Holman D J, Rasheed F N, Stroud C M, Brindle E, O'Connor K A, Campbell K L
Department of Anthropology, Pennsylvania State University, University Park 16802, USA.
Clin Chim Acta. 1998 Mar 9;271(1):25-44. doi: 10.1016/s0009-8981(97)00225-8.
We describe simple modifications to the ICON II hCG (URINE) pregnancy test to provide a sensitive and specific urinary assay for hCG in field studies of fetal loss. The modified assay had a qualitative lower limit of detection of 0.30 IU/l, a 50% qualitative limit of 0.61 IU/l, a 100% qualitative limit of 1.16 IU/l, and a quantitative limit of 0.80 IU/l. Coefficients of variation ranged from 9.9% to 21.1%. Parallelism was observed among serially diluted subject samples. We used the assay in an 11-month prospective study of fetal loss in rural Bangladesh in which urine samples were collected twice-weekly from 494 women; 330 pregnancies and 93 fetal losses were detected. The median time to a positive pregnancy diagnosis was day 26 from last menses. The modified assay provided qualitative detection of early pregnancy comparable to laboratory assays, and appears to be well suited for use in epidemiologic or rural-population fetal loss studies.
我们描述了对ICON II hCG（尿液）妊娠试验的简单改进，以在胎儿丢失的现场研究中提供一种灵敏且特异的hCG尿液检测方法。改进后的检测方法定性检测下限为0.30 IU/l，50%定性限为0.61 IU/l，100%定性限为1.16 IU/l，定量限为0.80 IU/l。变异系数范围为9.9%至21.1%。在系列稀释的受试者样本中观察到了平行性。我们在孟加拉国农村进行的一项为期11个月的胎儿丢失前瞻性研究中使用了该检测方法，在此研究中，每周两次从494名妇女中收集尿液样本；检测到330例妊娠和93例胎儿丢失。妊娠诊断呈阳性的中位时间是自末次月经起第26天。改进后的检测方法对早期妊娠的定性检测与实验室检测相当，似乎非常适合用于流行病学或农村人群胎儿丢失研究。
