核酸检测阳性标本与酶联免疫吸附试验分析研究

目的为了提高临床输血的安全性,拟比较血液筛查核酸检测(NAT)阳性标本结果与酶联免疫吸附试验(ELISA)数据分析,旨在研究探讨如何提高ELSIA检测技术在血液筛查中的灵敏度。方法对55 499例常规ELISA检测非反应性的无偿献血者血样标本,其各项指标均正常的标本,用NAT检测技术8例混合检测,从中比较NAT检测阳性与酶联免疫吸附试验结果。结果血清学检测非反应性标本中11例HBV DNA阳性标本,1例HCV RNA阳性标本,HIV RNA未检出。结论 NAT与ELISA的血液筛查检测互补作用主要体现在3个方面:1)窗口期漏检是目前ELISA漏检的最大因素。2)免疫静默感染、病毒变异、病毒亚型对以抗原-抗体免疫反应技术基础的ELISA方法会降低ELISA检测性能。3)ELISA检测"灰区"的设置在理论上可以减少因试剂检测灵敏度而造成的漏检现象,但仍无法解决因病毒变异、病毒亚型和因"窗口期"而造成的漏检现象。

Analysis of Positive Blood Donors from NAT Screening: Comparison with ELISA Tests

Objective To improve the safety in blood transfusion,a comparison between positive nucleic acid test(NAT)screening results and ELISA test results was carried out to study how to elevate the test sensitivity in ELISA blood screening.Methods Apply NAT test in 8-sample minipool to 55 499 donor plasma samples that were collected from January 1,2008 to March 31.2009 and were non-reactive in ELISA blood screening tests.Analyze the ELISA results from NAT positive samples.Results Among 55 499 ELISA non-reactive samples,we detected 11 HBV-DNA positive,1 HCV-RNA positive,none HIV-RNA positive.Conclusion NAT and ELISA complement to each other in 3 aspects.1)Window-period false-negative is the main cause in current ELISA false-negatives.2)Immuno silent infections,viral mutations,viral subtypes can reduce the analytical performance of antibodyantigen immunoreaction based ELISA test.3)The establishment of"gray-zone"in ELISA result interpretations can decrease the false-nagatives caused by sensitivity of the tests,however,it does not resolve the false-negatives from viral mutations,subtypes and "window periods".