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)
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