快速甲型/乙型流感抗原筛查试验与H1N1 PCR检测结果的比较与评价

Detection and analysis of influenza A and B antigen screening test and H1N1 PCR assay results

目的分析比较甲型/乙型流感快速筛查试验与H1N1PCR确证试验结果之间的相关性,为H1N1型流感的快速筛查提供依据。方法采用胶体金免疫层析法甲型/乙型流感检测试剂盒与北京朝阳区疾病预防控制中心的PCR确证方法同时测定87例具有相关体征病人的鼻咽部拭子,确定病人流感病毒的感染状况。结果自2009年6月至2009年9月,我院送检H1N1型流感检测标本248例。其中我院实验室同时用胶体金免疫层析法甲型/乙型流感检测试剂盒筛查测定87例,甲型流感病毒阳性标本15例,乙型流感病毒阳性0例。87例病人中,H1N1阳性标本9例;快速筛查试验与确证试验两种方法同时阳性6例;同时阴性69例。筛查试验阳性而确证试验阴性的标本9例;筛查试验阴性而确证试验阳性的标本3例。筛查试验对甲型H1N1流感病毒的阳性预示值为40.0%,阴性预示值为95.8%。诊断灵敏度是66.7%,诊断特异性是88.5%。结论胶体金免疫层析法甲型/乙型流感快速检测试剂盒可作为甲型H1N1流感病毒的筛查实验,但有一定的局限性,可作为诊断的初步依据。

Objective To analyze the relation of influenza A and B antigen on rapid screening test and H1N1 PCR assay for clinical rapid diagnosis.Methods Nasal-pharyngeal swabs from 87 patients with flu-like symptom were detected for influenza A and B antigen by rapid colloid gold chromatographic immunoassay,and H1N1 antigen by PCR assay.Results From June to September,2009,248 specimens were detected for H1N1 antigen.Of 248 samples,87 were tested by rapid screening method.Among the 87 specimens,15 were influenza A antigen positive,none of specimens was influenza B positive,and H1N1 were detected in 9 specimens.6 spec-imens were positive in both of rapid screening test and PCR assay,69 were negative by both methods;Rapid screening test positive but PCR assay negative specimens were 9,3 specimens were negative in rapid screening test but got positive results with PCR assay.The positive predictive value to influenza A-H1N1 of screening test was 40.0%,and with 95.8% of negative predictive value.Sensitivity of screening test was 66.7%,with 88.5% of specificity.Conclusions The colloid gold chromatographic immunoassay flu A and B rapid test can be used as type A H1N1 flu virus antigen screening test,and it can provide early diagnostic evidence even though has some limitations on that purpose.