Kasper David C, Prusa Andrea R, Hayde Michael, Gerstl Nicole, Pollak Arnold, Herkner Kurt R, Reiter-Reisacher Rosmarie
Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria.
J Clin Microbiol. 2009 Jan;47(1):164-7. doi: 10.1128/JCM.01435-08. Epub 2008 Nov 5.
Infection with Toxoplasma gondii is often asymptomatic and, when acquired during pregnancy, may lead to connatal toxoplasmosis in the offspring. The newly introduced Vitros anti-Toxoplasma immunoglobulin G (IgG) and IgM assays, designed for the Vitros ECiQ immunodiagnostic system, a fully automated system based on chemiluminescence, were evaluated as a screening method for the serological detection of acute and chronic Toxoplasma infections in the sera of 719 pregnant women. The combination of the Vitros IgG and IgM assays demonstrated a sensitivity and a specificity of 100% for the successful detection of all acute T. gondii infections by comparison with the Sabin-Feldman dye test as the reference test. The Vitros IgG assay parameter revealed a sensitivity of 95.0%, a specificity of 100.0%, a positive predictive value of 100.0%, a negative predictive value of 86.2%, and an overall agreement of 96.2% by comparison with the dye test. Comparison of the Vitros Toxoplasma IgM assay with the immunosorbent agglutination assay yielded values of 77.1%, 99.0%, 97.7%, 88.5%, and 91.1%, respectively. Subsequent receiver operating characteristic curve analysis for the accurate detection of Toxoplasma IgM in acute (n = 90) and chronic (n = 461) infections demonstrated high sensitivity (92.2%) and specificity (81.6%). The combination of a Toxoplasma-specific IgG assay with specific IgM antibody detection has improved the diagnosis of T. gondii infection by decreasing follow-up testing. Nonetheless, positive Toxoplasma IgM test results during pregnancy necessitate confirmatory testing by a reference laboratory to ensure fast and, above all, accurate test results.
感染弓形虫通常没有症状，若在孕期感染，可能会导致子代先天性弓形虫病。新推出的用于Vitros ECiQ免疫诊断系统的Vitros抗弓形虫免疫球蛋白G（IgG）和IgM检测试剂，该系统是基于化学发光的全自动系统，被评估作为一种筛查方法，用于检测719名孕妇血清中急性和慢性弓形虫感染的血清学情况。与作为参考检测的Sabin-Feldman染色试验相比，Vitros IgG和IgM检测试剂联合使用时，成功检测出所有急性弓形虫感染的灵敏度和特异性均为100%。与染色试验相比，Vitros IgG检测试剂参数显示灵敏度为95.0%，特异性为100.0%，阳性预测值为100.0%，阴性预测值为86.2%，总体一致性为96.2%。Vitros弓形虫IgM检测试剂与免疫吸附凝集试验相比，各项值分别为77.1%、99.0%、97.7%、88.5%和91.1%。随后针对急性（n = 90）和慢性（n = 461）感染中准确检测弓形虫IgM的受试者工作特征曲线分析显示，其具有高灵敏度（92.2%）和特异性（81.6%）。将弓形虫特异性IgG检测与特异性IgM抗体检测相结合，通过减少后续检测，改善了弓形虫感染的诊断。尽管如此，孕期弓形虫IgM检测结果呈阳性时，仍需要参考实验室进行确证检测，以确保检测结果快速且最重要的是准确。
