Inappropriate use of commercial human chorionic gonadotropin assays.

نویسنده

  • Hugh Mitchell
چکیده

I am disappointed that the recent Q&A article in Clinical Chemistry dealing with assays for human chorionic gonadotropin (hCG) did not mention that all commercial hCG assays in the US are FDA cleared only for the early detection of pregnancy (1 ). The current situation is very unsatisfactory, because these assays, with the knowledge of the manufacturers, are in widespread use for oncology. What is perhaps not widely known is that in the event of litigation for the reporting of an incorrect result obtained by off-label use of the kit, the responsibility lies with the user, not the manufacturer, because the insert clearly states that the assay is suitable only for the early detection of pregnancy. Evidence for failure of commercial 2-site assay hCG detection methods to detect disease-related forms of hCG has been reported (2, 3).

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عنوان ژورنال:
  • Clinical chemistry

دوره 56 5  شماره 

صفحات  -

تاریخ انتشار 2010