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《International Journal of Laboratory Medicine》 2010-06
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Analysis of Positive Blood Donors from NAT Screening:Comparison with ELISA Tests

ZEN Jin-feng,LI Huo,XU Xiao-xun,et al. (The Clinical Laboratory of Shenzhen Blood Centre 518035,China)  
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".
【Fund】: 深圳市科技局立项课题(200803116)
【CateGory Index】: R457.1
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