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2010 Ask the FDA and CLIA Transcript
Ask the FDA and CMS/CLIA
October 11, 2010
AABB 2010 Annual Meeting
Baltimore, Maryland
FDA
Jay Epstein - Director, Office of Blood Research & Review, CBER
Ellen Lazarus - Director, Division of Human Tissues in the Office of Cells, Tissue and Gene Therapy, CBER
Hira Nakhasi - Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research & Review, CBER
Paul Mied - Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research & Review, CBER
Judy Ciaraldi - Consumer Safety Officer, Division of Blood Applications, Office of Blood Research & Review, CBER
Lore Fields - Consumer Safety Officer, Blood & Plasma Branch, Division of Blood Applications, Office of Blood Research & Review, CBER
Sharon O'Callaghan - Program Surveillance Branch, Office of Compliance & Biologics Quality, CBER
CMS
Penelope Meyers - Division of Laboratory Services, Survey & Certification Group, Center for Medicaid & State Operations at CMS
Moderator
M. Allene Carr-Greer, Director, Regulatory Affairs, AABB
Question 4: We perform all routine testing using gel technology. We also perform electronic crossmatches. For patients in whom clinically significant antibodies have been identified, is it sufficient to perform only a gel antiglobulin crossmatch? Does this satisfy the CLIA requirement to perform a test to detect ABO incompatibility?
MS. MEYERS: For this question, before I start, I would like to just make the comment that the answers that I will be giving to the questions today are based on the CLIA regulations. However, I would like to remind the audience that many laboratories choose to obtain their CLIA certification through a CMS-approved accreditation organization, of which there are six. One of which is AABB. These laboratories must follow all the requirements of their chosen accreditation organization which may be more stringent than the CLIA requirements.
Now back to the question. Actually, these CLIA requirements for crossmatching are based on the FDA requirements for crossmatching, and FDA and CMS have collaborated in preparing the answer to this question. The simple answer is that the IgG gel card does not fulfill the requirement to demonstrate ABO incompatibility. There are two issues involved here. First, the labeling clearly indicates that the IgG gel card is for direct and indirect antiglobulin tests. In other words, detection of cell-bound IgG antibodies. While the limitation section of the package insert states that some IgM antibodies may react, this limitation should not be interpreted to mean that the card is capable of detecting all IgM antibodies, particularly ABO antibodies. Secondly, the IgG gel card is a low ionic test system and there have been reports that ABO incompatibilities, due to IgM antibodies, can be missed when the antibodies are weak and the test is low ionic strength. While we acknowledge that there is continuing debate on this topic, but with the knowledge of these reports and in the absence of data from the reagent manufacturer to support the use of a low ionic strength system for detection of ABO incompatibility due to IgM antibodies, we believe it is not appropriate for users to omit some kind of test to detect these incompatibilities. And for eligible patients, an electronic crossmatch would fulfill the requirements. An immediate spin crossmatch, of course, is an acceptable method for all patients.
MODERATOR: Thank you, Penny. Can I ask, because I could not hear everything that you just said, but did you respond to the part about sufficient to perform only the gel antiglobulin crossmatch, that first part?
MS. MEYERS: No, it is not sufficient to perform only the gel antiglobulin crossmatch because that does not fulfill the requirement to detect ABO incompatibilities.
PANEL MEMBERS:
Eagle01 reacted to Dansket in AABB Standards 5.15 CrossmatchThe following reference may be pertinent to your question: