Wallace E M, Crossley J A, Ritoe S C, Aitken D A, Spencer K, Groome N P
Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, Victoria, Australia.
Ann Clin Biochem. 1998 Sep;35 ( Pt 5):656-64. doi: 10.1177/000456329803500510.
The development of a sensitive and specific enzyme-linked immunoassay (ELISA) for inhibin A stimulated the observation that inhibin A was a useful prenatal marker of Down's syndrome. Modifications of that ELISA, in terms of preassay sample treatment, detection methods and standard preparation, were subsequently introduced to improve assay performance and reduce costs. These modified formats have been validated and reported. We describe the modifications in detail, explaining the rationale for each, and report the results of a study directly comparing the various ELISA formats in terms of assay performance when applied to clinical samples and ability to differentiate between normal and Down's syndrome pregnancies. A format involving sample pretreatment with sodium dodecylsulphate at 100 degrees C was found to give better assay performance and a modest improvement in discrimination between Down's syndrome samples and controls, and we recommend this format for use by other investigators.
用于抑制素A的灵敏且特异的酶联免疫吸附测定（ELISA）的开发促使人们观察到抑制素A是唐氏综合征有用的产前标志物。随后在分析前样品处理、检测方法和标准品制备方面对该ELISA进行了改进，以提高检测性能并降低成本。这些改进后的形式已经过验证并已发表报告。我们详细描述了这些改进，解释了每项改进的原理，并报告了一项研究的结果，该研究直接比较了各种ELISA形式在应用于临床样本时的检测性能以及区分正常妊娠和唐氏综合征妊娠的能力。发现一种在100℃下用十二烷基硫酸钠进行样品预处理的形式具有更好的检测性能，并且在区分唐氏综合征样本和对照方面有适度改善，我们推荐这种形式供其他研究人员使用。
