献血者乙型肝炎病毒筛查结果分析

Analysis on hepatitis B virus screening results in blood donors

目的通过对HBsAg阳性而核酸检测(NAT)结果阴性的血液标本进行HBsAg确认检测,以评估不同检测策略的优劣,以期为降低HBV输血感染风险和建立科学有效的献血者屏蔽归队策略提供科学依据。方法采用2种ELISA试剂进行无偿献血者的HBsAg筛查,同时用TMA技术进行HBV DNA检测,将ELISA法HBsAg阳性但TMA法HBV DNA阴性的血液标本进行HBsAg中和确证实验和乙肝血清学标志物(HBV-M)检测。结果在47 004份标本中,共检出226份HBsAg阳性且HBV DNA阴性的标本。对其中161份标本进行了HBsAg中和确证实验,43份确证阳性,确证阳性中2种ELISA试剂均阳性占37份,ELISA试剂1单阳性标本和ELISA试剂2单阳标本各为3份,其确证阳性率分别为3.7%、9.1%。ELISA法单试剂检测HBsAg阳性结果的比例占到了HBsAg不合格血液标本的70%,但ELISA试剂1和ELISA试剂2的假阳性率分别高达96.3%和90.9%。对血液检测模式进行了筛查效果的评估,"1遍NAT+1遍ELISA"筛查模式检出率为0.094%,"2遍ELISA"筛查模式检出率为0.017%,二者比较有显著性差异。对133份进行了HBsAg中和确证实验的标本实施了乙肝血清学标志物(HBV-M)两对半检测,抗-HBs、抗-HBe、抗-HBc在ELISA结果阳性的不同情况中,其阳性比例呈现不同趋势,抗-HBc阳性率最高。结论 "1遍NAT+1遍ELISA"筛查策略比原有"2遍ELISA"筛查策略更能保障血液安全。由ELISA假阳性导致的献血者被错误屏蔽的问题,需要我们建立献血者归队策略,并制订科学有效的检测步骤和流程。

Objective To evaluate different blood test strategies through confirming whether if the blood samples were HB-sag positive and HBV-DNA negative, and to provide evidence for the establishment of an effective strategy of deferral and reentry of blood donors. Methods All blood samples from blood donors were screened for HBsAg by imported and domestic ELISA kits and also HBV-DNA by TMA technique. Then, the blood samples that were HBsAg positive and HBV-DNA negative were determined by HBsAg confirmatory test and serological markers of hepatitis B （HBV-M）. Results From 47 004 blood samples, 226 blood samples positive for HBsAg and negative for HBV-DNA were detectedby ELISA and TMA technique, respectively. They were screened ont. 161 blood samples underwent further HBsAg confirmatory test and 43 were tested HBsAg positive. Among the 43 samples positive for HBsAg, 37 were positive tested by both ELISA reagents, 3 were positive only by reagent 1, and 3 were positive only by reagent 2. For the two ELISA reagents, the positive rates of confirmatory test were 3.7% and 9.1%, respectively. Samples that were confirmed positive for HBsAg by only one of the two EL1SA reagents accounted for 70%. The false positive rates of HBsAg for reagents 1 and 2 were 96.3% and 90.9%, respectively. The efficacy of blood screening strategies was evaluated. The detection rate of ＂one NAT and one ELISA＂ was 0.094% while the detection rate of ＂ two ELISAs＂ reached 0.017%. There was a significant difference. The results of detection of three other hepatitis serological markers, from the 133 HBsAg confirmed samples, showed the different trends in the positive rates of HBsAb, HBeAb and HBcAb. The HBcAb positive rate was the highest. Conclusion The strategy of ＂one NAT and one ELISA＂ for blood screening is better than that of ＂two ELISAs. ＂ A scientific and effective blood screening system should be set up for the establishment of a strategy to defer and reenter blood donors.