血清学检测与核酸检测在献血者血液筛查中的相关性研究

Correlation between serological assay and nucleic acid testing in screening donated blood for transfusion

目的评价血清学检测与核酸检测在降低输血相关风险中的相关性。方法对大连市血液中心2012年12月1日-2013年5月31日共计33 708份献血者标本同时进行血清学检测(HBsAg、HCV抗体、HIV抗原/抗体、梅毒特异性抗体、谷丙转氨酶)和HBV/HCV/HIV三联核酸定性检测。单纯核酸检测反应性的标本需进行鉴别试验,对鉴别阴性的献血者进行跟踪检测。将HBsAg、HCV抗体、HIV抗原/抗体三项酶联免疫检测与核酸检测结果对比分析。结果酶联免疫检测单试剂不合格率为1.38%。酶联免疫检测双试剂反应性而核酸检测无反应性的不合格标本有40份,其中HBsAg反应性12份,HCV抗体反应性28份。单纯核酸检测反应性标本有46份,经鉴别和追踪确认HBV感染献血者15例,HIV窗口期感染1例,无HCV RNA的检出。结论核酸检测对于血清学阴性的HBV感染检出效果明显;但对于感染了HBV但病毒载量极低的献血者,核酸检测存在漏检的可能;血液筛查中核酸检测不能代替血清学检测;慎重对待核酸检测的假阳性结果,制定合理的献血者评估策略以减少献血者流失。

Objective To evaluate the correlation between serological testing and nucleic acid testing （NAT） in reducing the risk of transfusion- transmitted infections. Methods We performed serological testing for screening HBsAg, anti - HCV, HIV antigen and anti - HIV antibodies, syphilis antibody and alanine aminotransferase and simultaneously conducted multiplex NAT for detection of HBV, HCV and HIV on 33,708 blood donors＇ blood in Dalian Blood Center collected between December 1, 2012 and May 31, 2013. The samples only reactive in NAT were further distinguished and the screen - negative blood donors were followed up. The screening results of serological testing and NAT for HBsAg, anti - HCV, HIV antigen and anti - HIV an- tibodies were compared. Results The unqualified rate of single ELISA kit was 1.38 %. There were 40 unqualified samples re- active in double ELISA kits but non - reactive in NAT, of which 12 were reactive for HBsAg and 28 reactive for anti - HCV. 46 samples were reactive only in NAT, from which 15 HBV- infected blood donors and 1 HIV- infected donor during the window period were identified by follow- up testing. No HCV- RNA positive donors were detected. Conclusions NAT contributes obviously to screening blood donors with negative HBV serological indicators, but NAT may fail to detect HBV infection with low virus load. NAT technology can not replace serological assay for screening blood donors. It is important to carefully deal with the false- lx）sitive results of NAT and formulate appropriate evaluation strategies for blood donation so as to retain blood donors.