10种弓形虫IgG抗体检测试剂盒的评价

Evaluation of 10 kits for detecting IgG antibodies of Toxoplasma gondii

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。

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（9positive 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 coinci- dence to positive reference panel or negative reference panel and detection limit with the national refer- ence panel of anti-Toxophasma IgG serum samples. Results Among ten kits, seven diagnostic kits for [gG antibodies to Toxophasma （ELISA） met the requirements of the national reference panel of anti- Toxophasma 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.