The AACC Clin Lab Strategies Vol 9 Nov 2004 report on "Finding the Cause of
Recent Immunoassay Interferences" in their highlighted box state "To date,
approximately eight immunoassays on platforms manufactured by four different
companies appear to be affected. This represents a very small subset of the
100+immunoassays being tested to-day, but BD, manufacturers, and
laboratories have collaborated closely to quickly find the problem and
address it". Such a statement completely trivialises the seriousness of the
problem, the unknown impact it had on patient care, and the lack of support
for laboratories who were affected. We were BD gel tube users for a long
time, so something changed in the tubes, which appears to have occurred at
an unspecified date, ? late 2003. We were informed of interference with
specified methods by DPC in July 2004, followed shortly after by Bayer, and
have to thank the manufacturers for this. We had to notify all users of our
service that we had possibly issued incorrect results for T3 for at least 6
months, which must affect the users confidence in their laboratory (FSH
interference was highlighted later). We did not have resources to withdraw
tubes, and I think BD should have done this. We had to find an alternative
supplier of gel tubes, and send out replacement tubes to users. The "very
small subset of 100+ immunoassays" affected are frequently used assays and
not rare infrequent assays.
____________________________________________________________
Dr. Helen Grimes, Dept. of Clinical Biochemistry, UCH, Galway, Ireland
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