CAJ | 학술논문

目的对10种弓形虫IgG抗体检测试剂盒(酶联免疫法)进行质量评价. 方法弓形虫IgG抗体检测试剂用参考血清国家参考品24份,其中9份为阳性参考品,15份为阴性参考品.10种弓形虫IgG抗体检测试剂盒中,5种为国产试剂盒,5种为进口试剂盒.用国家参考品对弓形虫IgG抗体检测试剂盒进行检测,检验项目包括阳性参考品符合率、阴性参考品符合率和最低检出量. 结果 10种试剂盒中,7种符合弓形虫IgG抗体检测试剂用参考血清国家参考品的要求；2种国产试剂盒的阳性参考品符合率分别为8/9、6/9,出现假阴性；1种进口试剂盒的阴性参考品符合率为12/15,出现假阳性. 结论大部分弓形虫IgG抗体检测试剂盒能符合国家参考品的要求,少数试剂盒则需要提高敏感性.
목적 대10충궁형충IgG항체검측시제합(매련면역법)진행질량평개. 방법 궁형충IgG항체검측시제용삼고혈청국가삼고품24빈,기중9빈위양성삼고품,15빈위음성삼고품.10충궁형충IgG항체검측시제합중,5충위국산시제합,5충위진구시제합.용국가삼고품대궁형충IgG항체검측시제합진행검측,검험항목포괄양성삼고품부합솔、음성삼고품부합솔화최저검출량. 결과 10충시제합중,7충부합궁형충IgG항체검측시제용삼고혈청국가삼고품적요구；2충국산시제합적양성삼고품부합솔분별위8/9、6/9,출현가음성；1충진구시제합적음성삼고품부합솔위12/15,출현가양성. 결론 대부분궁형충IgG항체검측시제합능부합국가삼고품적요구,소수시제합칙수요제고민감성.
Objective To evaluate the quality of ten diagnostic kits for detecting IgG antibodies against Toxophasma (ELISA).Methods There was the national reference panel of 24 anti-Toxophasma IgG serum samples(9 positive samples,15 negative samples).Differences of ten diagnostic kits(5 domestic and 5 import) for detecting IgG antibodies against Toxophasma (ELISA) were compared for their coincidence to positive reference panel or negative reference panel and detection limit with the national reference panel of anti-Toxophasma IgG serum samples.Results Among ten kits,seven diagnostic kits for IgG antibodies to Toxophasma (ELISA) met the requirements of the national reference panel of antiToxophasma IgG serum.There were false negatives in the two domestic kits,with coincidence to positive reference panel of 8/9 and 6/9.And there was false positive in one import kit,with negative reference panel coincidence of 12/15.Conclusion Most of the diagnostic kits for IgG antibodies to Toxophasma (ELISA) met the requirements of the national reference panel of anti-Toxophasma IgG serum.The sensitivity of a few kits for diagnosis of toxoplasmosis should be further boosted.