Hepp H, Hoffmann G, Schlebusch H, Spona J, Keller M, Keller P J
Dtsch Med Wochenschr. 1976 Nov 5;101(45):1639-43. doi: 10.1055/s-0028-1104315.
In a multi-centre study 1117 morning urine samples were tested using the new immunochemical pregnancy tube test (Roche), based on the principle of indirect latex-agglutination inhibition. The test proved to be both qualitatively and semi-guantitatively suitable for demonstration of HCG in urine. There was only one false-negative result among 320 pregnancy tests (after 50th postmenstrual day). In 94 early pregnancies (test done before the 50th day) there were only two false-negative results. No false-positive result were seen. In the prognosis of threatened abortion, diagnosis of incomplete abortion, hydatid cyst, or chorionepithelioma the semiquantitative performance of the test was clinically useful and especially suitable because the result of the agglutination-inhibition reaction is unequivocal.
在一项多中心研究中,基于间接乳胶凝集抑制原理,使用新型免疫化学妊娠管检测法(罗氏公司)对1117份晨尿样本进行了检测。结果证明,该检测法在定性和半定量方面均适用于尿液中HCG的检测。在320例妊娠检测(月经后第50天之后)中仅有1例假阴性结果。在94例早期妊娠(检测在第50天之前进行)中仅有2例假阴性结果。未出现假阳性结果。在先兆流产的预后、不全流产、葡萄胎或绒毛膜上皮癌的诊断中,该检测法的半定量性能具有临床实用性,且特别适用,因为凝集抑制反应的结果明确。