iSED® & iSED® ELITE Automated Erythrocyte Sedimentation

Rate Analyzer
Inter-sample Carryover Test Protocol

Scope
The purpose of this study is to demonstrate that the sequence of testing does not affect the
measured values on the iSED and iSED ELITE analyzers.

Sample Requirements
• Samples must be collected in EDTA anticoagulant 13 x 75 mm closed sample tube
(lavender tube) with at least 3.5 mL minimum sample volume.
• The samples must be non-hemolyzed and without presence of clots.
• The samples must be processed within four (4) hours of withdrawal.
• The study will be performed selecting samples with the following criteria:
• one (1) sample with result between 5 and 15 mm/hr. (low ESR result)
• one (1) sample with result between 55 and 65 mm/hr. (high ESR result)

Instruments and Materials

• Four (4) plain (no anticoagulant) sample collection tubes
• 1 mL standard transfer pipettes
• iSED or iSED ELITE analyzer
• Computer with Microsoft Excel®

Sample Selection
Process batches of twenty (20) random samples on the iSED until one sample from each of the
two (2) ranges defined in the “Sample Requirement” section is collected.
1. Press the “Add sample” icon on the instrument touch screen and wait for the instrument
mixing wheel to position for loading the sample.
2. Load a sample tube with the barcode oriented toward the right for sample ID recognition.

112-07-005 Rev 1 1
iSED Inter-sample Carryover Test
Protocol

Proprietary & Confidential - Page 1 of 4 - Uncontrolled if Printed

 3. Wait for the sample ID recognition and remove the fingers from the sample loading
aperture.
4. Wait for the instrument mixing wheel to position to the next available position.
5. Continue to load sample tubes into the analyzer following steps two (2) through four (4)
until all the open positions are filled.
6. Wait for the analyzer to complete processing the samples.
7. Remove the samples from the collection tray.
8. Analyze results ensuring that one sample from each of the two (2) ranges defined in the
“Sample Requirement” section is located. If necessary, repeat this process until all the
result ranges are collected.

Sample Preparation
1. Mix each selected sample by mild inversion for at least three (3) minutes.
2. Remove the stopper from two (2) plain sample collection tubes.
3. Using the transfer pipette transfer 1ml of the high ESR result sample to each empty tube
and replace the tube stopper.
4. Mark the empty tubes with the value a1 and a2.
5. Close the primary sample tube with high ESR result.
6. Discard the transfer pipette.
7. Remove the stopper from the other two (2) empty sample collection tubes.
8. Using the transfer pipette transfer 1ml of the low ESR result sample to each empty tube
and replace the tube stopper.
9. Mark the empty tubes with the value b1 and b2.
10. Replace the primary sample tube with low ESR result.
11. Discard the transfer pipette.

Processing Samples using iSED analyzer

1. Press the icon “load sample with manual ID” on the instrument touch screen and wait for
the instrument mixing wheel to position for loading the sample.
2. Enter the ID “a1” on the touch screen, press enter three (3) times and load the sample a1
on the mixing wheel.
3. Wait for the instrument mixing wheel to position to the next available position.
4. Press the icon “load sample with manual ID”
5. Enter the ID “a2” on the touch screen, press enter three (3) times and load the sample a2
on the mixing wheel.
6. Wait for the instrument mixing wheel to position to the next available position.
7. Press the icon “load sample with manual ID”
8. Enter the ID “b1” on the touch screen, press enter three (3) times and load the sample b1
on the mixing wheel.
9. Wait for the instrument mixing wheel to position to the next available position.
10. Press the icon “load sample with manual ID”
11. Enter the ID “b2” on the touch screen, press enter three (3) times and load the sample b2
on the mixing wheel.

112-07-005 Rev 1 2

iSED Inter-sample Carryover Test Protocol

Proprietary & Confidential - Page 2 of 4 - Uncontrolled if Printed
 12. Wait 10 minutes before proceeding to the next step.
13. Repeat this process from step one (1) to ten (10) until the desired number of replicates
have been performed.
14. Save all instrument printouts.

Data Analysis
1. Record the ESR results from the iSED analyzer on the Excel Sample Carryover worksheet
provided by ALCOR. To open the spreadsheet, click on the Excel object. The % carryover
will be automatically calculated.

2. To calculate the % carryover manually, use the following formula; where k is the carryover
result expressed in percentage.

3. Calculate the average carryover for all four measurements.

4. An average K values of less than 10 % is considered acceptable.

112-07-005 Rev 1 3

iSED Inter-sample Carryover Test Protocol

Proprietary & Confidential - Page 3 of 4 - Uncontrolled if Printed
112-07-005 (DOC-2824) Ver. 1

Approved By:
(CO-3153) iSED2.0 Performance study procedures and reports
Description

Release of relevant performance study procedures and reports prior to release of iSED2.0 to production. These are verification and validation documents for this project.

Justification

Required testing reports for Verification and Validation activity record.

Assigned To: Initiated By: Priority: Impact:

Joe Langella Joe Langella Medium Major

Version History:
Author Effective Date CO# Ver. Status

Joe Langella January 26, 2023 8:26 AM EST CO-3153 1 Published

Belinda Fralick December 1, 2022 2:03 PM EST CO-3284 0 Superseded

Proprietary
Proprietary&&Confidential
Confidential -- Page 4 of
Page 1 of 14 -- Uncontrolled
Uncontrolledif if Printed
Printed