青岛地区63846份无偿献血者血液标本筛查结果分析

Analysis of screening results of 63846 blood donors in Qingdao area

目的分析ELISA检测HBsAg、抗-HCV、抗-HIV和抗-TP初、复检及再检结果的符合情况及核酸检测结果,探讨2种检测方法在血液筛查降低病毒漏检中的作用。方法对2012年10月-2013年5月青岛市中心血站采集的63 846人份无偿献血者标本采用ELISA检测方法对血液传染性指标HBsAg、抗-HCV、抗-HIV、抗-TP进行检测,采用Roche Cobas S201血液筛查系统对ELISA检测无反应性及单试剂反应性的60 483份标本进行HBV、HCV和HIV 3项联合筛查,并对核酸检测阳性标本进行拆分单检及病毒型别鉴定。结果 63 846份标本中ELISA检测及ALT不合格人数共1 273例,不合格率为2.0%。初检试剂的HBsAg和抗-TP的再检率明显高于复检试剂,而抗-HCV、抗-HIV的再检率在初复检间无明显差异,同项目初、复检试剂反应重复率差异均有统计学意义。60 483份标本共检出NAT阳性43例,其中ELISA无反应性41例,检出率为0.068%,单试剂反应性2例,经鉴定33例为HBV DNA,未检出HCV RNA和HIV RNA。结论现行ELISA检测模式存在病毒漏检风险,通过病毒核酸检测能够缩小这种风险的概率,NAT与ELISA的血液筛查检测呈互补作用,2种方法联合应用可有效降低病毒漏检,提高输血安全。

Objective To analyze the results of first and second round tests of HBsAg, anti-HCV,anti -HIV and anti -TP by ELISA and the results of nucleic acid amplification test （NAT） in order to estimate the two kinds of detection methods in missing of the virus detection. Methods From October,2012 to May,2013 ,a total of 63 846 blood units collected from donors were screened for the serological markers as HBsAg,anti-HCV, anti-HIV, and anti-TP. NAT was performed using Roche Cobas TaqScreen MPX assay,which can simultaneously detect HIV 1 （groups M and O）, HIV-2, HCV, and HBV on Roche Cobas s201 system. NAT-reactive donations were further evaluated by real-time polymerase chain reaction using Cobas Am- pliPrep/CobasTaqMan hepatitis B virus,hepatitis C virus and human immunodeficiency virus tests. Results A total number of 1 273 cases were unqualified in 63 846 samples; the unqualified rate was 2%. The re-test rate of initial inspection reagent of HBsAg and anti-TP was significantly higher than that of the second reagent. And the re-test rate of anti-HCV, anti-HIV showed no significant differences. The reaction repetition rate of the same test items had statistical difference between the initial and second test. A total number of 60 483 samples were screened in which 43 samples were reactive,41 were missed by ELISA,and 2 were single reagent reactive with the positive rate of 0.068%. The NAT identified 33 cases of HBV-DNA;however, HCV-RNA and HIV-RNA were not detected. Conclusion Based on the seroprevalence study of HIV, HBV and HCV, we conclude that screening of blood and blood components by dual testing strategy using serological assay and NAT helps in detecting the potential infections of blood units, which aids in enhancing the blood safety and reducing the potential risk of post-trausfusion infection.