Barlow R D, Thompson S G, Cuckle H S, Wald N J, Voller A
Ann Clin Biochem. 1986 May;23 ( Pt 3):334-9. doi: 10.1177/000456328602300315.
An enzyme-linked immunosorbent assay (ELISA) was evaluated for serum alpha-fetoprotein determination in the antenatal screening for fetal open neural tube defects. The ELISA was used concurrently with an existing radioimmunoassay (RIA) method until serum specimens from 5000 pregnant women, between 15 and 20 weeks gestation, had been tested. The accuracy of the ELISA was similar to that of the RIA; the median AFP values by gestational week obtained with the ELISA were, on average, 2 KIU/L higher than the corresponding RIA values; the 10th and 90th percentiles, in terms of multiples of the median (MoM), were very similar. The precision of the two methods was also similar. The ELISA method yielded 1.8% results from unaffected pregnancies above 2.5 MoM compared with 1.4% by RIA, a small but statistically significant difference (P = 0.03). Both methods detected the same affected pregnancies identified during this period; five open neural tube defects, three with exomphalos and three intra-uterine deaths. The ELISA method was simple, required about one quarter less operator time than the RIA and enabled results to be generated in one day rather than the two days required by RIA. The ELISA method is a suitable alternative to RIA for routine use in screening for fetal neural tube defects.
在胎儿开放性神经管缺陷的产前筛查中，对一种用于测定血清甲胎蛋白的酶联免疫吸附测定法（ELISA）进行了评估。在对5000名妊娠15至20周孕妇的血清标本进行检测之前，ELISA法与现有的放射免疫测定法（RIA）同时使用。ELISA法的准确性与RIA法相似；ELISA法按孕周得出的甲胎蛋白中位数，平均比相应的RIA值高2 KIU/L；以中位数倍数（MoM）表示的第10和第90百分位数非常相似。两种方法的精密度也相似。ELISA法得出1.8%未受影响妊娠的结果高于2.5 MoM，而RIA法为1.4%，差异虽小但具有统计学意义（P = 0.03）。两种方法在此期间检测出的受影响妊娠相同；5例开放性神经管缺陷，3例脐膨出和3例宫内死亡。ELISA法操作简单，所需操作人员时间比RIA法少约四分之一，且能在一天内得出结果，而RIA法则需要两天。ELISA法是RIA法用于胎儿神经管缺陷筛查常规使用时的合适替代方法。
