电化学免疫发光分析法联合核酸检测定量法在ELISA HBsAg-/NAT+血液样本中的应用价值

目的分析电化学免疫发光法(ECLIA)联合核酸检测(NAT)定量法在ELISA HBsAg-/NAT+血液样本检测中的应用价值。方法选择血站采集的无偿献血者血液样本22843例,酶联免疫吸附法(ELISA)检测为乙型肝炎表面抗原(HBsAg)阴性的血液样本行NAT检测,先行混合检测,后行拆分检测。选取拆分检测为初检ELISA HBsAg-/NAT+的血液样本行NAT定量检测,NAT定量检测为阳性的血液样本进一步行ECLIA联合NAT定量检测。结果经ELISA检测,22843例血液样本中HBsAg阳性65例,HBsAg阴性22778例。将ELISA检测为HBsAg阴性的22778血液样本进一步行NAT检测,经混合检测,27个混样池为阳性;经拆分检测,29例血液样本呈HBV-DNA阳性。对29例初检ELISA HBsAg-/NAT+血液样本进一步行NAT定量检测,阳性率为65.52%(19/29),其中5例HBV-DNA病毒载量≥20 IU/mL,14例HBV-DNA病毒载量<20 IU/mL。19例ELISA HBsAg-/NAT+血液样本经ECLIA检测,HbsAg、HBeAg全阴,HBsAb阳性3例(15.79%),HBeAb阳性7例(36.84%),HBcAb阳性15例(78.95%),血清模式为全阴5例(26.32%),单纯HBcAb阳性7例(36.84%)。19例ELISA HBsAg-/NAT+血液样本经ECLIA联合NAT定量检测,4例处于窗口期,15例处于隐匿性感染期。结论血站血液样本初检中存在一定的漏检现象,NAT检测可在大量ELISA阴性样本中快速筛检出HBV-DNA阳性标本,ECLIA联合NAT定量检测可帮助献血者明确自身HBV感染状态,值得临床应用和推广。

Application value of electro-chemiluminescence immunoassay combined with nucleic acid test quantitative method in ELISA HBsAg-/NAT+blood samples

Objective To analyze the application value of electro-chemiluminescence immunoassay(ECLIA)combined with nucleic acid test(NAT)quantitative method in enzyme linked immunosorbent assay(ELISA)for HBsAg-/NAT+blood samples.Methods A total of 22843 blood samples were collected from voluntary blood donors in blood stations.The blood samples with negative HBsAg detected by ELISA were detected by NAT,mixed detection first,and then split detection.The split detected were used for NAT quantitative test in blood samples with ELISA HBsAg-/NAT+,and the blood samples with positive NAT were further detected by ECLIA combined with NAT quantitative test.Results By ELISA detection,65 cases were HBsAg positive and 22778 cases were HBsAg negative in 22843 blood samples.A total of 22778 HBsAg negative blood samples by ELISA were further detected by NAT,after mixed detection,27 mixed sample pools were positive;after split detection,29 blood samples were positive of HBV-DNA.Twenty-nine blood samples of initial ELISA HBsAg-/NAT+were further detected by NAT quantitative,the positive rate was 65.52%(19/29),the viral load of HBV-DNA≥20 IU/mL in 5 cases and<20 IU/mL in 14 cases.Nineteen blood samples of ELISA HBsAg-/NAT+by ECLIA detection,HBsAg and HBeAg were all negative,HBsAb was positive in 3 cases(15.79%),HBeAb was positive in 7 cases(36.84%),HBcAb was positive in 15 cases(78.95%),serum pattern was all negative in 5 cases(26.32%),simple HBcAb was positive in 7 cases(36.84%).Nineteen blood samples of ELISA HBsAg-/NAT+tested by ECLIA combined with NAT quantitative test,4 cases was in the window period,15 cases was in the latent infection period.Conclusion There is a certain phenomenon of missing detection in the initial examination of blood samples in blood stations.NAT can quickly screen out HBV-DNA positive samples from a large number of negative ELISA samples.ECLIA combined with NAT quantitative test can help blood donors to identify their own HBV infection status.