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目的分析酶联免疫吸附试验(ELISA)和核酸检测(NAT)筛查血液HBV/HCV/HIV感染的结果。方法对绍兴市2015年1月—2016年2月采集的52 339份无偿献血者血液标本进行谷丙转氨酶(ALT)检测,并采用2家不同公司生产的ELISA试剂(A/B)进行HBs Ag、梅毒、HCV抗体、HIV抗体检测,排除ALT和梅毒阳性标本后进行HBV/HCV/HIV核酸检测。结果共有52 228份标本用ELISA和NAT作平行检测。以NAT检测结果为金标准,HBV检测阳性169份,阳性率3.24‰;A试剂灵敏度为55.62%,特异度为99.95%;B试剂灵敏度为59.76%,特异度为99.97%。HCV检测阳性11份,阳性率0.21‰;A试剂灵敏度为100.00%,特异度为99.83%;B试剂灵敏度为100.00%,特异度为99.93%。HIV检测阳性5份,阳性率0.10‰;A试剂灵敏度为80.00%,特异度为99.98%;B试剂灵敏度为80.00%,特异度为99.95%;A、B试剂均有1例窗口期漏诊。结论 ELISA联合NAT检测可进一步提高血液病毒检测结果的准确性。
Objective To analyze the results of blood HBV / HCV / HIV infection by enzyme-linked immunosorbent assay (ELISA) and nucleic acid assay (NAT). Methods The blood samples of 52 339 blood donors collected from January 2015 to February 2016 in Shaoxing were tested for alanine aminotransferase (ALT), and HBsAg was detected using two different ELISA reagents (A / B) , Syphilis, HCV antibody, HIV antibody test, excluding ALT and syphilis positive specimens for HBV / HCV / HIV nucleic acid detection. Results A total of 52 228 specimens were tested in parallel with ELISA and NAT. The NAT detection results as the gold standard, HBV test positive 169, the positive rate of 3.24 ‰; A reagent sensitivity was 55.62%, specificity was 99.95%; B reagent sensitivity was 59.76%, specificity was 99.97%. The positive rate of HCV was 0.21 ‰. The sensitivity of A reagent was 100.00% and the specificity was 99.83%. The sensitivity and specificity of B reagent were 100.00% and 99.93% respectively. HIV test positive 5, the positive rate of 0.10 ‰; A reagent sensitivity was 80.00%, specificity of 99.98%; B reagent sensitivity was 80.00%, specificity of 99.95%; A, B reagents have a window missed diagnosis. Conclusion The ELISA combined with NAT can further improve the accuracy of blood test results.