Main modifications to Phoresis software

INFORMATION NOTE FOR USERS
MAIN MODIFICATIONS TO
PHORESIS SOFTWARE
Release 8.60
2 January 2013
PHORESIS RELEASE 8.60
SUMMARY
I. WHAT'S NEW ....................................................................................................................................................................... 5
A. SHARED VERSION FOR ALL SEBIA INSTRUMENTS ................................................................................................................................. 5
B. URINE TECHNIQUE ON CAPILLARYS 2 FLEX-PIERCING .................................................................................................................... 5
C. IMMUNOTYPING URINE TECHNIQUE ON CAPILLARYS 2 FLEX-PIERCING ...................................................................................... 5
II. IMPROVEMENTS .................................................................................................................................................................. 5
A. HBA1C TECHNIQUE (CAPILLARYS 2 FLEX-PIERCING) ..................................................................................................................... 5

1. Specific improvements to the calibration in the HbA1c technique ...................................................................................... 5
a) Ability to keep calibrations performed even if language is changed ....................................................................................................... 5
b) Calibration information (management of a single segment) ................................................................................................................... 6
c) Implementation of color codes on calibrations performed ..................................................................................................................... 6
d) Possible viewing of a calibrator profile .................................................................................................................................................... 7
e) Management of calibrator lot number and/or concentration changes ................................................................................................... 7
f) Messages appearing when analyzing a calibrator in release 8.60 ......................................................................................................... 11
g) Worklist: creation of a link between the calibration ID and the related calibration information table................................................ 13
h) Display of a message requesting to recalibrate the system when changing buffer lot number ............................................................ 14
i) Changing the limits of gross % A1c for the level 1 and level 2 calibrators .............................................................................................. 15
j) Modification of search parameters for A0 peak .................................................................................................................................... 15
2. Functional improvements specific to the HbA1c method .................................................................................................... 15
a) Warning in case of Hb A2 higher than 3%.............................................................................................................................................. 15
b) Levey-Jennings HbA1c: visualization of the values of graph points ........................................................................................................ 15
c) Simplification of entry of normal values ................................................................................................................................................ 17
d) Search by criteria: implementation of a function for profile search by “atypical samples” and “samples with increased HbA1c” ........ 18
e) Search by day with addition of two new columns: “atypical profiles” and “profiles with increased HbA1c value” .............................. 19
f) Non display of the HbA1c result (%, mmol/mol and eAG) in case of shoulder on the HbA1c peak with red warning triangle on the
profile ......................................................................................................................................................................................................... 20
g) Improvement of date management and of calculation of patient age in months for Hb and HbA1c techniques ................................. 21
h) CAPILLARYS HbA1c technique: Modification of minimum OD threshold for HbA1c controls ................................................................ 21
i) Modification of the percentage threshold of the “Hb F or variant” fraction beyond which no result is given...................................... 23
j) Securing of the HbA1c - Hb link............................................................................................................................................................... 23
k) No transmission of profiles with red warning to central informatic ...................................................................................................... 23
B. CAPILLARYS 2 ......................................................................................................................................................................... 23
C. CAPILLARYS 2 FLEX-PIERCING ................................................................................................................................................ 23
D. HEMOGLOBIN(E) TECHNIQUE (CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING, MINICAP, MINICAP FLEX-PIERCING).................. 24
1. Modification of zones titles and peaks identification (ID).................................................................................................. 24
2. Hb AFSC control ................................................................................................................................................................. 26
3. Deletion of the Hb AF control from the list of the controls ................................................................................................ 26
4. Variants library .................................................................................................................................................................. 27
5. Unmodifiable detection position of Hb A ........................................................................................................................... 29
6. Adjustment of the Hb A2 identification Template ............................................................................................................. 29
E. CORD BLOOD TECHNIQUE (ON CAPILLARYS 2 AND CAPILLARYS 2 FLEX-PIERCING) ......................................................................... 30
1. Modification of the zones titles and of the peaks identification (ID) ................................................................................. 30
2. Variants library .................................................................................................................................................................. 30
3. Unmodifiable detection position of Hb F ........................................................................................................................... 31
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4.Management of Flex and Non Flex modes......................................................................................................................... 31
F. SEVERAL OR ALL TECHNIQUES ........................................................................................................................................................ 31
1. Transfer of flags on mosaic screen .................................................................................................................................... 31
2. HbA1c controls level 1 and level 2 defined as QC, by default .............................................................................................. 31
3. QC: new orange flag, if value is outside of the targeted values entered .......................................................................... 32
4. QC analysis with yellow, purple or red flags and statistics ................................................................................................ 32
5. Results report ..................................................................................................................................................................... 32
6. Global redesign of the result table ..................................................................................................................................... 33
7. Levey-Jennings ................................................................................................................................................................... 33
8. Day’s worklist, worklist filterable by criteria, result table.................................................................................................. 34
9. Day’s worklist / worklist by criteria .................................................................................................................................... 35
10. Day’s worklist ..................................................................................................................................................................... 35
11. Option to include testing not yet performed ..................................................................................................................... 35
12. Search by criteria ............................................................................................................................................................... 36
13. Removal of the note “Pathological” .................................................................................................................................. 36
14. HOST .................................................................................................................................................................................. 36
15. Overlaying of the curves .................................................................................................................................................... 36
G. MINICAP IMMUNOTYPING .................................................................................................................................................... 36
H. CAPILLARYS IMMUNOTYPING ................................................................................................................................................ 38
I. MINICAP TRACEABILITY OF THE REAGENTS ..................................................................................................................................... 39
1. Configuration of reagent barcodes on MINICAP and CAPILLARYS ..................................................................................... 39
2. Window of technique change ............................................................................................................................................ 40
a) Case of a 12-character reagent ID ......................................................................................................................................................... 40
b) Case of a 14-character reagent ID: ........................................................................................................................................................ 41
3.Window of container change ............................................................................................................................................. 43
J. MINICAP IMMUNOTYPING AND IMMUNOTYPING URINE ....................................................................................................... 43
K. CAPILLARYS PROTEIN(E) 5 ...................................................................................................................................................... 44
L. ANALYSIS COUNTERS ON CAPILLARYS AND MINICAP ..................................................................................................................... 44
View of the analysis counter window......................................................................................................................................... 45
M. POSITIVE IDENTIFICATION ASSIST/HYDRASYS 2/GELSCAN ........................................................................................................ 46
1. Positive identification is done using three independent steps ........................................................................................... 46
2. Selection window for the different steps to follow (step 1, step 2 and step 3) .................................................................. 47
3. Step 1/3 (ASSIST) ................................................................................................................................................................ 47
4. Step 2/3 (HYDRASYS 2)....................................................................................................................................................... 53
5. Step 3/3 (GELSCAN) ........................................................................................................................................................... 56
6. Displays .............................................................................................................................................................................. 59
a) Worklist.................................................................................................................................................................................................. 59
b) Recovery window and Results report .................................................................................................................................................... 59
N. GELSCAN / K20: CREATION OF A READING PROGRAM FOR K20 GELS ................................................................................................. 63
O. PHORESIS IMPROVEMENTS ......................................................................................................................................................... 64
1. Information in the recovery window indicating type of opening ....................................................................................... 64
2. Browsing by “Mosaic curve” .............................................................................................................................................. 65
3. Browsing by “Worklist” ...................................................................................................................................................... 66
4. Browsing by “Search by result” .......................................................................................................................................... 67
P. OTHER IMPORTANT INFORMATION ................................................................................................................................................. 67
III. IMPROVED FUNCTIONALITIES ............................................................................................................................................ 68
IV. QUALIFICATION/VALIDATION/VERIFICATION OF THIS NEW RELEASE OF PHORESIS ...................................................... 69
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RELEASE 8.60
I. What's new
A. Shared version for all SEBIA instruments

Shared version for all SEBIA instruments: CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING, MINICAP, MINICAP FLEX-
PIERCING, ASSIST and GELSCAN.
This version is not validated for CAPILLARYS NEONAT Hb on CAPILLARYS 2 or CAPILLARYS 2 NEONAT Fast.
B. Urine Technique on CAPILLARYS 2 FLEX-PIERCING 1

 Addition of test to menu.
 Same function as the Urine technique on CAPILLARYS 2.
 Sample probe lowered further into the sample tube in order to compensate for the difference in probe tip
between CAPILLARYS 2 and CAPILLARYS 2 FLEX-PIERCING (bevel tip).
 Normalization of profile display (like to CAPILLARYS 2 since version 6.50 and to MINICAP since version 7.42).
C. IMMUNOTYPING URINE Technique on CAPILLARYS 2 FLEX-PIERCING 2

 Addition of test to menu.
 Same as IMMUNOTYPING URINE technique on CAPILLARYS 2.
 Probe lowered further into the sample tube in order to compensate for the difference in probe tip between
CAPILLARYS 2 and CAPILLARYS 2 FLEX-PIERCING (bevel tip).
II. Improvements
A. HbA1c technique (CAPILLARYS 2 FLEX-PIERCING)
All the CAPILLARYS 2 FLEX‐PIERCING doing HbA1c must be updated to version 8.60, it is now possible
to update from version 8.50.
1. Specific improvements to the calibration in the HbA1c technique
a) Ability to keep calibrations performed even if language is changed
Calibrations are stored in the Daily file with the possibility to recover them in the new Daily file when the
language is changed (configuration by default).
A non-persistent option and by default not activated and is accessible from the language selection
display in the program configuration window; to let the user choose whether to recover or not the data.
1
As part of the accreditation (ISO 15189), if the laboratory wants to use this technique on this instrument, it must verify / validate this technique.
2
As part of the accreditation (ISO 15189), if the laboratory wants to use this technique on this instrument, it must verify / validate this technique.
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b) Calibration information (management of a single segment)
Addition in the HbA1c calibration visualization window, of the calibrator segments, even if this segment
has not been used for calibration since it is unmatched. The calibrator analysis appear in white, without
the colour code reserved for calibrations:
(a) all the calibrator segments analyzed are listed, even the unmatched ones,
(b) possible visualization of a calibrator profile,
(c) creation of color codes in the list of calibrations, indicating their level of conformity (cf. next section
c)).
c) Implementation of color codes on calibrations performed
The color code applies to all calibrations in the list with two calibrators:
 green color: the calibration is in conformity for the two calibration levels on each capillary;
 orange color: calibration problem on at least one capillary for at least one calibration level
(whatever the alert: yellow, purple,red or exclamation point);
 red color: no capillary could be calibrated, problem for one or both calibration levels
(whatever the alert: yellow, purple, red or exclamation point);
 no color for the unmatched calibrator analysis;
 a black triangle refers to the calibration being displayed.
This color coding is retroactive on calibrations made with releases earlier than release 8.60.
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d) Possible viewing of a calibrator profile
The user can click on the alert symbol shown in the table: each click on a symbol allows to view a profile.
The profile appears in the recovery window: one profile is displayed at a time.
e) Management of calibrator lot number and/or concentration changes
The target value entered is discriminant and is taken into account to see whether a calibration can be
added to the preceding ones or counted as a new calibration not to be averaged with the others.
Example: 2 calibrators of level 1 & 2, target values 30 and 90 mmol/mol, lot numbers 11111/01 and
22222/01.
During use, if the target value of level 1 is entered as 10 mmol/mol rather than 30 mmol/mol (with the
correct lot number), the calibration involving the analysis of this mistaken level 1 shall be treated as a
new calibration* requiring the user to redo his three calibrations. Calibrations will not be mixed between
those at 10 and 30 mmol/mol.
* Column ID in 'Calibration Information Data': counter reset at 0.
Reminder: a correct calibration is a calibration with which results can be rendered on at least one
capillary.
When a calibrator (level 1 and 2) is analyzed, in the event of a difference concerning the lot number
and/or the target concentration value, entered by the user, one of the 3 following messages will appear
for confirmation:
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 “Concentration and lot number are different from those currently used by PHORESIS. Do
you confirm your entry?”
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 “Concentration is different from that currently used by PHORESIS. Do you confirm your
entry?”
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 “Lot number is different from that currently used by PHORESIS. Do you confirm your entry?”
If the user validates his choice, he will then have to redo the three calibrations expected.
Note: if the operator confirms this change, only the calibrations undertaken after this validation will be
used. Otherwise, he will be able to operate a manual correction of the value entered for the next
calibration.
Attention, a calibration cannot be deleted a posteriori: this means that the user must redo, 3 correct
calibrations (with the right values and/or the correct lot number) if an error has still occurred upon
entry.
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f) Messages appearing when analyzing a calibrator in release 8.60
(1)In case of the passage of a calibrator does not allow a full calibration with another calibrator, one of the
two following messages will be automatically and systematically displayed by PHORESIS:
o Either: “Calibrator 'calibrator name' is in conformity for all capillaries.”
o Either: “Calibrator 'calibrator name' is NOT in conformity at least on one of the capillaries.”
(2) In the case of the passage of a calibrator allowing a full calibration with another calibrator, a message in
three parts will be automatically and systematically displayed by PHORESIS.
(a) The first part of the message shall consist of one of the two following messages:
 Either: “Calibrator 'calibrator name' is in conformity for all capillaries.”
 Either: “Calibrator 'calibrator name' is NOT in conformity at least on one of the capillaries.”
(b) The second part of the message shall consist of one of the two following messages:
 Either: “Calibration 'calibration ID' has been successful.”
 Either : “Calibration 'calibration ID' has not been successful.”
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(c) The third part of the message shall consist of one of the two following messages:
 Either: “There are calibrations in conformity for all capillaries, HbA1c results will be
computed for all capillaries.”
 Either: “Some capillaries are disabled.” “Repeat analysis of the calibrators or check wrong
capillaries by analyzing controls.”
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g) Worklist: creation of a link between the calibration ID and the related calibration information table
In worklist, click on the ID calibration brings up the window “calibration information”.
This window opens on the calibration corresponding to the ID which is visible in worklist but only on the
workstation on which the analysis was performed. Otherwise a message informed the user that the
calibrations used to treat the current sample are not viewable.
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h) Display of a message requesting to recalibrate the system when changing buffer lot number
When changing buffer lot number in technique HbA1c, a message appears asking the user to make a
calibration and stating that all samples will be discarded until the new calibration will not be made.
Any further analysis of samples or controls any rejected if the new calibration has not been performed, a
message informs the user: “Buffer lot has changed: a new calibration is required”.
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i) Changing the limits of gross % A1c for the level 1 and level 2 calibrators
The limits to the gross percentage of HbA1c for calibrator level 1 are now set at 4.6 and 5.7%, and 10.5
and 12.8% for calibrator level 2.
j) Modification of search parameters for A0 peak
The search windows have been refined:

HbA0 peak search position:
 145 +/- 35 for calibrators and controls,
 145 +/- 30 for any sample.
2. Functional improvements specific to the HbA1c method
a) Warning in case of Hb A2 higher than 3%
Addition of the “(!)” symbol to the name of the HbA2 fraction if the percentage of A2 is higher than 3%.
This alerts to the risk of beta-thalassemia, which may cause physiopathological interference on the value
of HbA1c and is explained in the instruction sheet. No explanation or meaning of this symbol in the
software, unlike the (*) of atypical profiles.
b) Levey-Jennings HbA1c: visualization of the values of graph points
Visualization in a tooltip of the HbA1c values for the points constituting the Levey-Jennings charts when
passing over it with the cursor: they are expressed in mmol/mol without decimal or in % with one
decimal.
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c) Simplification of entry of normal values
The normal values used for normal profiles are those of the row 4 fractions. If the normal value is
changed, the user can modify the values of the row 4 fractions, without having to modify the others.
Note: the other rows can be used to enter other normal values for atypical profiles.
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d) Search by criteria: implementation of a function for profile search by “atypical samples” and “samples with
increased HbA1c”
Search enabled by “atypical samples” and “with increased HbA1c value”.

Note: during a search by criteria, HbA1c calibrators are never visible in the list of search results unless the
search focuses specifically on HbA1c calibrators (by checking the field “Controls” of the section “patient
data” and selecting one of the calibrators).
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e) Search by day with addition of two new columns: “atypical profiles” and “profiles with increased HbA1c
value”
Addition of 2 tables: “atypical profiles” and “profiles with increased HbA1c” in the “database history”
window for HbA1c technique.
For the other techniques, these tables are not visible and buttons for displaying "atypical profiles" and
“profiles with increased HbA1c” are visible but greyed out.
Analyzes of calibrators are not taken into account.
The new selection tables only contain the samples analyzed from version 8.60. Those acquired with
previous versions of PHORESIS will not be visible.
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f) Non display of the HbA1c result (%, mmol/mol and eAG) in case of shoulder on the HbA1c peak with red
warning triangle on the profile
If a shoulder is detected on the HbA1c peak, no HbA1c result is computed in the worklist, the reminder
window or the Results report. A red warning triangle appears on the profile.
HbA1c peak still retains its name “HbA1c” what allows to distinguish this case from cases where the peak
HbA1c would not been detected.
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g) Improvement of date management and of calculation of patient age in months for Hb and HbA1c techniques
The age of the patient in months is calculated once the data is imported.
If the birth date is known then the patient's age in months is calculated from the birth date and the
sampling date if known, otherwise from the birth date and date of analysis. In the latter case, this age is
an approximation, but more accurate than using the date of the PC.
If the birth date is not known then the age can be entered directly from the worklist (or received by the
HOST).
h) CAPILLARYS HbA1c technique: Modification of minimum OD threshold for HbA1c controls
By default, the OD threshold value is set at 0.09 instead of 0.10 for HbA1c controls (level 1 & 2).
Note: the OD threshold values for the calibrators and the atypical samples remain unchanged: 0.07 and
0.10 respectively.
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i) Modification of the percentage threshold of the “Hb F or variant” fraction beyond which no result is given
The limit acceptable percentage of the "Hb F or variant" peak is now 16%. Beyond this (value strictly
higher than 16%), no result is rendered with red warning on the profile. The results will not appear either
in the recovery window, or in the worklist, or in the printout.
j) Securing of the HbA1c - Hb link

The HbA1c - Hb link is secure when attempting to change the sequence number of the side of Hb.
k) No transmission of profiles with red warning to central informatic

Profiles with red warning where no result is given by PHORESIS (case with Hb F too high, shoulder on
HbA1c and / or HbA0 peaks ...) are not transmitted to the central IT.
B. CAPILLARYS 2
 Technique change enabled at startup.

 PROTEIN(E) 6 technique: case of the option for additional decontamination between 2 sample tubes: rinsing by
buffer solution instead of demineralised water. Modification of the option text indicating the over-consumption
of buffer solution.
 Greying out of access to vial change once extinction is complete.
C. CAPILLARYS 2 FLEX-PIERCING
 Technique change enabled at startup (same as 8.51).

 Priming of the hemolysing solution channel on launch in Hb and HbA1c techniques: the objective is to reduce the
dilution problems sometimes encountered on the 1st segment after startup on certain devices (some incorrectly
diluted wells with too little hemolysing solution). 5 primings by syringe are now carried out upon every startup in
Hb and HbA1c techniques, with no impact on the maximum number of tests that can be carried out per kit.
 Greying out of access to container change once extinction is complete.
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D. HEMOGLOBIN(E) technique (CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING, MINICAP,
MINICAP FLEX-PIERCING)
1. Modification of zones titles and peaks identification (ID)
 Zones titles:
o In the zones titles above the profile, replacement of «Z2», «Z3»,» Z4», «Z5», «Z6», «Z7» and «Z9» by
«Z(C)», «Z(A2)», «Z(E)», «Z(S)», «Z(D)», «Z(F)» and «Z(A)».
o The default underlining of the zones titles has been removed for improved readability but the framing
of the zones title, in case of automatic detection or manual quantification of a peak in this zone, has
been maintained.
 The automatic numbering 1, 2, 3... of the unidentified peaks is removed when zones are displayed.
 Operation on unzoned profile remains the same (automatic numbering 1, 2, 3… in the absence of identified Hb A
but with recentering profile by default ie curve with yellow warning triangle; presence of only “?” in case of
recentering problem, ie curve with red warning triangle).
 Residual automatic numbering 1, 2, 3… is evolutive according to the manual removal of peak. For example, on a
profile with peaks “1”, “2”, “3”, if the peak “2” is removed by the user then the peak “3” will be automatically
renamed “2”. The incremental sequence is then respected. No change, however, when a peak is added manually.
 This modification of the zones title and peaks identification allows the user to easily link zones and peaks.
Modifications are captured in the recovery window and in the Results report.
 Identification of peaks in the presence of zones:
o Peaks identification is unchanged for peak currently identified by the templates: “Hb A”, “Hb F or Hb
variant” (or “Hb F” according to the age of the patient), “Hb A2”, “Abnormal Hb + Hb A2” or “Hb C or
Hb variant” (or “Hb C” for AFSC control);
o “Hb A zone”, “Hb F zone”, “Hb A2 zone” or “Hb C zone”, for a peak detected in zone “Z(A)”, “Z(F)”,
“Z(A2)” or “Z(C)” respectively, and would not have been identified “Hb A”, “Hb F or Hb variant”, “Hb F”,
“Hb A2”, “Abnormal Hb + Hb A2”, “Hb C or Hb variant” or “Hb C”;
o “Hb E zone”, “Hb S zone”, “Hb D zone” for a peak detected in zones Z(E), Z(S) or Z(D) respectively;
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o “Z1 zone”, “Z8 zone”, “Z10 zone”, “Z11 zone”, “Z12 zone” to “Z15 zone” for the peaks detected in the
other zones;
o in the event that 2 or more peaks are detected in the same zone, a suffix "-1", "-2", etc…. is added to
the title. The manual withdrawal of a peak does not change the suffix. For example, withdrawing the
peak “Z11 zone-1” will not change “Z11 zone-2” to “Z11 zone-1” to maintain traceability.
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 Recall of a curve:
o in release 8.60, recall of a curve obtained in an earlier release:
 peaks identification remains unchanged (identification of the earlier release is saved),
 zones identification is updated according to the release 8.60 ["Z(C)",…] ;
o in an earlier release, recall of a curve obtained in release 8.60 :
 peaks identification of the release 8.60 remains unchanged;
 zones identification go back to those of the earlier release.
 Zones identification depends on the retrieval release, peaks identification depends on the acquisition
release.
2. Hb AFSC control
Hb C peak is identified “Hb C”, and not “Hb C or Hb variant”.
3. Deletion of the Hb AF control from the list of the controls

However, the old profiles of Hb AF control are still labeled and identified as control.
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4. Variants library
 Improvement of the display of variants within tooltips and the text is no longer cut: the variants can now be
displayed as a table within tooltips with several columns (at least 2). The empty space at the bottom of the list is
calibrated regardless of the number of lines in the tooltip, there is no longer the text clippings as seen for certain
languages, namely in Chinese, in the older releases.
 Improvement of the titles of variant description tooltips: each zone has a title, depending on the cases, in the '-
Zxx zone -' or '- Hb xx zone - ' format.
Note: in releases 6.50/8.51/7.48, only the zone tooltips with peak IDs had a title.
 Variants named in the title have been removed from the underlying list.
 Highlighting of peaks of variants hidden by the normal Hb A fraction and of peaks of variants of the alpha chain
hidden by the normal Hb A2 fraction. Notification is made using a star adjacent to the variant name and a
resumption of legend in English (“hidden peak”) and in French (“pic non visible” rather than “pic masqué” in order
to avoid the accent bug) at the bottom of the tooltip. This only concerns zones Z(A) and Z(A2).
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 Update of the list of variants: the variants have been updated (190 major variants in total) and rescheduled
[same order that earlier releases (migration order of the capillary technic) BUT in release 8.60 the minor peaks
are put at the end of the list, to simplify the reading].
Zone No List of variants

Hb Santa Ana free alpha chain, Hb Mizuho (minor peak), Hb delta A'2, Hb alpha A2, Hb T-Cambodia, «Savaria» Hb A2
variant, «Chad» Hb A2 variant, «Arya» Hb A2 variant, «Hasharon» Hb A2 variant, «Fort de France» Hb A2 variant,
«Ottawa» Hb A2 variant, «Shimonoseki» Hb A2 variant, «Stanleyville II» Hb A2 variant, «O-Indonesia» Hb A2 variant,
«G-Norfolk» Hb A2 variant, «San Antonio» Hb A2 variant, «Handsworth» Hb A2 variant, «Matsue-Oki» Hb A2 variant,
1
«Memphis» Hb A2 variant, «Q-Iran» Hb A2 variant, «G-Waimanalo» Hb A2 variant, «Russ» Hb A2 variant, «Q-India» Hb
A2 variant, «Montgomery» Hb A2 variant, «Watts» Hb A2 variant, «G-Pest» Hb A2 variant, «Winnipeg» Hb A2 variant,
«Queens» Hb A2 variant, «Inkster» Hb A2 variant, «Chapel Hill» Hb A2 variant, «Q-Thailand» Hb A2 variant, «Park
Ridge» Hb A2 variant
Hb F-Hull, Hb F-Texas-I, Hb Constant Spring, Hb C-Harlem (C-Georgetown), «Boumerdes» Hb A2 variant, «Bassett» Hb
A2 variant, «Tarrant» Hb A2 variant, «Manitoba I» Hb A2 variant, «St. Luke's» Hb A2 variant, «Setif» Hb A2 variant,
Z(C)
«Sunshine Seth» Hb A2 variant, «Titusville» Hb A2 variant, «Swan River» Hb A2 variant, «Manitoba II» Hb A2 variant,
«Val de Marne» Hb A2 variant
Hb Chad (E-Keelung), Hb O-Arab, Hb E-Saskatoon, «Dallas» Hb A2 variant*, «Toulon» Hb A2 variant*, «Bonn» Hb A2
variant*, «Chicago» Hb A2 variant*, «Fontainebleau» Hb A2 variant*, «Hekinan» Hb A2 variant*, «Mosella» Hb A2
Z(A2) variant*, «Aztec» Hb A2 variant*, «Frankfurt» Hb A2 variant*, «M-Boston» Hb A2 variant*, «Owari» Hb A2 variant*,
«Twin Peaks» Hb A2 variant*, «Conakry» Hb A2 variant*, «Gouda» Hb A2 variant*, «Jura» Hb A2 variant,
«Nouakchott» Hb A2 variant
Hb Seal Rock, Hb Köln (Ube-1), Hb Buenos Aires (minor peak), Hb M-Saskatoon (minor peak), Hb A2-Babinga, Hb G-
Z(E) Siriraj, Hb Agenogi, Hb Sabine, Hb Santa Ana, Hb Savaria, «M-Iwate» Hb A2 variant, «Wayne» Hb A2 variant (peak 1),
Denatured Hb C
Hb Arya, Hb Hasharon (Sinai), Hb Dhofar (Yukuhashi), Hb Shimonoseki (Hikoshima), Hb O-Indonesia (Buginese-X), Hb
Ottawa (Siam), Hb Fort de France, Hb Montgomery, Hb G-Copenhagen, Hb S-Antilles, Hb Handsworth, Hb S-Oman
Z(S) (peak 2), Hb Hamadan, Hb Russ, Hb Stanleyville II, «Lombard» Hb A2 variant, «Tatras» Hb A2 variant, «Cemenelum»
Hb A2 variant, «Jackson» Hb A2 variant, «Hopkins-II» Hb A2 variant, «J-Broussais» Hb A2 variant (alpha 2), Denatured
Hb O-Arab
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Hb Memphis, Hb Leiden, Hb Muravera, Hb D-Bushman, Hb G-Norfolk, Hb S-Oman (peak 1), Hb Matsue-Oki, Hb Osu
Christiansborg, Hb D-Punjab (D-Los Angeles), Hb G-Waimanalo (Aida), Hb Muskegon, Hb D-Ibadan, Hb Buenos Aires
(minor peak), Hb Q-India, Hb Lepore (Lepore-BW), Hb Q-Iran, Hb Summer Hill, Hb G-Philadelphia, Hb D-Ouled Rabah,
Hb Yaizu, Hb San Antonio, Hb Watts, Hb Ferrara, Hb Köln (Ube-1), Hb Fort Worth, Hb Korle-Bu (G-Accra), Hb G-Taipei,
Hb D-Iran, Hb St. Luke's, Hb G-Coushatta (G-Saskatoon), Hb Inkster, Hb Winnipeg, Hb Zürich, Hb G-Pest, Hb Queens
Z(D)
(Ogi), Hb Setif, Hb P-Nilotic, Hb Sunshine Seth, Hb Titusville, «Le Lamentin» Hb A2 variant, «J-Meerut» Hb A2 variant,
«J-Rajappen» Hb A2 variant, «J-Anatolia» Hb A2 variant, «J-Oxford» Hb A2 variant, «Ube 2» Hb A2 variant, «J-
Broussais» Hb A2 variant (alpha 1), «J-Toronto» Hb A2 variant, «Mexico» Hb A2 variant, «J-Tongariki» Hb A2 variant,
«Neuilly-sur-Marne» Hb A2 variant, «J-Paris-I» Hb A2 variant (alpha 2), «J-Habana» Hb A2 variant, «J-Paris-I» Hb A2
variant (alpha 1), «Wayne» Hb A2 variant (peak 2), Denatured Hb E
Hb Willamette, Hb Alabama, Hb Chapel Hill, Hb Park Ridge, Hb Porto Alegre, Hb Q-Thailand (G-Taichung), Hb Sabine,
Hb Bassett, Hb Rampa, Hb G-San José, Hb Barcelona, Hb Geldrop Santa Anna, Hb Richmond, Hb Boumerdes, Hb Swan
Z(F)
River, Hb Burke, Hb Tarrant, Hb Presbyterian, Hb Manitoba II, Hb Manitoba I, Hb Port Phillip, «J-Rovigo» Hb A2 variant,
Denatured Hb S, Denatured Hb D-Punjab
Hb Lansing, Hb Hinsdale, Hb Ypsilanti (Ypsi - peak 1), Hb Alberta, Hb Val de Marne (Footscray), Hb Kempsey, Hb Shelby
8
(Hb Leslie), Hb Atlanta, Hb Ypsilanti (Ypsi - peak 2), Hb Rainier, Hb Athens-GA (Waco), Hb Debrousse
Hb Olympia, Hb Gorwihl (Hinchingbrooke), Hb Phnom Penh*, Hb Silver Springs*, Hb La Coruna*, Hb Bougardirey-
Mali*, Hb Dallas*, Hb Toulon*, Hb Austin*, Hb Bonn*, Hb Buenos Aires (Bryn Mawr, major peak)*, Hb Chicago*, Hb
Okayama*, Hb Fontainebleau*, Hb Raleigh*, Hb Hekinan*, Hb Mosella*, Hb Aztec*, Hb Little Rock*, Hb Frankfurt*, Hb
Z(A) Bethesda*, Hb M-Boston (M-Osaka)*, Hb Brisbane (Great Lakes)*, Hb Mizuho*, Hb Grange Blanche*, Hb San Diego*,
Hb M-Saskatoon (main peak)*, Hb Malmö*, Hb Minneapolis Laos*, Hb Owari*, Hb Rhode Island (Southwark)*, Hb Twin
Peaks*, Hb Wood*, Hb Conakry*, Hb Coimbra (Ingelheim)*, Hb Linköping (Meilahti)*, Hb Templeuve*, Hb Alzette*, Hb
Ty Gard*, Hb Gouda*, Hb Syracuse*, Hb Fort Dodge, Hb Camperdown, Hb Jura
10 Hb Nouakchott, Hb Wayne (peak 1), Hb M-Iwate (M-Kankakee), Hb Camden (Tokuchi), Hb Hope
Hb Vaasa, Hb Providence (X-Asn peak), Hb Tacoma, Hb Corsica, Hb K-Woolwich, Hb Lombard, Hb Andrew Minneapolis,
11 Hb Fannin Lubbock, Hb Kaohsiung (New York), Hb Osler (Fort Gordon), Hb Himeji, Hb Jackson, Hb Tatras, «I (I-Texas)»
Hb A2 variant
Hb Bart's, Hb Cemenelum, Hb Wayne (peak 2), Hb Hopkins-II, Hb J-Calabria (J-Bari), Hb J-Tongariki, Hb Providence (X-
Asp peak), Hb J-Meerut (J-Birmingham), Hb J-Broussais (Tagawa-I - alpha 2), Hb J-Rajappen, Hb Grady (Dakar), Hb Le
12 Lamentin, Hb J-Anatolia, Hb Hikari, Hb J-Broussais (Tagawa-I - alpha 1), Hb J-Chicago, Hb J-Toronto, Hb J-Oxford (I-
Interlaken), Hb Ube-2, Hb J-Meinung (J-Bangkok), Hb Neuilly-sur-Marne, Hb Mexico (J-Paris-II), Hb J-Paris-I (J-Aljezur -
alpha 1), Hb J-Habana, Hb J-Baltimore (N-New Haven), Hb J-Paris-I (J-Aljezur - alpha 2), Hb K-Ibadan
13 Hb N-Baltimore (Hopkins-I), Hb J-Rovigo, Hb J-Norfolk (Kagoshima), Hb J-Kaohsiung (J-Honolulu)
14 Hb N-Seattle
15 Hb I (I-Texas)
5. Unmodifiable detection position of Hb A

In the Hb A detection table, the detection position of Hb A can not be modified by the user.
6. Adjustment of the Hb A2 identification Template

To recover the rapid recentering of profiles with Hb A2 (on CAPILLARYS 2 only).
Page 29/70
E. Cord Blood technique (on CAPILLARYS 2 and CAPILLARYS 2 FLEX-PIERCING)
1. Modification of the zones titles and of the peaks identification (ID)
 Zones titles: in the zones titles above the profile, replacement of “C1”, “C3”, “C4”, “C5”, “C7”, “C10” and “C12” by
“C(C)”, “C(E)”, “C(S)”, “C(D/G/K)”, “C(F)”, “C(A)” and “C(Bart)”. The underlining by default of the zones titles has
been removed for improved readability but the framing of the zones title, in case of automatic detection or
manual quantification of a peak in this zone, has been maintained;
 The automatic numbering 1, 2, 3 … of the unidentified peaks does not exist in case of zone display. The function
for an unzoned profile remains identical (automatic numbering 1, 2, 3 ... in case of absence of Hb F but with a
default recentering of the profile, i.e. curve with yellow panel; presence of “?” only in case of recentering problem
i.e. curve with red panel);
 Residual automatic numbering 1, 2, 3 ... changes in case of manual withdrawal of a peak. For example, in a profile
with peaks “1”, “2”, “3”, if peak “2” is withdrawn by the user, then peak “3” will automatically be renumbered
“2”.The incremental order is then respected. No change, however, when a peak is added manually.
 This functional modification allows the user to easily make the connection between the zones and peaks. The
modification is shown both in the retrieval window and in the Results report.
 Peaks identification:
o The peaks identification remains unchanged for peaks currently identified by the templates: “Hb F”,
“Hb A”, “Hb A2” and “Abnormal Hb + Hb A2”;
o “Hb F zone”, “Hb A zone” or “C2 zone”, for a peak detected in zone “C(F)”, “C(A)”, “C2” or “C(Bart)”
respectively, and which has not been identified as “Hb F”, “Hb A”, “Hb A2” or “Abnormal Hb + Hb”;
o “Hb C zone”, “Hb E zone”, “Hb S zone”, “Hb D/G/K zone” or “Hb Bart zone” for a peak detected in
zones “C(C)”, “C(E)”, “C(S)”, “C(D/G/K)” or “C(Bart)” respectively;
o “C6 zone”, “C8 zone”, “C9 zone” or “C11 zone” for the peaks detected in the other zones;
o In the event that 2 or more peaks are detected in the same zone, addition of a “-1”, “-2” etc…. index to
this name. The manual withdrawal of a peak does not change the index. For example, withdrawing the
peak “C11 zone-1” will not change “C11 zone-2” to “C11 zone-1” to maintain traceability.
 Recall of a curve:
o in release 8.60, recall of a curve obtained in an earlier release:
 peaks identification remains unchanged (identification of the earlier release is conserved),
 zones identification is updated according to the release 8.60 ["C(E)",…] ;
o in an earlier release, recall of a curve obtained in release 8.60 :
 peaks identification of the release 8.60 remains unchanged;
 zones identification goes back to those of the earlier release.
 Zones identification depends on the retrieval release, peaks identification depends on the acquisition
release.
2. Variants library
 Improvement of the display of variants within tooltips and the text is no longer cut: the variants can now be
displayed as a table within tooltips with several columns (at least 2). The empty space at the bottom of the list is
calibrated regardless of the number of lines in the tooltip, there is no longer the text clippings as seen for certain
languages, namely in Chinese, in the older releases.
 Improvement of the titles of variant description tooltips: each zone has a title, depending on the cases, in the '-
Cxx zone -' or '- Hb xx zone - ' format.
Note: in releases 6.50/8.51/7.48, only the zone tooltips with peak IDs had a title.
 Variants named in the title have been removed from the underlying list.
Page 30/70
3. Unmodifiable detection position of Hb F
In the Hb F detection table, the detection position of Hb F can not be modified by the user.
4. Management of Flex and Non Flex modes

Flex and Non Flex modes are managed.
F. Several or all techniques
1. Transfer of flags on mosaic screen
The flags (yellow, orange, red and purple triangles) are displayed in the mosaic screen, by default.
Applies to all techniques according to the existing alerts.
2. HbA1c controls level 1 and level 2 defined as QC, by default

The results of these controls are automatically compared with target custom values entered (by the
operator).
Page 31/70
3. QC: new orange flag, if value is outside of the targeted values entered
A flag (orange triangle) is added for QC when its values are outside the target values entered by the user.
The message “non-compliant analysis of control” for QC analysis with orange flag, is also displayed. This
alert is visible on mosaic window and recovery window.
It applies to all techniques.
4. QC analysis with yellow, purple or red flags and statistics
A QC analysis with a yellow, purple or red flag is not taken into account* for the statistics or the Levey-
Jennings (does not concern QC analysis with orange flag).
This analysis can be forced in the statistics and the Levey-Jennings if the user re-marks it as QC.
* Controls are not automatically associated by PHORESIS with a QC at the end of the migration if they
have an alarm. As with earlier releases, the user can manually associate a control (or any sample) to a
QC.
5. Results report
To all techniques, the Results report is the Results report of the current technique.
Page 32/70
6. Global redesign of the result table
Result table is accessible from the 'Curve modif./Fraction result table' menu.
Columns by default: see screenshot below. Can be customized via the framed buttons.
7. Levey-Jennings
Change from 200 to 500 points.
Page 33/70
8. Day’s worklist, worklist filterable by criteria, result table
 The columns on the left side can be fixed by the user, in order to improve the use and visualization of lists with
many columns. Fixed columns cannot be moved but can be resized, and always remain visible. Unfixed columns
can be expanded, resized and moved:
 Implementation of a configurable printing (multiple printing):

o printing of all samples with a simple “*”;
o printing by blocks (multiple printing) instead of printing by sequential numbers. The numbers are those
of the lines and not the numbers of the analysis. This optimizes the use of the sorting;
o printing the number of samples selected for the printout, option not enabled by default;
o memorization of last print mode set by the user in order not to have to repeat the setting for each print
session (for day's worklist and worklist in search by criteria).
Page 34/70
9. Day’s worklist / worklist by criteria
 Improved printout readability: creation of vertical separating lines and alternation of grey and white colour to
separate the rows; securing of printout at the paper border.
 Implementation of an option, not enabled by default, to print the number of selected samples for the printout.
10. Day’s worklist

 Resolution of the problem of loosing the worklist configuration (order and sizes of the columns).
 Improvement of the editing usability of certain cells, namely dates. In earlier releases, it was not possible to edit
the dates by moving from cell to cell in the same column.
 Possibility to edit the first line after the opening of the day's worklist.
 Securing of date editing. The chronological order is now respected. For example, it is not possible to edit a date of
birth after the date of analysis as it was the case in the earlier releases.
 Securing of date editing in short format mode. This securing applies regardless of the permitted date format,
which was not the case in the earlier releases.
 Day’s worklist stays open after closing the options window: in earlier releases, the day’s worklist was closed
when closing the options window.
 Possibility of managing the column “Reading Date” for display or printing. The same function was already present
in the worklist of search by criteria.
11. Option to include testing not yet performed

Implementation of an option to include analysis not yet done so that they are visible in the day’s worklist or in the
worklist after a search by criteria regardless of the serial number of the instrument. In earlier releases, these
samples were not visible when an instrument filter was applied.
Page 35/70
12. Search by criteria

Deactivation of unnecessary fields for the technique and management of criteria for multi-technique searches.
For multi-technique searches, only the criteria of the techniques for which analysis have been detected will be
visible in the worklist resulting from the search and in the Results report.
13. Removal of the note “Pathological”

The note “Pathological” appearing in the retrieval window for profiles without curves, is removed.
14. HOST
Release of the Host = 5.64
15. Overlaying of the curves

The possibility to overlay curves in search by criteria mode is implemented.
G. MINICAP IMMUNOTYPING
Creation of an automatic program on MINICAP: “optimized dilution”, which is recommended in the case of multiple
and simultaneous reactions with A/M or G/M, or G/A antisera.
This dilution allows adjusting the ratio between antiserum and sample.
Note: the MINICAP IMMUNOTYPING instruction sheet will be modified for the next instructions DVD (end 2012).
Page 36/70
Page 37/70
H. CAPILLARYS IMMUNOTYPING
Creation of an automatic program on CAPILLARYS: “optimized dilution”, which is recommended in the case of multiple
and simultaneous reactions with A/M or G/M, or G/A IgG, IgA and/or IgM antisera.
This dilution had to be performed manually on CAPILLARYS in earlier versions; now it is automatically performed when
using “optimized dilution” program.
This dilution allows adjusting the ratio between antiserum and sample.
Note: the CAPILLARYS IMMUNOTYPING kit manual will be modified for the next DVD Notices (end 2012)
Page 38/70
I. MINICAP traceability of the reagents
For entering barcodes, a barcode reader can be used like CAPILLARYS (see note release 8.51). The choice of manual
entry or with a barcode reader is done in windows of vial change and of technical change. The user can switch at any
time of an input mode to another without losing information.
Barcode reader: USB scanner for standard 1D barcodes.
1. Configuration of reagent barcodes on MINICAP and CAPILLARYS
Two types of reagent barcodes can be configured:

o the first containing only the lot number and the expiry date (12 characters),
o the second containing the lot number, expiry date and technique ID (14 characters).
In version 8.60, the MINICAP and CAPILLARYS configuration is, by default, the first option, i.e. with no
technique ID (12 characters). This configuration therefore allows the 14-character barcode to be read
without exploiting the information concerning the technique ID.
Page 39/70
2. Window of technique change
a) Case of a 12-character reagent ID
View of the window of technique change with data input options of the reagents:
View of the technique change window after scanning the information written on container 1, 12-character ID.
After the reagent data input, the barcode label shown in this window will change from green color to white.
For the identifier with 12 characters, a warning will confirm that the buffer in which the information was
recorded corresponds to the selected method.
Page 40/70
b) Case of a 14-character reagent ID:
View of the window of technique change with data input options of the reagents:
View of the technique change window after scanning the information of container 1, 14-character ID.
After the reagent data input, the barcode label shown in this window of technique change, the colour
switches from green to white.
Page 41/70
Note: the additional characters allow checking that the type of buffer is compatible with the selected
technique. In case of incoherence, a message informs the user and a new ID must be scanned.
For the identifier with 14 characters, a warning indicates any mismatch between the information stored for
the buffer and the selected method.
Page 42/70
3. Window of container change
View of the window of container change after data input of buffer 1 with the barcode reader.
The presence of these symbols indicates that the data for the corresponding reagents must be input with a
barcode reader.
This symbol indicates that the next data read with the barcode reader will be automatically assigned
to the reagent on which it is located.
This symbol indicates that the corresponding reagent for which the information must be entered
using the barcode reader but without indicating whether this information has already been scanned or not.
J. MINICAP IMMUNOTYPING and IMMUNOTYPING URINE
Only the IMMUNOTYPING technique with capped vials is visible in release 8.60.
Page 43/70
K. CAPILLARYS PROTEIN(E) 5
Removal of the PROTEIN(E) 5 technique in the list of techniques. The "PROTEIN 5" program remains available to allow
users to visualize past results.
L. Analysis counters on CAPILLARYS and MINICAP
(See After Sales Service for activation)
Thefollowing information is recorded:

 number of total analysis (theoretical number of analysis per rack),
 number of samples truly analyzed,
 number of analysis in 'reruns' (successive runs of the same sample),
 number of runs of controls for each type of control,
 number of aborted runs,
 number of maintenance cycles,
 number of technique changes,
 number of start-ups/shutdowns.
The number of analysis displayed is the maximum number of analysis from which the tubes without detection of liquid
are deducted when the capacitive detection is enabled and of which no barcode data has been input.
The number of analysis being rerun is the number of samples of which the barcode data has already been input in
PHORESIS within a given time frame. Indeed, the barcode of the analysis is searched within a certain number of days
prior to the date of acquisition. By default, the barcode is searched in the last 7 days.
All of these counters are saved by instrument number, by technique and by type of user. There are two types of users:
the “SAV” type, which is enabled when PHORESIS is opened with the “SAV” code, and the “CLIENT” type for all other
types of opening.
Page 44/70
View of the analysis counter window
Possibility of filtering by instrument, by analysis technique, by SAV or CLIENT mode.

Access via “Capillarys/analysis counters”
Note: the information contained in this window can be sent by e-mail.
Page 45/70
M. Positive identification ASSIST/HYDRASYS 2/GELSCAN
Creation of a positive identification system which assures patient traceability from the identification of the sample
tube on ASSIST until the final result obtained with GELSCAN.
The Results report shows the patient ID, the gel number and the position of the sample on the gel.
Barcode reade required: 2D Motorola DS4208 scanner (further referred to as HYDRAGEL barcode reader).
1. Positive identification is done using three independent steps
(1) Step 1/3 (ASSIST)

o Automated scanning of the barcodes on sample tubes, by the integrated ASSIST barcode reader.
o Simultaneous manual scanning of the applicator barcodes and their position in the wet chamber
with the HYDRAGEL barcode reader.
(2) Step 2/3 (HYDRASYS 2)

o Manual scanning of the gel barcode placed on the gel while on the plate of the HYDRASYS 2
migration module.
o Simultaneous manual scanning of the applicator barcodes and their position on the HYDRASYS 2
applicator carrier with the HYDRAGEL barcode reader.
(3) Step 3/3 (GELSCAN)

o Manual scanning of the gel barcode before scanning the gel with the GELSCAN.
Page 46/70
2. Selection window for the different steps to follow (step 1, step 2 and step 3)
3. Step 1/3 (ASSIST)
Use ASSIST wet chamber where the positions of applicators (numbered from 1 to 4) are identified with the
two-dimensional barcodes.
Stick the applicator barcodes (SEBIA, product number 9207) on the left side of applicators about 5 mm from
the edge:
Page 47/70
WARNING: The barcode label should not interfere with positioning of the applicator onto the HYDRASYS 2
applicator carrier
The barcodes on sample tubes are automatically scanned by the integrated barcode reader of ASSIST
instrument during the insertion of the sample racks into the instrument.
Remove the wet chamber from the ASSIST and position the applicators as shown below:
Position barcode reader on the wet chamber barcode and read: both barcodes (the applicator barcode and
the position barcode on the chamber) are scanned simultaneously.
Page 48/70
Aid for positioning of the light spot of the barcode reader for
simultaneous scanning the applicator barcode and the position
barecode of the wet chamber.
The green arrow indicates that the

rack can be inserted into the ASSIST A green arrow shows the
instrument. insertion field of applicator
barcodes.
Page 49/70
After scanning, the barcode numbers

appear in the corresponding fields.
Page 50/70
Sample barcodes are sent to the work

list: a message indicates the number
of samples with barcodes that have
been read.
Page 51/70
Barcodes are loaded in Modification of the first number of the

successive order into the worklist.
worklist.
Place the wet chamber and applicators into the ASSIST instrument and start the selected program.
Page 52/70
4. Step 2/3 (HYDRASYS 2)
Use an HYDRASYS 2 where the positions of applicators on the applicator carrier are identified with two-
dimensional barcodes.
On the plastic support of the gel (back side), stick one gel barcode (SEBIA, product number 9206) along the left
side of the gel about 10 mm from the upper edge. The barcode must be visible through the gel.
Place the gel on the plate of the migration module and scan the gel barcode.
Page 53/70
Place the applicators on the applicator carrier.
Place the light spot of the HYDRAGEL barcode reader on the applicator barcode and scan the applicator
barcode and the position barcode of the carrier (both barcodes are scanned at the same time).
The green arrow indicates the gel and

Guide for scanning simultaneously
applicator barcodes to scan.
applicator barcode and position barcode
on the applicator carrier.
Page 54/70
After scanning, the barcode

numbers appear in the
corresponding fields.
Page 55/70
5. Step 3/3 (GELSCAN)
Install the gel into the gel-holder, keep the small columns open and scan the barcode of the gel. Then close
the small columns of the the gel-holder.
Page 56/70
The green arrow indicates the insertion

code of the gel barcode (select the gel
type to scan).
Page 57/70
Read the gel with the GELSCAN according to the established procedure.
After having processed the 3 steps of the positive identification previously described, the traceability
information is displayed in the worklist, the recovery window and the Results report.
Page 58/70
6. Displays
a) Worklist
o number of the ASSIST sample rack,
o position of the tube on the ASSIST sample rack,
o position of the applicator in the ASSIST wet chamber,
o number of the sample applicator,
o position of the sample on the applicator,
o number of the HYDRAGEL gel,
o position of the sample applicator on the HYDRAGEL gel.
Example worklist and traceability:
b) Recovery window and Results report

o patient identification number and its position on the gel,
o - number of the gel.
Examples of recovery window and traceability:
Page 59/70
PROTEIN(E) technique:
Gel number + sample

position on the gel. Sample ID
Page 60/70
IF technique:
Sample ID
Gel number
Page 61/70
CSF ISOFOCUSING technique:
Sample ID
Gel number
CONCLUSION
The samples are linked to their electrophoretic pattern.
Note: Positive identification is applicable in release 8.60 for techniques: PROTEINS, IF, BENCE JONES, IF PENTA,
HR URINE, CSF and CSF ISOFOCUSING.
Page 62/70
N. GELSCAN / K20: creation of a reading program for K20 gels
Addition of the possibility to adjust the starting position of the reading and length of the profile.
A button named K20 enables or disables the K20 gel reading program.
Page 63/70
O. PHORESIS improvements
1. Information in the recovery window indicating type of opening
The order of curve consultation is different depending on the opening mode, the indication of the opening mode
allows to identify more easily the order of the curves.
Header bar displays information from where the result curve view originated.
Page 64/70
2. Browsing by “Mosaic curve”
Page 65/70
3. Browsing by “Worklist”
Page 66/70
4. Browsing by “Search by result”
P. Other important information
When updating from an earlier release to release 8.60, for the function of recentering in all Hb and HbA1c techniques,
the target of the detection position for HbA is LOST and returns to the default value.
Before update, note the table values for the detection of HbA (line "position detection"):
"CAPILLARYS/Settings/Device Configuration/Display Settings 2/2" and then manually change the values after
updating to avoid having to pass the 3 control segments.
Page 67/70
III. Improved functionalities
 Improved functionalities for sending data by e-mail with the option to delete the patient name, all these options
are configurable from the window of sending e-mail:
o Sending results by e-mail is a single button operation
o The data can be sent either in pdf format or as database backup..
o Whatever the transmission format selected, the options available are the same.
o A summary of the analysis contents transmitted is also sent via e-mail (see example where 2 HbA1c
analyses in pdf format are transmitted in the zip file. The e-mail text is in the local PHORESIS language
and in English).
 Improvement of the traceability of e-mails sent (log file for the sender).
 Option to delete the name of the patient in the advanced backup.
 Search by criteria: modification of the search for ID numbers to search for all or part of an ID.
 Statistics can be calculated from the QC backups.
 Table of control values: secured entry in the “Control name” field.
 Addition of maintenance operations in the data based from each automatic backup, in order to optimize
performances.
 No recording data when opening the cover during migration.
 New password proposed upon installation of the data base: by default “46448630Sebia!”.
 Conservation of the lot number of the hemolyzing solution upon technique changes on a CAPILLARYS 2
FLEX‐PIERCING.
 Possibility to disable automatic updating of the worklist.
 Recovery window: elimination of automatic recalculation of fractions when a sample is opened (CDT and Hb
technique).
 Resolution of curve browsing problems from the recovery window in the presence of suspended samples from
20,000 and problem of refreshing of the mosaic.
 The scan of the CSF ISOFOCUSING gel can now assign the results to the right patient after import via ASSIST
(barcodes of CSF and serum tubes are not imported into the worklist PHORESIS as 2 separate samples. These 2
barcodes are associated with the same sample in the worklist).
Page 68/70
IV. Qualification/Validation/Verification of this new release of PHORESIS
Operational Qualification of the PHORESIS release 8.60 is:

 to verify that the computer unit meets criteria for the proper functioning of this new release;
 to verify that the installation was successful;
 once installed, it works correctly with the equipment concerned.
This qualification must take into account the possible interferences with other softwares when the computer unit on which
PHORESIS is installed, is also used for other softwares. This qualification will also take into account the central informatics system
when it communicates with PHORESIS.
The analysis of reproducibility of quality control for techniques used can finalize the operational qualification of this new release.
A footnote on page shows the techniques for which it is necessary to make or remake a validation/verification as part of the
accreditation according to NF EN ISO 15189.
Page 69/70
Page 70/70

Main modifications to Phoresis software

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INFORMATION NOTE FOR USERS

A. HBA1C TECHNIQUE (CAPILLARYS 2 FLEX-PIERCING) ..................................................................................................................... 5

III. IMPROVED FUNCTIONALITIES ............................................................................................................................................ 68

IV. QUALIFICATION/VALIDATION/VERIFICATION OF THIS NEW RELEASE OF PHORESIS ...................................................... 69

A. Shared version for all SEBIA instruments

B. Urine Technique on CAPILLARYS 2 FLEX-PIERCING 1

C. IMMUNOTYPING URINE Technique on CAPILLARYS 2 FLEX-PIERCING 2

A. HbA1c technique (CAPILLARYS 2 FLEX-PIERCING)

1. Specific improvements to the calibration in the HbA1c technique

a) Ability to keep calibrations performed even if language is changed

c) Implementation of color codes on calibrations performed

d) Possible viewing of a calibrator profile

e) Management of calibrator lot number and/or concentration changes

 Either : “Calibration 'calibration ID' has not been successful.”

In worklist, click on the ID calibration brings up the window “calibration information”.

j) Modification of search parameters for A0 peak

The search windows have been refined:

2. Functional improvements specific to the HbA1c method

a) Warning in case of Hb A2 higher than 3%

b) Levey-Jennings HbA1c: visualization of the values of graph points

Search enabled by “atypical samples” and “with increased HbA1c value”.

h) CAPILLARYS HbA1c technique: Modification of minimum OD threshold for HbA1c controls

j) Securing of the HbA1c - Hb link

k) No transmission of profiles with red warning to central informatic

 Technique change enabled at startup.

 Technique change enabled at startup (same as 8.51).

1. Modification of zones titles and peaks identification (ID)

3. Deletion of the Hb AF control from the list of the controls

Zone No List of variants

10 Hb Nouakchott, Hb Wayne (peak 1), Hb M-Iwate (M-Kankakee), Hb Camden (Tokuchi), Hb Hope

5. Unmodifiable detection position of Hb A

6. Adjustment of the Hb A2 identification Template

4. Management of Flex and Non Flex modes

F. Several or all techniques

1. Transfer of flags on mosaic screen

2. HbA1c controls level 1 and level 2 defined as QC, by default

4. QC analysis with yellow, purple or red flags and statistics

 Implementation of a configurable printing (multiple printing):

10. Day’s worklist

11. Option to include testing not yet performed

12. Search by criteria

13. Removal of the note “Pathological”

15. Overlaying of the curves

1. Configuration of reagent barcodes on MINICAP and CAPILLARYS

Two types of reagent barcodes can be configured:

a) Case of a 12-character reagent ID

b) Case of a 14-character reagent ID:

J. MINICAP IMMUNOTYPING and IMMUNOTYPING URINE

L. Analysis counters on CAPILLARYS and MINICAP

(See After Sales Service for activation)

Thefollowing information is recorded:

Possibility of filtering by instrument, by analysis technique, by SAV or CLIENT mode.

Note: the information contained in this window can be sent by e-mail.

1. Positive identification is done using three independent steps

(1) Step 1/3 (ASSIST)

(2) Step 2/3 (HYDRASYS 2)

(3) Step 3/3 (GELSCAN)

3. Step 1/3 (ASSIST)

The green arrow indicates that the

After scanning, the barcode numbers

Sample barcodes are sent to the work

Barcodes are loaded in Modification of the first number of the