Gelletlie R, Nielsen J B
Clin Chem. 1986 Dec;32(12):2166-70.
We evaluated eight pregnancy tests: Tandem Icon, beta-hCG Rapid, Pregnastick (immunoenzymometric assays), Neo-Pregnosticon (direct hemagglutination), Pregnospia (sol particle immunoassay), Neo-Planotest (latex agglutination), Gravindex beta-hCG, and beta-hCG Slide Test (both latex-agglutination inhibition), all of which detect human choriogonadotropin (hCG) in urine. We investigated the limits of detection and the responses to the following substances: human lutropin, protein, and blood, and high concentrations of hCG. Using 100 patients' samples, we assessed the diagnostic specificity and sensitivity as well as the accuracy of each kit. The detection limits for Tandem Icon, beta-hCG Rapid, Neo-Pregnosticon, Pregnospia, Neo-Planotest, and Gravindex beta-hCG were as stated by the manufacturers. Only Neo-Planotest gave a false-positive result for lutropin. The three immunoenzymometric assays were not affected by protein or blood, but of these only Tandem Icon did not exhibit prozoning. The five other kits gave false-positive or false-negative results for protein and blood. Tandem Icon performed best, being quick and easy to use and without susceptibility to interfering substances.
我们评估了8种妊娠试验：串联式Icon、β-人绒毛膜促性腺激素快速检测法、孕棒（免疫酶比浊法）、新妊娠诊断试剂（直接血凝法）、妊娠诊断试纸（溶胶颗粒免疫测定法）、新普乐托检测试纸（乳胶凝集法）、妊娠指数β-人绒毛膜促性腺激素检测法以及β-人绒毛膜促性腺激素玻片检测法（均为乳胶凝集抑制法），所有这些方法均用于检测尿液中的人绒毛膜促性腺激素（hCG）。我们研究了这些方法的检测限以及对以下物质的反应：人促黄体生成素、蛋白质、血液和高浓度的hCG。我们使用100名患者的样本，评估了每个试剂盒的诊断特异性、敏感性以及准确性。串联式Icon、β-人绒毛膜促性腺激素快速检测法、新妊娠诊断试剂、妊娠诊断试纸、新普乐托检测试纸和妊娠指数β-人绒毛膜促性腺激素检测法的检测限如制造商所述。只有新普乐托检测试纸对促黄体生成素给出了假阳性结果。三种免疫酶比浊法不受蛋白质或血液的影响，但在这些方法中，只有串联式Icon未表现出前带现象。其他五种试剂盒对蛋白质和血液给出了假阳性或假阴性结果。串联式Icon表现最佳，使用快速简便，且不易受干扰物质的影响。
