Johnson Sarah, Eapen Saji, Smith Peter, Warren Graham, Zinaman Michael
a SPD Development Company Ltd. , Bedford , United Kingdom.
b Jacobi Medical Center , Department of Obstetrics and Gynecology , Bronx , New York , USA.
J Immunoassay Immunochem. 2017;38(4):449-455. doi: 10.1080/15321819.2017.1329152. Epub 2017 May 19.
Very high levels of β-core fragment human chorionic gonadotrophin (βcf-hCG) are reported to potentially cause false negative results in point-of-care (POC)/over-the-counter (OTC) pregnancy tests. To investigate this further, women's daily early morning urine samples, collected prior to conception and during pregnancy, were analysed for intact, free β-, and βcf-hCG. The proportion of βcf-hCG was found to be related to that of hCG produced and in circulation. Therefore, best practice for accuracy testing of POC/OTC pregnancy tests would be to test devices against clinical samples containing high levels of βcf-hCG as well as standards spiked with biologically relevant ratios.
据报道，极高水平的β-核心片段人绒毛膜促性腺激素（βcf-hCG）可能会导致即时检验（POC）/非处方（OTC）妊娠试验出现假阴性结果。为了进一步研究这一问题，对受孕前和怀孕期间收集的女性每日晨尿样本进行了完整、游离β-和βcf-hCG分析。结果发现，βcf-hCG的比例与产生并循环的hCG比例相关。因此，POC/OTC妊娠试验准确性测试的最佳做法是针对含有高水平βcf-hCG的临床样本以及添加了生物学相关比例的标准品对检测设备进行测试。
