Addendum to HLA Fusion IVD User Manual v3.0

Addendum to HLA Fusion IVD User Manual v3.0
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ADDENDUM
USER MANUAL
Addendum to
User Manual
HLA Fusion™ Software, Version 3.X.X
For In Vitro Diagnostic Use
2012/03
P. 103
Addition of clarifying text prior to Manual Allele Code Assignment section. Section now reads:
The NMDP condensing rules HLA Fusion software utilizes to present the allele pairs in the Possible
Allele Code field when the NMDP Code option is enabled are based on NMDP requirements. The
NMDP may change these condensing rules periodically, and due to the nature of their timing HLA
Fusion software may not be synchronized 100% with the newer NMDP condensing rules. Hence, in
some cases, the codes may not match and NMDP may reject the coded results. The Possible Allele
Code displays suggested software analysis results and user should verify and make appropriate
changes to the Assigned Code field prior to exporting the file for NMDP submission. Risk: None;
Mitigation: Perform a manual update to the exported file.
Manual Allele Code Assignment
1. Type an assignment into the text field just below Assigned Allele Code. Make sure you type
the assignment in correct allele code format:

The new nomenclature format: X*##:##(####) X*##:##(####), where X = locus type and # =
code number).

The previous nomenclature format: X*#### X*####, where X = locus type and # = code
number).
Otherwise, Fusion will not accept it and prompts you to make corrections.
P. 162-163 & 167
Deletion of references to CREG bar in CREG Bar section on page 167 and Find Antigen section on
pages 162-163 . Find Antigen section now reads:
Find Antigen
Enter single or multiple antigens to circle the antigen(s) on the specificity, (center) area of the
analysis window.
1. From the analysis window, type antigens, separated by a space, into the field next to the
Find Ag
(Antigen) button. The antigen strings you type in must match the antigen
displayed on the window.
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HLAF-MAN-v3x.x-EN-02, Rev 0
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One Lambda, Inc. | User Guide Addendum: HLA Fusion v3.X.X User Manual
Click the Find Ag
Note:
button to circle the entered antigens.
If the antigen entered is a broad antigen, then its split antigens will be circled. For
example, if A9 is entered, then A23 and A24 will be circled.
P. 168
Deletion of reference to Reanalyze button in Saving Assignments section. Section now reads:
Saving Assignments
Lab technicians and supervisors can save analysis results for further review and approval. Saved
samples are available for confirmation only by a lab supervisor.

From the analysis window, click the Save
button, located at the bottom right corner
of the analysis window to save analysis results for all the specificities currently listed in the
Final Assignments field.
After clicking the Save button, Fusion automatically moves you to the next sample.
For confirmation, a supervisor needs to access the sample for which you saved the assignments. You
can return to the sample any time prior to confirmation if you need to make changes.
HLAF-MAN-v3.x.x-EN-02, Rev 0
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One Lambda, Inc. | User Guide Addendum: HLA Fusion v3.X.X User Manual
REVISION HISTORY
Revision
Date
0
2014/02
HLAF-MAN-v3.x.x-EN-02, Rev 0
Revision Description
Original release
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