常州市中心血站HBV 筛查中酶联免疫检测与核酸检测结果 不一致的分析  

Analysis of the inconsistency between ELISA and NAT in HBV screening in Changzhou Blood Center

作　　者：董珀 何亚琴[1] 濮云峰[1] DONG Po;HE Yaqin;PU Yunfeng(Texting Laboratory,Changzhou Blood Center,Changzhou Jiangsu 213000,China)

机构地区：[1]常州市中心血站检测中心,江苏常州213000

出　　处：《临床与病理杂志》2020年第6期1357-1362,共6页Journal of Clinical and Pathological Research

摘　　要：目的:调查常州地区无偿献血者HBV筛查中ELISA HBsAg阴性/核酸扩增检测(nucleic acid amplification detection technology,NAT)HBV DNA阳性的情况,确保输血安全。方法:经2种不同的ELISA试剂检测合格的献血者标本,采用罗氏或者科华核酸检测系统检测HBV DNA,HCV RNA,HIV RNA的6人份混合样本(POOL),混样阳性的POOL再进行拆分检测,采用化学发光的方法对拆分阳性的标本检测乙肝标志物5项,并对所检出乙肝标志物5项结果全为阴性的血液进行追踪。结果:48635份2遍ELISA阴性的献血者标本混检11016个POOL,混检阳性的POOL数为66个,经拆分为HBV DNA阳性的POOL数为40个,未检出HCV RNA和HIV RNA,NAT总有效拆分率为60.61%,NAT检测出的标本阳性率为0.08%。针对上述HBV DNA阳性的血液,用化学发光再次检测乙肝5项,有7份标本五项全阴;其余为6份抗-HBs^+、6份抗-HBs^+/抗-HBc^+、4份抗-HBs^+/抗-HBe^+、7份抗-HBc^+/抗-HBe^+、10例抗-HBc^+。追踪其中4份乙肝5项检测结果全阴的血液,HBsAg均由阴性转为阳性。结论:NAT能在ELISA阴性的标本中筛检出HBV DNA阳性的标本,减少窗口期乙肝和隐匿性乙肝的发生,进一步保证了血液的安全。ELISA HBsAg阴性/NAT HBV DNA阳性的献血者中以隐匿性乙肝为主,为输血残余风险的主要隐患。Objective:To analyze the inconsistency between enzyme-linked immunosorbent assay(ELISA)HBsAg-negative and nucleic acid amplification assay(NAT)HBV DNA positive in HBV screening of unpaid blood donors in Changzhou,and further ensure the safety of blood transfusion.Methods:The qualified blood donor samples tested by two different ELISA reagents were further tested by the Roche or Kehua nucleic acid detection system for detecting HBV DNA,HCV RNA and HIV RNA in 6 mixed blood samples,and the positive POOLs were separated and detected.The specimens with positive segregation were tested by chemiluminescence for detection of 5 markers of hepatitis B,and the blood with 5 negative results was traced.Results:A total of 48635 ELISAnegative blood donor samples tested for 2 times were mixed with 11016 POOLs.The number of positive POOLs was 66 in the mixed test,and the number of POOLs that were split into HBV DNA positive was 40.No HCV RNA and HIV RNA were detected.The total effective resolution rate of NAT is 60.61%,and the positive rate of specimens detected by NAT is 0.08%.For the above-mentioned HBV DNA-positive blood,the five markers of hepatitis B were all negative in 7 cases by chemiluminescence;6 cases of anti-HBs^+,6 cases of anti-HBs^+/anti-HBc^+,4 cases of anti-HBs^+/anti-HBe^+,7 cases of anti-HBc^+/anti-HBe^+,and 10 cases of anti-HBc^+.Four negative cases were traced,and HBsAg in all these four turned from negative to positive.Conclusion:NAT can screen HBV DNA-positive specimens in ELISA-negative specimens,reduce the incidence of window period hepatitis B infection and occult hepatitis B infection,further ensure blood safety.The investigation shows that ELISA HBsAgnegative/NAT HBV DNA-positive blood donors were mainly occult hepatitis B virus infection,which was the main risk of residual blood transfusion.

关 键 词：核酸扩增检测技术 HBV DNA 窗口期 隐匿性乙肝病毒感染 

分 类 号：R51[医药卫生—内科学]