Wilson M, Remington J S, Clavet C, Varney G, Press C, Ware D
Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30341, USA.
J Clin Microbiol. 1997 Dec;35(12):3112-5. doi: 10.1128/jcm.35.12.3112-3115.1997.
As a result of reports received by the Food and Drug Administration (FDA) of false-positive results obtained with FDA-cleared in vitro diagnostic kits for the detection of Toxoplasma-specific human immunoglobulin M (IgM) antibodies, an FDA-sponsored evaluation of six kits was performed. A battery of 258 serum specimens, including 30 specimens drawn 1 to 5 months after initial Toxoplasma infection and 228 specimens from Toxoplasma IgG-positive individuals, Toxoplasma IgG-negative individuals, rheumatoid factor-positive persons, and persons determined to be Toxoplasma IgM positive by commercially available assays, was assembled, randomly assorted, and coded. The battery was tested at the FDA with six commercially available kits, at the Palo Alto Medical Foundation (PAMF) by the PAMF double-sandwich IgM enzyme-linked immunosorbent assay (PAMF IgM ELISA), and at the Centers for Disease Control and Prevention (CDC) by the CDC EIA IgM. The results of the PAMF IgM ELISA that were obtained with the battery were considered to be the "gold standard" for this study; specificity rates were computed by considering the PAMF results to be 100% specific. Sensitivity and specificity rates were found to be as follows: CDC EIA IgM, 100 and 99.1%, respectively; Abbott IMx Toxo IgM, version 1, 100 and 77.5%, respectively; Abbott IMx Toxo IgM, version 2, 93.3 and 97.3%, respectively; Abbott Toxo-M EIA, 100 and 84.2%, respectively; BioMérieux Vitek VIDAS Toxo IgM, 100 and 98.6%, respectively; BioWhittaker Toxocap-M, 100 and 95.9%, respectively; Gull Toxo IgM, 97 and 85.6%, respectively; and Sanofi Diagnostics Pasteur Platelia Toxo IgM, 100 and 96.8%, respectively. Although the extent of false-positive reactions with these kits cannot be calculated because the study was retrospective and sample choices were biased, the results may be useful as an indicator of the relative specificities of these kits.
由于美国食品药品监督管理局（FDA）收到报告称，经FDA批准的用于检测弓形虫特异性人类免疫球蛋白M（IgM）抗体的体外诊断试剂盒出现假阳性结果，FDA发起了一项对六种试剂盒的评估。收集了一组258份血清标本，其中包括30份在初次感染弓形虫后1至5个月采集的标本，以及228份来自弓形虫IgG阳性个体、弓形虫IgG阴性个体、类风湿因子阳性者和经市售检测方法确定为弓形虫IgM阳性者的标本，将其随机分类并编码。该组标本在FDA使用六种市售试剂盒进行检测，在帕洛阿尔托医疗基金会（PAMF）通过PAMF双夹心IgM酶联免疫吸附测定法（PAMF IgM ELISA）进行检测，并在疾病控制与预防中心（CDC）通过CDC EIA IgM进行检测。该组标本用PAMF IgM ELISA获得的结果被视为本研究的“金标准”；通过将PAMF结果视为100%特异性来计算特异性率。发现灵敏度和特异性率如下：CDC EIA IgM分别为100%和99.1%；雅培IMx弓形虫IgM第1版分别为100%和77.5%；雅培IMx弓形虫IgM第2版分别为93.3%和97.3%；雅培弓形虫-M EIA分别为100%和84.2%；生物梅里埃Vitek VIDAS弓形虫IgM分别为100%和98.6%；BioWhittaker Toxocap-M分别为100%和95.9%；Gull弓形虫IgM分别为97%和85.6%；以及赛诺菲诊断巴斯德公司的Platelia弓形虫IgM分别为100%和96.8%。尽管由于该研究是回顾性研究且样本选择存在偏差，无法计算这些试剂盒假阳性反应的程度，但这些结果可能有助于作为这些试剂盒相对特异性的指标。
