Date sent: Fri, 1 Jun 2001 09:36:13 +0100
Send reply to: "Hyde Philip (ULHT)" <[log in to unmask]>
From: "Hyde Philip (ULHT)" <[log in to unmask]>
Subject: Urine pregnancy testing on automated immuno-analysers
To: [log in to unmask]
I do not want to comment specifically on assays for urinary hCG,
as I do not know which ones have been validated by their
manufacturers, although I am sure that Philip's implication is
correct.
However, the issue in general is, I believe, clear. If a laboratory
uses an analytical system for any purpose for which it is not
supported fully by its manufacturer, then full responsibility for the
results produced lies with the laboratory. This is potentially a very
important matter, that is not appreciated by many laboratories.
Who within a laboratory could be said to be personally responsible,
I know not, but someone would have to stand up in court in the
event of a disaster.
A specific example I came across recently arose in the UK
NEQAS for screening for Down's syndrome. I will not identify the
manufacturer and assay for fear of ending up in court myself, but a
particular hCG assay suddenly started to give much higher values
than previously. Some laboratories with a low workload for Down's
screening had immense trouble adjusting their medians to
compensate for the increase in concentrations. The hCG assay is
NOT supported by the manufacturer for use in screening for Down's
syndrome. The manufacturer is happy to admit that the
concentrations in pregnancy serum have increased, and has a
pretty good idea why, but is unwilling to take any urget action,
simply because the kit is being used "off label".
I appreciate that laboratories may be tied to one platform for all of
their assays but they must be aware of the potential for litigation if
they use assays for purpose for which they are unsupported,
Andy Ellis
> Dear All,
> I notice from perusal of EQAS returns that some laboratories are
> apparently using automated serum HCG assays for urine pregnancy
> testing. This seems to me to be an interesting point, as the
> manufacturer's of the kits/analysers may not have validated the kits
> for this purpose. If they haven't, isn't this a significant risk
> issue? Who has product liability? We have been tempted for some time
> to use our Elecsys HCG for pregnancy tests but have been dissuaded
> from doing so because of this perceived risk. If a laboratory does a
> full method evaluation anyway and concludes that it is safe to analyse
> urines, where do they stand medico-legally m'luds ?
>
> Philip Hyde,
> Pilgrim Hospital,
> Boston (UK)
Andy Ellis
Scheme Manager
UK NEQAS for Peptide Hormones
Royal Infirmary
Edinburgh EH3 9YW
Tel : +44 (0)131 536 2763
Fax : +44 (0)131 536 2765
Email : [log in to unmask]
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