The original studies were performed by adding increasing concentrations of purified hCGβcf to a urine sample obtained from a pregnant woman. The problem with this approach is that the relative abundance of hCG, hCGβcf and other hCG variants in the urine that may affect device performance vary between women. A standardized method, using defined concentrations of hCG, is needed to evaluate the performance of currently available devices.
In a recent publication, we describe a screening method that can be easily used to examine the effect of hCGβcf and have used this method to test eleven POC hospital urine hCG devices.
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Examination of eleven hospital hCG devices for false negative results
Source: The Pregnancy Lab