化学发光法检测TORCH抗体方法学评价.docVIP

化学发光法检测TORCH抗体方法学评价 　　[摘 要] 目的：评价化学发光法检测TORCH抗体的价值。方法：样本来自1829名孕前及孕早期妇女，应用酶联免疫吸附法、化学发光法依次检测其TORCH特异性免疫球蛋白M（IgM）抗体阳性率，比较两种检测方法的重复性及灵敏度。结果：化学发光法检测TORCH各病原体IgM的阳性率均高于酶联免疫吸附法，差异有统计学意义（P0.05）。随着标本稀释倍数的增加，两种方法检测TORCH抗体的阳性率均逐渐下降，酶联免疫吸附法阳性率下降更为明显，差异有统计学意义（P0.05）。结论：化学发光法检测TORCH抗体的批内、批间重复性良好且阳性率与灵敏度更高，对于TORCH感染的早期检测具有推广价值。 　　[关键词] 化学发光法；TORCH抗体；方法学评价；免疫球蛋白M 　　中图分类号：R446 文献标识码：A 文章编号：2095-5200（2017）03-077-03 　　DOI：10.11876/mimt201703032 　　[Abstract] Objective： This study objective was to evaluate the value of chemiluminescence in the detection of TORCH antibodies. Methods： The sample came from 1 829 pregnant women and early pregnant women， the positive rate of TORCH-specific immunoglobulin M （IgM） antibody was detected by enzyme-linked immunosorbent assay （ELISA） and chemiluminescence method. The reproducibility and sensitivity of the two methods were compared. Results： The positive rate of IgM in each pathogen of TORCH detected by chemiluminescence method was higher than that by enzyme-linked immunosorbent assay， and the difference was statistically significant （P0.05）. With the increase of the dilution ratio， the positive rate of TORCH antibody was decreased gradually， and the positive rate detected by enzyme-linked immunosorbent assay was decreased significantly （P0.05）. Conclusions： The batch-to-batch reproducibility by the method of chemiluminescence for the detection of TORCH antibody is good and its positive rate and sensitivity are higher， which is of great value for early detection of TORCH infection. 　　[Key words] chemiluminescence method； TORCH antibody； methodological evaluation； immunoglobulin M 　　TORCH是一组具有致畸作用的病原微生物的缩写，孕妇感染的TORCH可沿胎盘播散至胎儿，并导致新生儿发育迟缓、畸形等多种并发症[1]。通过检测血清中TORCH特异性免疫球蛋白M（IgM）抗体明确THRCH感染状态，对保证母婴结局、改善人口质量具有重要意义[2]。既往临床常用的TORCH抗体检测手段为酶联免疫吸附法，但该技术灵敏度偏低且需手工操作，无法满足临床快速诊断和筛查要求[3]。本研究就化学发光法检测TORCH的临床价值进行了方法学评。 　　1 资料与方法 　　1.1 一般资料 　　2010年2月―2016年2月来我院进行产前筛查或产检1829名孕前及孕早期女性，排除既往有自然流产、早产、死胎、胎儿畸形等不良孕产史者。其中孕前女性713名，年龄20～39岁，平均（26.25±4.31）岁；孕早期女性1116名