胶体金免疫层析法急诊检测HBsAg漏检风险评价

目的评价胶体金免疫层析法(简称胶体金法)急诊检测乙型肝炎表面抗原(HBsAg)的漏检风险。方法新疆生产建设兵团医院2014年急诊手术前或急诊侵入性检查前胶体金法检测HBsAg患者3 887例,检测结果经酶联免疫吸附试验(ELISA)验证。采用胶体金法和ELISA检测4个浓度水平HBsAg质控品,评价检测方法灵敏度。以ELISA检测结果为参照,评价胶体金法的漏检风险。结果胶体金法检测HBsAg的灵敏度为2~4IU/mL,ELISA检测灵敏度小于或等于0.5IU/mL。患者标本胶体金法和ELISA检测结果比较差异有统计学意义(P0.05)。ELISA结果阳性而胶体金法检测结果为阴性的相对风险为0.003 91(95%CI:0.002 318~0.006 597)。ELISA检测的标本光密度与临界值的比值(S/CO)为15.314~21.210时,可初步估计胶体金法检测结果。结论在急诊手术前或急诊侵入性检查前采用胶体金法检测HBsAg存在漏检风险,应引起实验室和临床的关注。

Risk assessment of false-negative results for HBsAg in emergency patients by colloid gold-immunochromatography assay

Objective To evaluate the risk of false‐negative results for HBsAg in emergency patients by colloid gold‐immuno‐chromatography assay(GICA) .Methods HBsAg detected results by GICA in 3 887 patients before emergency operation or invasive examination were collected from Hospital of Xinjiang Production and Construction Corps in 2014 ,and were also verified by enzyme‐linked immunosorbent assay(ELISA) .Four concentration levels of HBsAg control materials were detected by GICA and ELISA to evaluate detection sensitivity .The risk of false‐negative results for HBsAg by GICA was evaluated in comparison with ELISA .Re‐sults Detection sensitivities of GICA and ELISA for HBsAg were 2-4 IU/mL and louer than 0 .5 IU/mL ,respectively .There was significant difference of the HBsAg results by GICA and ELISA (P<0 .05) .When ELISA was regarded as control assay ,the rela‐tive risk of negative HBsAg results by GICA but positive results by ELISA was 0 .003 91(95% CI:0 .002 318 -0 .006 597) .The range of S/CO value between 15 .314 and 21 .210 could be used to estimate the negative or positive results by GICA .Conclusion The risk of false‐negative HBsAg results by GICA before emergency operation or emergency invasive examination should be paid attention in clinical laboratories and medical staffs .