selected.
After the 20 data sets are recorded the data for the all following QC-Sera
is displayed in the graph.
Real-time Method:
Observes if the value of a control lies within a acceptable range defined by
a target value and an acceptable standard deviation above and below the
target value.
Out of In the list of QC-projects each rule is represented by one digit of the 6
Rules digits number. '1' means the rule is applied, '0' the rule is not applied. This
entry is only updated after pressing [Save] if the rule selection has been
altered.
For details on the Rules please refer to the description and table below.
Class If 'Qualitative' is selected the M/CO-values (measurement value of the
corresponding control / CutOff-.value) will be observed
If 'Qualitative' is selected the concentration for the selected control will be
observed
[Add] After all relevant entries defining a QC-Project have been made click [Add]
to add the new entry to the table of QC-Projects.
[Delete] Removes the selected QC-Project from the table/database.
Please Note: This also removes all collected data on the related QC-project
form the database.
[Save] If an entry in an existing QC-Project has been altered click [Save] to save
the changes to the database
[Close] Closes the QC-Project Window and returns to the 'Quality Control'-
window.
Out of Rules
One or more of the following five QC criteria can be selected to check the value of the
QC-Serum selected under 'QC Item'. The criteria are either based on the mean value of the
20 previously measured controls (which proved to be within range) and the standard
deviation of this group of values or the tendency of the values (rising or falling).
Rule Description
one point is out of +-2s One point shows a value exceeding x (mean) ± 2s
four consecutive QC points fall Four consecutive QC point show values which all
on the same side outside of 1s exceed either x (mean) +1s or –1s (they are all
located on the same side of the mean value)
seven consecutive QC points are Seven consecutive QC points show a steady rising or
continuously rising or falling falling tendency.
two consecutive QC points The difference between 2 consecutive QC-points
differ by more than 4s exceeds ± 4s

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AUTOsOFT
seven consecutive QC points fall Seven consecutive QC points show values above or
on the same side of the mean below x (mean).
one QC point is out of 3s or two One point shows a value exceeding x (mean) ± 3s
consecutive QC points are out or two consecutive points show a value exceeding x
of 2s. (mean) ± 2s
7.1.3 View and add QC Data (Data | QC Data)

QC Data is used to view, add and change the data of QC Sera. Data from previously run
tests, containing controls which have been stored to the database together with the
regular test results after evaluation.
 The left-top screen dump is a sample for QC Data

in a project with 'Instant Method'. If a data status is
<Out of control>, it will be marked as invalid and
not be used to calculate the mean and standard
deviation (see line No. 8 marked by the arrow).
 The right-top screen dump shows a sample for
the LJ method. You can see the top 20 values are
used as Basic Data. They are not checked against the
criteria.
 The left-bottom screen dump shows a sample for

the Real-time method in quantitative mode.
Fig. 7-4: Internal QC | QC Data | Instant, LJ and Real-Time Method

IntQC_Data_Instant.png + IntQC_Data_LJ.png + IntQC_Data_RT.png
Project Name of the 'Project' selected (in the picklist) from the previously
defined projects.

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7. Tools AUTOsOFT
QC Serum The QC-Serum assigned to the selected project (see 7.1.2)
QC Method The Method defined in the selected project (see 7.1.2)
No Number of the data entry as shown in column 'No.' in the data table
M/CO M/CO = Measurement Value / Cutoff Value
or The Cutoff Value (of the Test) to be used in this calculation is defined in
Conc. the 'Qualitative'-tab of the Test Definition by selecting 'M/CO' for the
desired Cutoff (see 4.1.3.). 'M/CO' is shown if 'Class' is set to 'Qualitative'
in the related QC-project.
Conc. = The concentration for the monitored QC-Serum (Control)
determined during the test run. 'Conc.' is shown if 'Class' is set to
'Quantitative' in the related QC-project.
Status Basic Data: initial values in a QC project which are used to calculate the
mean and standard deviation for the QC-Project.
In 'Instant Method' 2 values are stored as 'Basic Data'
In 'LJ Method' 20 values are stored as 'Basic Data'
Acceptable: indicates that the value meets all selected 'Rules'
Out of control: indicates that the value doesn't meet one or more of the
Rules set in the QC-project.
Date The date the data has been added to the list of QC-data
OD Value The OD-value of the QC-serum in the individual test run.
Cutoff Value The value of the Cutoff in the individual test run. The Cutoff value is
obtained from the Cutoff selected in the test definition for the
calculation of M/CO.
[Insert] Inserts a new QC-data set with the data entered at the marked position.
[Add] Inserts a new QC-data set with the data entered at the end of the list.
[Save] If an entry in an existing QC-data set has been altered click [Save] to
save the changes to the database
[Delete] Removes the selected QC-data set
[Close] Closes the QC-Data Window and returns to the 'Quality Control'-
window.
Adding QC Data when saving test results

When saving the test results the right section of the 'Save'-Window shows picklist for
each Control used in the Test/Layout to select the desired QC-Project the QC Data should
be saved in. BY default the empty entry at the top of the picklist is selected.
The selection is only possible if the layout of the Test includes at least one Control (K1 to
K6), a Cutoff in Qualitative evaluation and QC-Project has been defined under 'Internal
QC'.

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Fig. 7-5: Select the 'QC Project ' to store QC data

StartTEst_SaveQC.png

IntQC_QC-Main-Graph.png
Project Name Name of the 'Project' selected

Month Is used to set a filter for the QC data to be displayed in the
Graph. Select 'All' or the Month to be displayed.
QC Method Shows the QC Method as defined in the selected QC Project. If
necessary the QC-Method can be changed temporarily and the
graph is automatically updated. The mode will however be set
back to the one selected in the QC-Project definition once this
window is closed or a different QC-project is selected.
QC Serum Shows the QC-Serum as selected in the definition of the selected

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7. Tools AUTOsOFT
QC-Project
Batch Shows the Batch defined in the QC-Serum
Date Shows the Date defined in the QC-Project
M/CO Mean M/CO Mean…over Measurement_Value / Cutoff_Value
or The Cutoff Value (of the Test) to be used as CO in this calculation
Conc. Mean is defined in the 'Qualitative'-tab of the Test Definition by
selecting 'M/CO' for the desired Cutoff (see 4.1.3.).
or
Conc. Mean…over Concentrations for the QC-Serum monitored
StdDev The Standard Deviation over the top 20 concentration values
which meet the selected rules.
CV The CV (Coefficient of Variation) over the top 20 M/CO values
which meet the selected rules (Standard Deviation / M/CO
Mean).
Diagram The diagram shows a graph of all QC Data after the first 20
points.
X-axis: Number of point and Date
Y-axis: M/CO value. The horizontal grid shows 'M/CO mean' of
the top 20 accepted values as 'x' and ± 1, ± 2 and ± 3s
7.1.4 Signing (Setting | Signing)

This option is used to define the additional information shown on the QC-report printout.
Fig. 7-7: Internal QC | Settings | Signing

IntQC_Settings_Signing.png
7.1.5 Print (Setting | Print)
Fig. 7-8: Internal QC | Settings | Print

IntQC_Settings_Print.png

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Output Mode:
Output Mode Description
Basic Data the top 20 correct data (see Fig. 7-9)
Monitoring Data the other data (see Fig. 7-10)
QC Graphics QC diagram (see Fig. 7-11)
Fig. 7-9: Internal QC | Printout | QC Basic Data (sample)

IntQC_Report_BasicData.png
Fig. 7-10: Internal QC | Printout | QC Monitoring Data (sample)

IntQC_Report_MonitoringData.png

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7. Tools AUTOsOFT
Fig. 7-11: Internal QC | Printout | QC-graphics (sample)

IntQC_Report_Graphics.png
7.1.6 Initialize QC Data (Setting | Initialize QC Data)

! Caution
This function is used to clear all previously defined and stored QC-data from your
database. Prior to doing this it is recommended to perform a backup of the database to
still keep the data accessible later if needed.
7.2 Export Data

This function is used to export sample based result data to a text file which can easily be
imported into other applications like a spreadsheet program or a database for further
processing.
The data exported for each Sample depends on the settings made under Setup | Option |
Data Export (see 2.6.1). By default all data fields are exported into the file.

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Fig. 7-12: Data Export – Select Plates

Export_Data_196.png
After starting the 'Export Data' function the above screen is displayed.
Date Range From: Start date of selected date interval
To: End date of selected date interval
[Refresh] After selecting the 'Date Range' you have to click the [Refresh]-button
to display the plates/samples meeting the 'Date Range'-criteria.
Saved Plates Displays the list of saved plates according to the selected date interval.
Select the IDs of the plate(s) you would like to have the sample/result
data exported for.
Path By default the path used to save the export data file is the installation
directory of AUTOsoft (e.g. C:\Program Files\Autobio\AUTOsoft\)
The default file name is automatically created in the format:
YYMMDDhhmm.txt (YY=year, MM=month, DD=day, hh=hour,
mm=minute corresponding to the time the Export Data function has
been ) started.
Data Table Shows the sample data according to the plate(s) selected under 'Saved
Plates'
[Export] Click the [Export]-button to export the selected data to the defined file
[Print] Prints a report of the selected plates/samples showing:
Sample ID, Name, Test, Result, RLU, M/CO
[Exit Click [Exit]to return to the main screen.
File format
First line: 'Autobio Co., LTDYYYY-MM-DD,hh:mm:ss'
YYYY=year, MM=month, DD=day, hh=hour, mm=minute, ss=second
Second line: Plate_ID (as assigned when the plate was saved)

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7. Tools AUTOsOFT
Third and following lines: The exported file shows a header line with the related column
headers as shown in the table below and according to the fields selected for export (see
above).
Each Sample ID and each Test is represented by one line in the exported file. This means,
if multiple tests have been performed for one Sample ID each result is shown in one line.
All entries are separated by TABs.
Empty fields show as '<--->'.
The following table shows the column headers in the exported file. 'Col.Letter'
corresponds to the column position in case the exported file (including all possible data)
is opened in a spreadsheet program.
Col.No. Col.Letter Column Header Col.No. Col.Letter Column Header
1 A Sample ID 17 Q Remark
2 B Name (last+first) 18 R Print Index
3 C Sex 19 S E-Name
4 D Birth Date 20 T Test Name
6 F ID Card 21 W Unit
5 E Blood Group 22 U Qualitative
7 N Deliver Date 23 V Concentration
8 O Assessor 24 X RLU/OD
9 H Sample Type 25 Y M/CO
10 G Deliver Doctor 26 Z Reference 1
11 I Section Office 27 AA Reference 2
12 K Bed No. 28 AB Reference 3
13 J Region 29 AC Reference 4
14 L Case No. 30 AD Reference 5
15 M Additional 31 AE Reference 6
16 P Checker
Table 7-1: Column headers in exported sample data file
7.3 Backup/Restore Database

In order to protect the valuable data stored in the AUTOsoft database it is strongly
recommended to regularly backup the database. In case of a computer problem like a
hard disk defect or if you want to use AUTOsoft on an other computer the database
backup can be used to restore the data available at the time the backup was done.
It is strongly recommended to store the backup on another computer or hard disk so it is
still available in case the computer or hard disk AUTOsoft is installed to is damaged.
! Please Note
Restoring a database backup will replace the existing database of the AUTOsoft
installation. Thus all data stored in the database prior to restoring it will be lost!
Backup database automatically

In order to automatically backup the database every time AUTOsoft is closed please
activate the function 'Backup database automatically'. Every time AUTOsoft is closed the
current database is saved to the location selected after clicking the 'Select Database Path'.
The filename of the saved database has the following format:
AutosoftYYMMDDhhmm.mdb
(YY=year, MM=month, DD=day, hh=hour, mm=minute)

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Fig. 7-13: Tools | Database Backup/Restore

Database_Backup-Restore_21.png
7.4 Repair Database

In case of a database related problem the 'Repair Database' option may be able to correct
the reason of the malfunction.
7.5 Compress Database

In order to maintain the performance of AUTOsoft related to database operations it is
recommended to perform the 'Compress Database' operation regularly.
7.6 Initialize Database

This function is used to remove selected parts of the data in the AUTOsoft database. If all
types of data are selected the database will be reset to it's initial status.
Fig. 7-14: Tools | Inizialize Database

Tools_Init-Database.png

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7. Tools AUTOsOFT
7.7 Log Viewer
The Log Viewer is used to display information collected for:
 Measurement results manually modified in the RLU view after a test run or in a
previously saved, opened plate (see 'Wells').
 External test results manually added to or removed from a Sample ID (see 'Results').
The Log Viewer Window offers a selection of the 'Date Range' for the logged information
to be displayed.
Please Note:
The date selection is not used to filter the Plate- or Sample IDs but only the date the
change or addition was carried out!
Please Note:
Only the user 'admin' or a user assigned to the 'super level'-group can open the Log-
viewer!
Wells
Shows data on manual changes applied to measurement results in the RLU-view.
Operator … logged on during the change was performed
Plate ID … the Sample ID is located on, for which the RLU value was
changed.
Sample ID … for which the RLU value was changed.
Old Value OD/RLU value prior to the manual change
New Value OD/RLU value after the manual change or
'M-reject' to indicate that the value has been manually rejected.
Date Date and time to change has been performed
Fig. 7-15: Tools | Log Viewer - Wells

Tools_LogViewer_Wells.png

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Results
Shows data on results manually added or removed to a Sample ID (see also 6.1 – [Add]).
Operator … logged on during the change was performed
Sample ID … the Result was added to
Test Name … as entered in the field 'Test Name' in the Samples | Results – tab
Operation Shows the operation applied:
'Add external result' or
'Delete external result' or
'Delete result'
Date Date and time to change has been performed
Fig. 7-16: Tools | Log Viewer - Wells

Tools_LogViewer_Results.png
Please Note:
If the ‘Sample ID’ shows empty, it is shown that the saved plate is deleted, and the ‘Test
Name’ is the saved plate.

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8. Measurements without evaluation AUTOsOFT
8 Measurements without evaluation
8.1 Quick Test
The Quick Test option is used to perform a measurement without subsequent evaluation
of the measurement data.
The following screen-shot shows and example for the Quick-Test Results-tab after a
measurement has been performed. The result data remains displayed until the next
measurement is performed by clicking [Start] or the 'Quick Test'-window is closed.
1. Select the desired measurement parameters depending on the measurement mode
selected.
2. Select the well positions to be measured by either activating the individual well
positions in the matrix one by one with a left-click (a right click will deactivate the
position) or by column or row by a left-click on the column- or row indicator or by
activating all well positions by clicking the [ALL Wells]-button.
3. Click the [Start]-button to perform the defined measurement.
4. View, print or export the data.
Fig. 8-1: Quick Test – Results-tab

QuickTest_Results.png
The individual features of the Quick Test function are described in the table below:
Luminescence Depending on the type of instrument selected the corresponding
or measurement function is activated and the non valid option is
Photometric disabled.

Operating Manual
AUTOsOFT
Meas.Filter(nm) If 'Photometric' is selected as measurement method the desired
and wavelengths have to be selected. If a dual wavelength measurement
Ref.Filter(nm) should be performed 'Ref.Filter(nm)' has to be selected, otherwise
'Ref.Filter(nm)' has to be set to '<-->'.
Meas.Time If 'Luminescence' is selected as measurement method the desired
(x0.1sec): integration time has to be set in multiples or 0.1sec (e.g. 10 = 1
second)
Enable Shaking Enable Shaking function
Intensity Set intensity of Shaking if enabled
Time Set time of Shaking if enabled
[ALL Wells] Selects all well positions on the plate to be measured in the 'Select
Wells'-tab.
[Clear] Clears all previously selected positions on the plate to be measured in
the 'Select Wells'-tab.
[Start] Starts the measurement on the connected instrument, transfers the
data to the PC and displays the measurement data in the 'Results'-tab
[Print] A matrix format printout is produced including basic measurement
information.
[Export] Exports the measurement data including the status data to a selected
file. If the file already exists the newly exported data is added at the
end of the file. The measurement and status data is provided in tab-
separated matrix format which can be imported or pasted into a
spreadsheet.
The data format is shown in Appendix 3.
[Exit] Exits the Quick Test Window.
Ctrl-C Copies the data displayed in the matrix into the clipboard in 8x12
format with TABs separating the values. The header section consists of
an entry ' Quick Test Results' in the first line and the data and time in
the second line.
8.2 Scan measurement

The Scan feature available through 'Reading | Scan' provides access to the scan
measurement function of PHOmo. It can perform a measurement at a desired
wavelength, display the calculated OD value per well, graphs of the scan profile through
the wells and offers an export option to transfer the OD and scan data into a text file for
further external calculation.
Filter Select the filter to be used for the measurement from the list of filters
listed in the drop down list.
[Start Test] Start the measurement. After the measurement the full set of scan data
and the calculated OD values for each well is transferred to the PC and
displayed as graph in the 'Graph'-window and as single OD values per well
in the data matrix. (see Fig. 8-2)
By clicking onto a well position in the matrix the scan data of the well

Operating Manual
8. Measurements without evaluation AUTOsOFT
position will be displayed as graph.
By clicking into the graph it will be enlarged to fill the scan window. By
clicking into the enlarged graph the display will return to split view with
graph and matrix. (see Fig. 8-3)
[Export] Exports the data to a text file with 2 sections:
1. OD value per well
2. Scan data as 29 transmittance values per well with a well position
indicator in the beginning of the line.
For details on the data format of the file refer to Appendix 2
Fig. 8-2: Scan Measurement combined view

Scan_gridview.png

Operating Manual
AUTOsOFT
Fig. 8-3: Scan Measurement scan curve view

Scan_curveview.png

Operating Manual
9. Example of use AUTOsOFT
9 Example of use
9.1 Defining and Running the Tests
Prior to running a test the Test and the Layout must be defined. Once defined Tests and
Layouts are stored in AUTOsoft and can be selected for an individual test run.
As an example the steps necessary to set up the Autobio AFP-kit in AUTOsoft are
described.
The following text extract is taken from the package insert that comes with the Autobio
AFP-kit.
Extract from working instructions for Autobio AFP kit:

Reagent Preparation
1. All reagents should be brought to room temperature (18-25°C) prior to use. All
reagents should be mixed by gently inverting or swirling prior to use. Do not
induce foaming.
2. Reconstitute each lyophilized standard with 0.5 ml distilled water. Allow the
reconstituted material to stand for at least 10 minutes. Reconstituted standards
should be stored sealed at 2-8°C. Reconstituted standards should be used within
14 days and be frozen at -20°C for long term storage.
3. To prepare CLIA substrate: gently mix the substrate A and substrate B in the
proportion of 1:1 60 minutes before use. The prepared CLIA substrate solution
(after mixing) is stable at room temperature, in the dark, for 12 hours. Discard
excess after use.
4. Secure the desired number of coated wells in the holder.
Dispense 20µl of AFP standards, specimens, and controls into appropriate wells.
5. Dispense 100µl of enzyme conjugate reagent to each well. Mix gently for 30
seconds.
6. Incubate at 37°C for 60 minutes.
Prepare CLIA substrate 60 minutes before use.
7. At the end of the incubation, remove the incubation mixture by emptying the
plate content into a waste container. Rinse and empty the microtiter plate 5 times
with distilled water. Strike the microtiter plate sharply onto absorbent paper or
paper towels to remove all residual water droplets. The volume of the well is
about 300µl.
8. Dispense 100µl of the prepared CLIA substrate reagent into each well. Gently mix
for 10 seconds.
9. Incubate at room temperature in the dark for 5 minutes without shaking and read
the RLU values with a Luminometer.

Operating Manual
AUTOsOFT
Calculation of Results
Construct a standard curve by plotting the RLU obtained from each reference standard
against its concentration in ng per ml on logarithmic graph paper, with RLU values on
the vertical or Y-axis and concentrations on the horizontal or X-axis. Use the RLU values
for each specimen to determine the corresponding concentration of AFP in ng per ml
from the standard curve. Any diluted specimens must be corrected by the appropriate
dilution factor.
Expected Values and Sensitivity
In high-risk patients, AFP values between 20 and 400ng/ml indicate the disease, and
levels over 400 ng/ml usually suggest a diagnosis of hepatocellular carcinoma.
Approximately 97% of the healthy subjects have AFP levels less than 20 ng/ml. It is
recommended that each laboratory establish its own normal range. The minimum
detectable concentration of AFP by this assay is estimated to be 1.0ng/ml.
Table 9-1: Extract from working instructions Autobio AFP-kit
9.1.1 Tests Definition

From the Tests Definition menu, select Single Test.
Test Definition appears (see Fig. 9-1).
Fig. 9-1: Signal Test Definition

EX_TestDef.png
Choose General, click New.

1. Follow the instructions, enter AFP. Choose [OK].
2. Select the corresponding Classs and SubClass(Child) entries that AFP is assigned
to.
3. In E-Name, enter AFP (see Fig. 9-1).
4. In Mode, select Quantitative

Operating Manual
5. In Meas. Parameter, select Lumo
6. Choose Quantitative. In Units, enter ng/ml.
7. In Extrapolation, select up.
8. In Curve, select Point to Point
9. In Axis（X/Y）,select Log/Log.
10. Define concentrations for standards (see Fig. 9-2)
In S1, enter 10
In S2, enter 20
In S3, enter 50
In S4, enter 100
In S5, enter 250
In S6, enter 500
11. In 1 of Reference, enter <20ng/ml.
12. Click Save, Save current test successfully appears. Click OK to save the test.
Fig. 9-2: Quantitative Definition

EX_TestDef_QNT.png

Operating Manual
AUTOsOFT
9.1.2 Layout Definition
From the Test Definition menu, select Layout Definition (see Fig. 9-3).
Fig. 9-3: Layout Definition

EX_LayoutDefinition1.png
Click New, define the following information.

1. Enter AFP, click OK.
2. In Type, select S (for Standard). Then setup six standards in A1,B1,C1,D1,E1 and
F1(see Fig. 9-4).
Fig. 9-4: Layout of Sandards

3. In Filling Direction, select Vertical.

Choose Save, Save current layout successfully appears.
Click OK to save the layout (see Fig. 9-5).

Operating Manual
Fig. 9-5: Layout of samples

9.1.3 Performing Measurement

From the Reading menu, select Start Test. Start Test appears (see Fig. 9-6).
Fig. 9-6: Start Test

EX_StartTest.png
In [Class of Tests], select the Class, In [Saved Tests], select the test. In [Saved Layouts],
select the layout (see Fig. 9-7).

Operating Manual
AUTOsOFT
Fig. 9-7: Select the Test and Layout

EX_StartTest_Layout.png
From Start Test, choose NO. Sample IDs, enter the number of sample (for example,8).
Then click Generate (see Fig. 9-8).
Fig. 9-8: Choose NO. Sample IDs

EX_StartTest_SampIeID.png

Operating Manual
Choose Start, Start Test appears. Select Yes. Test Results appears when the measurement
is over (see Fig. 9-9).
Fig. 9-9: Test Results RLU

EX_StartTest_Res_RLU.png
In the example above all values are Measured in virtual mode.

Now the Raw Data (RLUs) of the measurement results is displayed. If you select Conc..,
the concentration of samples will be displayed (see Fig. 9-10).

Operating Manual
AUTOsOFT
Fig. 9-10: Concentration of Samples
EX_StartTest_Res_Conc.png
Choose Graphics to display the graphic of standards (see Fig. 9-11).
Fig. 9-11: Graphic of a standard curve

EX_StatTest_Res_Graphics.png
Choose Save.
The ‘Save’ Window is
displayed
Click to select the name of

reagent in the Reagent (the
name of reagent is entered in
the 'Directory', see 2.8. The
Batch, Expiry date and
Manufacturer displays at the
same time (see Fig. 9-12).
Fig. 9-12: Save measured test

EX_SavePlate.png
Click OK to Save and Exit.
9.2 Viewing and Printing

A．Printing Matrix
From Saved Plate, select Open Saved Plate. Open Saved Plates appears (see Fig. 9-13).

Operating Manual
Fig. 9-13: Open Saved Plates

EX_OpenSavenPlates.png
Choose Print Matrix to print the measurement result by printer in matrix.
B. Printing Assay
From Saved Plate, select Samples. Samples appears (see Fig. 9-14).
Fig. 9-14: Printing Assay

You can press the Ctrl-key and select samples which you want to print. Then click Print.
The assay can be printed.

Operating Manual
AUTOsOFT
Enter Sample Information
For how to enter sample information please refer to the instructions given in chapter 6.1.

Operating Manual
10. Appendix AUTOsOFT
10 Appendix
Appendix 1. Printout examples ......................................................................... 116
Appendix 2. Scan data export format ............................................................... 120
Appendix 3. Quick Test export format .............................................................. 121
Appendix 4. List of tables and graphics ............................................................ 122

Operating Manual
AUTOsOFT
Appendix 1. Printout examples
Fig. 10-1: Report - Sample

Report_Sample.png

Operating Manual
Fig. 10-2: Report – Matrix Quanitative Test 1/2

Report_Matrix_QNT_1_231.png

Operating Manual
AUTOsOFT
Fig. 10-3: Report – Matrix Quanitative Test 2/2

Report_Matrix_QNT_2_231.png

Operating Manual
Fig. 10-4: Report – Table (example)

Report_Table_231.png

Operating Manual
AUTOsOFT
Appendix 2. Scan data export format
The following data shows an example of exported data from a scan measurement on
PHOmo hich could be used for import into Excel or any other calculation program.
The header section (line 1 to 3) provides general information on the measurement
'OD-Values' indicates the beginning of the section showing the OD values calculated for
each well as displayed during a normal measurement. The OD values are presented in
8x12 matrix format an separated by tabs.
'Scan Data' indicates the beginning of the scan data section.
The data of each well is each well is shown in one line starting with the well-position
indicator in the format 'Cell ROW,COLUMN' followed by 29 transmittance values in the
range of 0 to 1 (very small negative values are possible when measuring through air). The
well-position indicator and the 29 values are separated by tabs.
PHOMO Test
Fitler: 405nm
03.08.2015 12:41:48
OD Values
0,002 0,000 4,500 0,154 0,27 0,385 1,361 2,639 3,903 0,001 4,500 0,002
0,003 0,000 4,500 0,154 0,271 0,384 1,356 2,63 3,727 4,500 0,001 0,004
0,003 0,000 4,500 0,152 0,269 0,383 1,355 2,627 3,692 0,001 4,500 0,004
0,002 0,000 4,500 0,154 0,271 0,386 1,359 2,627 3,727 4,500 0,001 0,003
0,002 0,000 4,500 0,153 0,269 0,384 1,354 2,636 3,852 0,001 4,500 0,002
0,002 0,000 4,500 0,157 0,274 0,390 1,362 2,645 3,806 4,500 0,001 0,002
0,002 0,000 4,500 0,158 0,274 0,390 1,362 2,633 3,806 0,002 4,500 0,002
0,002 0,000 4,500 0,154 0,268 0,384 1,356 2,636 3,765 4,500 0,001 0,003
Scan Data
Cell 1,1 -0,000039 -0,00002 0 0,000098 0,000938 0,010493 0,067237 0,284698 0,619126 0,862946 0,955331 0,984798
0,993239 0,995779 0,996444 0,996287 0,994412 0,967876 0,787678 0,41546 0,149813 0,050726 0,016394 0,004729
0,001466 0,000469 0,000156 -0,00002 -0,000098
Cell 1,2 0,999629 0,999629 0,999668 0,99959 0,999629 0,999629 0,999629 0,99959 0,99955 0,999629 0,999648 0,99959
0,999629 0,99959 0,999629 0,99959 0,99959 0,999511 0,99955 0,99955 0,999511 0,999511 0,99955 0,999453
0,99955 0,999472 0,999472 0,999472 0,999492
Cell 1,3 0 -0,000059 0,000039 0,000117 0,00002 -0,000059 -0,00002 0,00002 -0,00002 0,000039 0,00002 -0,00002
-0,000117 -0,00002 0 0,000059 -0,00002 -0,00002 -0,000078 0,00002 0 0,000039 -0,000059 -0,00002
-0,00002 0,000059 -0,000039 -0,00002 0,00002
...
...
...
Cell 8,10 0,000019 -0,000058 -0,000214 -0,000253 -0,000214 -0,000292 -0,000253 -0,000214 -0,000312 -0,000214 -0,000253 -0,000253
-0,000253 -0,000214 -0,000273 -0,000234 -0,000234 -0,000195 -0,000312 -0,000214 -0,000292 -0,000312 -0,000273 -0,000292
-0,000292 -0,000195 -0,000019 -0,000058 -0,000019
Cell 8,11 0,010198 0,086653 0,327347 0,697709 0,899542 0,966501 0,986078 0,992668 0,994852 0,995944 0,996276 0,996529
0,99651 0,996646 0,996568 0,996646 0,996588 0,996568 0,996451 0,996256 0,995788 0,995262 0,99454 0,993468
0,984791 0,860427 0,52803 0,210471 0,069669
Cell 8,12 0,00002 0,000117 0,000078 0,000176 0,000585 0,004057 0,023894 0,138663 0,426582 0,754993 0,922642 0,973414
0,989604 0,994324 0,995767 0,995884 0,995338 0,989994 0,896524 0,590661 0,256924 0,090934 0,02879 0,009109
0,002789 0,000819 0,000254 0,000117 -0,000078

Operating Manual
Appendix 3. Quick Test export format
The following data shows an example of exported data from a Quick Test measurement
on PHOmo which can be used for import into Excel or any other calculation program. The
individual values are separated by TABs.
Quick Test Results

25.08.2015 16:14:36
OD:
-------
0,049 1,466 0,709 1,375 1,069 0,931 0,165 0,874 0,953 1,474 0,954 1,117
0,046 1,483 0,702 1,394 1,085 0,946 0,177 0,879 0,973 1,481 0,960 1,121
0,374 0,418 0,834 0,758 0,206 1,439 1,360 1,263 0,666 1,027 1,448 0,374
0,359 0,912 0,860 0,764 0,208 1,462 1,354 1,295 0,677 1,057 1,482 0,382
0,582 0,731 1,233 0,653 1,024 1,176 0,386 1,205 1,474 1,017 1,321 1,275
0,592 0,748 1,275 0,653 1,018 1,181 0,408 1,225 1,500 1,047 1,315 1,308
0,933 0,229 0,346 0,730 1,465 0,417 0,232 0,476 0,857 0,665 1,364 1,257
0,915 0,225 0,356 0,771 1,505 0,439 0,240 0,479 0,881 0,667 1,394 1,264
Status:
-------
OK OK OK OK OK OK OK OK OK OK OK OK

Operating Manual
AUTOsOFT
Appendix 4. List of tables and graphics
Tables
Table 2-1: AUTOsoft software system requirements .................................................................................... 3
Table 2-2: Disabling Windows Vista 'User Account Control' UAC .................................................................. 4
Table 2-3: Installing AUTOsoft – steps for setup .......................................................................................... 4
Table 2-4: License information for AUTOsoft (example) ............................................................................... 8
Table 2-5: Rights of different users / user types ........................................................................................... 9
Table 2-6: Setup Instrument Dialog ........................................................................................................... 16
Table 3-1: Menu Bar ................................................................................................................................. 24
Table 3-2: Tool Bar.................................................................................................................................... 25
Table 4-1: Test Definition Parameters – General ........................................................................................ 30
Table 4-2: Test Definition Parameters - Quantitative .................................................................................. 33
Table 4-3: Test Definition Parameters – Qualitative.................................................................................... 34
Table 4-4: Test Definition Parameters - Validation ..................................................................................... 36
Table 4-5: Test Definition Parameters - Shaking......................................................................................... 37
Table 4-6: Test Definition Parameters - Reference ...................................................................................... 38
Table 4-7: Titer determination example ..................................................................................................... 41
Table 4-8: Content of the first worksheet in the evaluation workbook....................................................... 44
Table 4-9: Test settings for external evaluation ......................................................................................... 45
Table 4-10: Files to be used as example for external evaluation ................................................................... 46
Table 4-11: Layout Definition ...................................................................................................................... 51
Table 6-1: Column headers in Sample ID import file .................................................................................. 81
Table 7-1: Column headers in exported sample data file ........................................................................... 97
Table 9-1: Extract from working instructions Autobio AFP-kit .................................................................. 106
Graphics
Fig. 2-1: Select USB Serial Port in the Device Manager .............................................................................. 5
Fig. 2-2: Restore Default Settings for USB Serial Port ................................................................................ 6
Fig. 2-3: Modify Advanced Settings for USB Serial Port ............................................................................. 6
Fig. 2-4: AUTOsoft desktop icon ............................................................................................................... 7
Fig. 2-5: License (example) ....................................................................................................................... 7
Fig. 2-6: Login admin ............................................................................................................................... 8
Fig. 2-7: Change Password ....................................................................................................................... 8
Fig. 2-8: Add New User ............................................................................................................................ 9
Fig. 2-9: Setup | Options | Data Export .................................................................................................. 11
Fig. 2-10: Setup | Options | Item Classification ........................................................................................ 12
Fig. 2-11: Setup | Options | Others .......................................................................................................... 13
Fig. 2-12: Setup | Options | Sample Info.................................................................................................. 14
Fig. 2-13: Directory | Section Office ......................................................................................................... 17
Fig. 2-14: Directory | Region .................................................................................................................... 18
Fig. 2-15: Directory | Deliver Doctor ......................................................................................................... 18
Fig. 2-16: Directory | Sample Type ........................................................................................................... 19
Fig. 2-17: Directory | Unit ........................................................................................................................ 19
Fig. 2-18: Directory | Remark ................................................................................................................... 19
Fig. 2-19: Directory | Reagent .................................................................................................................. 20
Fig. 2-20: Directory | External Tests .......................................................................................................... 21
Fig. 3-1: Main Window .......................................................................................................................... 22
Fig. 4-1: Test Definition General ............................................................................................................. 27

Operating Manual
Fig. 4-2: Test Definition Quantitative ...................................................................................................... 31
Fig. 4-3: Test Definition Qualitative ........................................................................................................ 33
Fig. 4-4: Test Definition Validation ......................................................................................................... 35
Fig. 4-5: Test Definition Shaking ............................................................................................................. 37
Fig. 4-6: Test Definition Reference .......................................................................................................... 38
Fig. 4-7: Layout definition with 8 replicates for Titer Evaluation (example) ............................................. 39
Fig. 4-8: Factor Definition for Titer Evaluation ........................................................................................ 40
Fig. 4-9: External Evaluation – 1st worksheet.......................................................................................... 44
Fig. 4-10: Test Definition | Advanced | Variables ..................................................................................... 47
Fig. 4-11: Layout Difinition ....................................................................................................................... 49
Fig. 4-12: Multitest Definition .................................................................................................................. 52
Fig. 4-13: Select test................................................................................................................................. 53
Fig. 4-14: Multitest – Layout Definition .................................................................................................... 54
Fig. 5-1: Start Test – Test Parameter ....................................................................................................... 57
Fig. 5-2: Start Test – Sample IDs – Automatic ......................................................................................... 61
Fig. 5-3: Start Test – Sample IDs – Samples ............................................................................................. 62
Fig. 5-4: Start Test – Sample IDs – Plates................................................................................................. 62
Fig. 5-5: Start Test – Sample IDs – Advanced .......................................................................................... 63
Fig. 5-6: Start Test – Results – OD ........................................................................................................... 64
Fig. 5-7: Start Test (Titer Test) – Results – Qualitative .............................................................................. 66
Fig. 5-8: Start Test (Titer Test) – Results – Titer Index .............................................................................. 66
Fig. 5-9: Start Test – Results - Graphics ................................................................................................... 67
Fig. 5-10: Reference Curve selection ......................................................................................................... 68
Fig. 5-11: Save Results without/with internal QC ...................................................................................... 71
Fig. 5-12: Start Multitest .......................................................................................................................... 72
Fig. 5-13: Start Multitest .......................................................................................................................... 72
Fig. 5-14: Multitest Results ....................................................................................................................... 72
Fig. 5-15: Save results of a Multitest......................................................................................................... 73
Fig. 6-1: Samples | Sample list, IDs, and Results ..................................................................................... 75
Fig. 6-2: Open Saved Pates | Plates ........................................................................................................ 82
Fig. 6-3: Open Saved Pates | Test Definition ........................................................................................... 84
Fig. 7-1: Internal QC | Data | View Project ............................................................................................. 86
Fig. 7-2: Internal QC | Data | QC Serum ................................................................................................. 87
Fig. 7-4: Internal QC | QC Data | Instant, LJ and Real-Time Method ....................................................... 90
Fig. 7-5: Select the 'QC Project ' to store QC data .................................................................................... 92
Fig. 7-7: Internal QC | Settings | Signing................................................................................................ 93
Fig. 7-8: Internal QC | Settings | Print .................................................................................................... 93
Fig. 7-9: Internal QC | Printout | QC Basic Data (sample) ....................................................................... 94
Fig. 7-10: Internal QC | Printout | QC Monitoring Data (sample) .............................................................. 94
Fig. 7-11: Internal QC | Printout | QC-graphics (sample) .......................................................................... 95
Fig. 7-12: Data Export – Select Plates ....................................................................................................... 96
Fig. 7-13: Tools | Database Backup/Restore .............................................................................................. 98
Fig. 7-14: Tools | Inizialize Database ........................................................................................................ 98
Fig. 7-15: Tools | Log Viewer - Wells ........................................................................................................ 99
Fig. 7-16: Tools | Log Viewer - Wells ...................................................................................................... 100
Fig. 8-1: Quick Test – Results-tab .......................................................................................................... 101
Fig. 8-2: Scan Measurement combined view......................................................................................... 103
Fig. 8-3: Scan Measurement scan curve view ........................................................................................ 104
Fig. 9-1: Signal Test Definition .............................................................................................................. 106

Operating Manual
AUTOsOFT
Fig. 9-2: Quantitative Definition ........................................................................................................... 107
Fig. 9-3: Layout Definition .................................................................................................................... 108
Fig. 9-4: Layout of Sandards ................................................................................................................. 108
Fig. 9-5: Layout of samples .................................................................................................................. 109
Fig. 9-6: Start Test ................................................................................................................................ 109
Fig. 9-7: Select the Test and Layout ...................................................................................................... 110
Fig. 9-8: Choose NO. Sample IDs .......................................................................................................... 110
Fig. 9-9: Test Results RLU...................................................................................................................... 111
Fig. 9-10: Concentration of Samples....................................................................................................... 112
Fig. 9-11: Graphic of a standard curve ................................................................................................... 112
Fig. 9-12: Save measured test................................................................................................................. 112
Fig. 9-13: Open Saved Plates .................................................................................................................. 113
Fig. 9-14: Printing Assay ......................................................................................................................... 113
Fig. 10-1: Report - Sample...................................................................................................................... 116
Fig. 10-2: Report – Matrix Quanitative Test 1/2 ....................................................................................... 117
Fig. 10-3: Report – Matrix Quanitative Test 2/2 ....................................................................................... 118
Fig. 10-4: Report – Table (example) ........................................................................................................ 119

AUTOBIO LABTEC INSTRUMENTS CO.,LTD
No.199 15th Ave, National Eco & Tech Zone, Zhengzhou, Henan, China 450016
Tel: [86]- 371-6798 5313 Fax: [86]-371-6798 5804

Operating Manual Control-And Evaluation Software For Autobio and

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Operating Manual

Autobio Labtec Instruments

© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft I

3 Main Screen ..................................................................................... 22

4 Defining Test- and Layout ................................................................ 26

5 Run a Test ........................................................................................ 56

6 Saved Plates and Samples ................................................................ 74

II AUTOsOFT © Autobio Labtec Instruments |2016 | DocVersion: 2.8

8 Measurements without evaluation ................................................. 101

9 Example of use ............................................................................... 105

10 Appendix ....................................................................................... 115

© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft III

Flexible and simple assay setup and operation

Replicate elimination, validation and quality control

© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft 1

Patient based data management

Printout and Export

2 AUTOsOFT © Autobio Labtec Instruments |2016 | DocVersion: 2.8

2.1 Installing AUTOsoft

2.1.1 System Requirements

2.1.2 Special requirements for Widows Vista (Windows7/8/10)

Disabling UAC under Windows Vista™

© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft 3

2.1.3 Running the Setup Program

4 AUTOsOFT © Autobio Labtec Instruments |2016 | DocVersion: 2.8

Adjustment of the USB to Serial Port driver

Fig. 2-1: Select USB Serial Port in the Device Manager

© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft 5

Fig. 2-2: Restore Default Settings for USB Serial Port

Fig. 2-3: Modify Advanced Settings for USB Serial Port

6 AUTOsOFT © Autobio Labtec Instruments |2016 | DocVersion: 2.8

Fig. 2-4: AUTOsoft desktop icon

2.4 Error logging

2.5 Initial setup of AUTOsoft

Fig. 2-5: License (example)

© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft 7

Instrument Type LUMO

Fig. 2-6: Login admin

Fig. 2-7: Change Password

8 AUTOsOFT © Autobio Labtec Instruments |2016 | DocVersion: 2.8

Fig. 2-8: Add New User

© Autobio Labtec Instruments |2016 | DocVersion: 2.8 AUTOsoft 9

Reset admin password to default if password is lost

2.6 Configuring Options

2.6.1 Data Export

10 AUTOsOFT © Autobio Labtec Instruments |2016 | DocVersion: 2.8

Fig. 2-9: Setup | Options | Data Export

2.6.2 Item Classification

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Fig. 2-10: Setup | Options | Item Classification

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Fig. 2-11: Setup | Options | Others

Show message after measurement is completed

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2.6.4 Sample Info

Fig. 2-12: Setup | Options | Sample Info

2.7 Configuring the Instrument

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Setup | Instrument dialog LUmo

Setup | Instrument dialog PHOmo

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Table 2-6: Setup Instrument Dialog

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