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Dear POCT colleagues

Jan Still (21 June) quoted a paper in Am J Clin Path about a US study that
found problems with interference in the pCO2 results (Jan's email repeated
below).  There was a response to the paper from Abbott explaining that the
problem was caused by an interfering substance in a particular batch of
syringes folowing a change in manufacturing process. It's in Am J Clin
Pathol (2000) Nov114(5):821-3.  (There's no abstract on Medline so I have
summarised it.)

The problem only occurred with whole blood but could be reproduced
predictably when they investigated it in detail.  Once identified it was
resolved in collaboration with the syringe manufacturer.  The letter does
not state what the problem was, but I assume all users would be informed if
there was a possibility of a recurrence with a different manufacturers.
Ironically one potential advantage of i-Stat is that you don't have to use
specific blood gas syringes.

The problem was picked up at the time by some other US hospitals and solved
by changing syringes. As it was a problem with the syringes it would not be
detected by the electronic simulator.  It's unfortunate that the
interference did not show up with QC materials. No substitute for 'reality
testing' by humans at the bedside, as always with POCT!  Parallel sampling
would have picked this up.

A case for routine acceptance testing of syringes by POCT teams?

Hope this helps

Richard Taylor






Hi Richard,

Thanks for the information. The article is
"The rise and fall of i-Stat" Am J Clin Path
114(1):128-38, Jul 2000

The article says that i-Stat was chosen as a cost
saving exercise when they wished to close their ITU
hot lab. Their use spiralled and costs were huge. The
most worrying problem was clinically significant
discrepant values for PCO2 which would have resulted
in altered patient treatment.The errors were not noted
with either QC or QA material or the electronic
checks, but were evident with blood samples.As they
could not identify a cause, and fearful of litigation
or adverse patient event the whole system was
scrapped.

I also have a paper Clin Chem 47(11):2064-6,2001 Nov
which refers to discrepant chloride values with
samples with elevated ureas.

Regards Jan