ELISA检测HBsAg临界附近样本单一比对与复合检测结果分析

Comprehensive analysis of single comparison and composite detection on samples with HBsAg around ELISA cut-off value

目的 探讨酶联免疫吸附试验（ELISA）测定乙型肝炎表面抗原（HBsAg）阴性样本临界结果的复检范围和临界值以上弱阳性样本的复检范围,与电化学发光免疫法（ECLIA）定性检测比对以及乳胶免疫层析法二对半复合检测结果综合分析的意义.方法 血清样本用国产ELISA试剂测定HBsAg,阴性样本进行ELISA复检,临界附近样本进行ECLIA定性检测比对与乳胶免疫层析法二对半复合检测.结果 ELISA测定HBsAg临界附近样本存在一定程度的假阴（阳）性率;乳胶免疫层析法二对半复合检测在ELISA测定HBsAg 0.073 5≤A＜1.000的0.073 5≤A＜0.105一侧以Anti-HBs阳性682/1 020（66.86％）和全阴性345/1 020（33.82％）为主;而在0.105≤A＜1.000一侧主要是Anti-HBe或（和）Anti-HBc阳性329/333（包括36例HBeAg阳性者）（99.80％）.结论 ELISA检测HBsAg临界附近样本可以ECLIA定性检测比对验证;结合乳胶免疫层析法二对半复合检测结果综合分析可使绝大部分临界附近样本免做复检。

Objective To investigate the retesting borderline range of hepatitis B surface antigen （HBsAg） negative samples and the reexamination range of weakly positive samples above the critical value determined with enzyme-linked immunosorbent assay （ELISA）,and the performance of single comparison with electrochemiluminescence immunoassay （ECLIA） qualitative detection and two half-and-half composite detection with latex immunochromatographic assay.Methods Serum HBsAg was detected with ELISA reagents made in China.Negative samples were retested with ELISA.Samples with HBsAg around ELISA cutoff value were compared with ECLIA qualitative detection and two half-and-half detections of the borderline samples were made with latex immunochromatographic assay.Results HBsAg determination around ELISA cut-off value samples were of a certain degree of false negative （positive） rate.Anti-HBs positive 682/1020 （66.86%） and all negative 345/1020 （33.82%） in one side of 0.073 5≤ A 〈0.105 were found in two half-and-half examinations with latex immunochromatographic test,and in another 0.105 ≤ A 〈 1.000 side anti-HBe or/and anti-HBc positive 329/333 （including 36 cases with HBeAg positive） （99.80%） were major.Conclusions HBsAg ELISA borderline samples would be carried on qualitative detection with ECLIA as a comparison.If comprehensive analysis of two half-and-half examinations with latex immunochromatographic test were used,retesting of the most boardline samples would be omitted.