CAJ | 학술논문

目的：评价化学发光免疫分析法（CLIA）在梅毒实验室诊断中的应用。方法以酶联免疫吸附试验（ELISA）为相对标准，以明胶颗粒凝集试验（TPPA）为确证标准，收集2223份门诊和住院患者的血清标本，采用CLIA和ELISA法分别检测血清梅毒螺旋体抗体，并采用TPPA对检测结果进行确证，分析CLIA的检验效能。结果 2223份血清标本中，ELISA检测阳性53份，阳性率为2．34％；CLIA检测阳性60份，阳性率为2．70％；CLIA的阳性预测值为98．33％、检测灵敏度为100．00％、特异度为99．95％。结论 CLIA具有自动化、量化、检测周期短的特点。可用于实验室对梅毒螺旋体抗体的批量检测。
목적：평개화학발광면역분석법（CLIA）재매독실험실진단중적응용。방법이매련면역흡부시험（ELISA）위상대표준，이명효과립응집시험（TPPA）위학증표준，수집2223빈문진화주원환자적혈청표본，채용CLIA화ELISA법분별검측혈청매독라선체항체，병채용TPPA대검측결과진행학증，분석CLIA적검험효능。결과 2223빈혈청표본중，ELISA검측양성53빈，양성솔위2．34％；CLIA검측양성60빈，양성솔위2．70％；CLIA적양성예측치위98．33％、검측령민도위100．00％、특이도위99．95％。결론 CLIA구유자동화、양화、검측주기단적특점。가용우실험실대매독라선체항체적비량검측。
Objective To analyze the clinical performance of chemiluminescence immunoassay (CLIA)in determination of trepo‐nema pallidum antibody(TP antibody) .Methods The results detected by enzyme‐linked immunosorbent assay( ELISA)were regar‐ded as relative standards ,and results detected by treponema pallidum particle assay (TPPA) were regarded as recognition criteria . 2 223 serum samples of outpatients and inpatients were collected ,and TP antibodies were detected by CLIA and ELISA method re‐spectively ,and followed by confirmation of TPPA test .Results Among 2 223 serum samples ,53 samples were TP antibody positive detected by ELISA and 60 samples were TP antibody positive detected by CLIA ,and the positive incidence of TP antibody detected by the ELISA and CLIA method was 2 .34% and 2 .65% respectively .The positive predictive value ,sensitivity and specificity of the CLIA method was 98 .33% ,100 .00% and 99 .95% ,repectively .Conclusion The CLIA method could be considered adequate for screening of TP antibody in a large volume of samples ,with characteristics of automatic ,quantitative and short turn around time .