用于沙眼衣原体IgM抗体准定量测定的酶联免疫吸附法的验证

A. Besarab, V. Motronenko, E. Bespalova, I. Nastenko
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引用次数: 0

摘要

以下研究的目的是代表基于ELISA样品对沙眼衣原体特异性igm抗体进行半定量的血清体外诊断手段验证程序的科学性和方法学基础。验证特性(精密度、诊断和分析特异性、诊断灵敏度、相对线性)在诊断集发布之初和截止日期(作为稳定性研究的要素)都进行了定义。诊断敏感性和特异性的值,通过过程中的血清集(20个阳性和50个阴性)定义为100%。样品中其他种类衣原体抗体的存在不影响ELISA检测特异性IgM抗体的结果。该方法线性良好。结果的测定内变异在3.1% ~ 6.4%之间,测定内精密度在1.5% ~ 8.4%之间,在释放时和有效期内均可接受(≤10%)。验证了ELISA方法,诊断试剂盒在1年内是稳定的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
VALIDATION OF THE ENZYME-LINKED IMMUNOSORBENT ASSAY FOR EMIQUANTITATIVE DETERMINATION OF IgM ANTIBODIES AGAINST CHLAMYDIA TRACHOMATIS
The object of the following study is representation of the scientific and methodical foundation of the procedure of validation of means of serum in vitro diagnosis basing on the sample of ELISA for semiquantification of specific Chlamydia trachomatis IgM-antibodies. Validation characteristics (precision, diagnostic and analytic specificity, diagnostic sensitivity, relative linearity) were defined both at the beginning of the release of diagnostic set and the expiration date (as the element of stability study). The values of diagnostic sensitivity and specificity, defined via the in-process set of serums (20 positive and 50 negative) comprised 100%. The presence of other classes of Chlamydia antibodies in samples didn’t influence the results of ELISA for specific IgM antibodies. Linearity of the method was sufficient. The intra-assay variation of results is between 3.1% to 6.4%, and intra-assay precision was from 1.5% to 8.4%, staying acceptable (≤ 10%) both at the moment of release and during expiration date. The ELISA method is validated, and the diagnostic kit is regarded as stable during 1 year.
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