Porres J M, D'Ambra C, Lord D, Garrity F
Am J Clin Pathol. 1975 Oct;64(4):452-63. doi: 10.1093/ajcp/64.4.452.
The results obtained with eight pregnancy kits on 735 urines were compared. Overall accuracies were similar and fairly high (93.4 to 95.37%), although only 78.28% of all pregnancies were simultaneously detected by all eight kits. It is suggested that the different performances of each kit could be accounted for not only by lack of product homologation, differences in kit sensitivity, and laboratorian error, but also by the presence of various hormonal components in various concentrations in the urines of pregnant women, and by the presence of different antibodies against these hormonal components in various concentrations in the antisera included in the various kits.
对8种妊娠检测试剂盒检测735份尿液样本的结果进行了比较。总体准确率相似且相当高(93.4%至95.37%),尽管所有8种试剂盒同时检测出的妊娠样本仅占全部妊娠样本的78.28%。研究表明,每种试剂盒表现不同的原因,不仅可能是缺乏产品认证、试剂盒灵敏度差异和实验室人员操作误差,还可能是孕妇尿液中存在各种浓度的不同激素成分,以及各种试剂盒所含抗血清中存在不同浓度的针对这些激素成分的不同抗体。