I agree that this has been a serious issue.
We confirmed that B12 and folate were, on average, about 20% high in
the faulty tubes
and followed the advice issued by the Medicines and Healthcare Products
Regulatory Authority.
We asked our users to use gel-free tubes for the affected assays and
to consider
re-testing individuals on whom we had reported borderline low values.
B-D, however, can't tell me exactly when the problem started.
We now have some "reformulated" SST tubes; but it has been our staff,
not BD's, who have had
to re-call the faulty tubes. Within our hospital this has meant
visiting every clinical area to seek out
and destroy the faulty tubes.
I think this problem has lead to some lack of confidence in our
results: a GP this morning asked me
if the unexplained high potassium on her patient could be due to a
faulty tube. (I don't think so).
Ideally the manufacturers should quality control their tubes before
release by checking them on the popular analytical platforms.
Wayne Bradbury.
Mr. W.H. Bradbury
Consultant Biochemist
Cumberland Infirmary
CARLISLE
CA2 7HY
Telephone: 01228 814521
Facsimilie: 01228 814831
E-mail: [log in to unmask]
>>> <[log in to unmask]> 09/12/04 10:00:13 >>>
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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