ASHI Quarterly

Third Quarter 2015

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36 ASHI Quarterly Third Quarter 2015 C O M M I T T E E A C T I V I T I E S QUESTION: On a PT sample, we detected low levels of DR51 and DR53 below the threshold we would assign these antigens as unacceptable for patients. However we received a discrepant grade for this sample for solid phase single antigen antibody detection since we didn't report DR51 and DR53 as positive (they came to 96 percent consensus). Our result for this sample was discrepant overall, as we did not report over 80 percent of the specificities that reached 90 percent consensus. We are supposed to treat PT samples the same as clinical samples, so what could we have done differently in this case? ANSWER: The committee understands the challenges of reporting "weak" antibodies Overall, since you stated that your validation documented that those antibodies at a weak MFI levels would not cause a positive crossmatch (information from the laboratory not shown here), and you followed your laboratory's written protocol for assigning positive antibody specificities, this information should be included in your internal corrective action report for inspection purposes A few suggestions that you might find helpful: • As stated in the instructions: "The specificities that they consider to be present at 'weak' levels, below their threshold for assignment, should be listed in the comments box Comments cannot be used for grading, and if those weak specificities reach consensus for positive, the results will be graded as discrepant However, the comments may be used to demonstrate appropriate performance to an accrediting agency " • If you have different cutoffs for calling positive single antigen specificities for the test versus what you call unacceptable antigens, for PT reporting you might consider reporting the antibodies that meet the threshold for positive For example, if UAs in UNET are ≥3000MFI, but positive test results are ≥1000MFI (such as for post-transplant monitoring or living- donor transplant cases), report the results >1000MFI for proficiency testing • PT programs offer a great opportunity for laboratories to review their results as compared to the results submitted by many other laboratories However, it is not the task of the PT program to challenge how a laboratory performs or interprets clinical tests; rather we attempt to offer a fair and consistent proficiency testing program that follows established grading criteria When appropriate, we recommend that laboratories seek further guidance from their accrediting agency Please note that the 2Q 2015 ASHI Quarterly addressed questions about the HT survey, and the FAQs can also be found on the ASHI Lab Center webpage We value your feedback and are still discussing the input that we received from our ASHI community colleagues in last year's survey We hope that you enjoy reading the PT summary reports and find the discussion of the antibody and crossmatch results and donor specific antibody details useful Thank you to the ASHI PT subscribers! We appreciate your participation, comments, and feedback. If you want to learn more about the ins and outs of proficiency testing, consider becoming a volunteer in 2016. If you are not already an ASHI PT subscriber and this article has caught your interest, please contact us for more information via Cecilia Blair, Director of Operations and our ASHI head office contact (cblair@ahint.com).

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