Derouin F, Garin Y J, Buffard C, Berthelot F, Petithory J C
Universités-Praticien hospitalier, Hôpital Saint-Louis, Paris, France.
Bull World Health Organ. 1994;72(2):249-56.
A collaborative study conducted by the French National Agency for Quality Control in Parasitology (CNQP) and various manufacturers of ELISA kits, represented by the Association of Laboratory Reagent Manufacturers (SFRL) compared the toxoplasmosis IgG antibody titres obtained with different ELISA-IgG kits and determined the relationships between the titres obtained by these techniques and the titre defined in international units (IU). Fifty-one serum samples with toxoplasmosis antibody titres ranging from 0 to 900 IU were tested in two successive studies with 16 ELISA-IgG kits. For the negative sera, false-positive reactions were observed with one kit. For the positive sera, the titres observed in ELISA were generally higher than those expressed in IU. Above 250 IU, the very wide variability of the titres found with the different ELISA kits renders any comparative analysis impossible. For titres below 250 IU, the results are sufficiently homogeneous to permit the use of regression analysis to study how the results for each ELISA kit compare with the mean results for the other kits. The slope of the line of regression shows a tendency to over-titration or under-titration compared with the results of the other manufacturers; the ordinate at the origin reflects the positivity threshold of the reaction and can be used to assess the risk of a lack of sensitivity (high threshold) or of specificity (threshold too low). On the whole, the trends revealed for a given manufacturer are constant from one study to the other. Within this range of titres, regression analysis also reveals the general tendency of ELISA kits to overestimate the titres by comparison with immunofluorescence.(ABSTRACT TRUNCATED AT 250 WORDS)
由法国国家寄生虫学质量控制机构(CNQP)与以实验室试剂制造商协会(SFRL)为代表的各种ELISA试剂盒制造商合作开展的一项研究,比较了使用不同ELISA-IgG试剂盒获得的弓形虫IgG抗体滴度,并确定了这些技术获得的滴度与国际单位(IU)定义的滴度之间的关系。在两项连续的研究中,使用16种ELISA-IgG试剂盒对51份弓形虫抗体滴度在0至900 IU之间的血清样本进行了检测。对于阴性血清,有一种试剂盒出现了假阳性反应。对于阳性血清,ELISA中观察到的滴度通常高于以IU表示的滴度。在250 IU以上,不同ELISA试剂盒发现的滴度差异极大,无法进行任何比较分析。对于低于250 IU的滴度,结果足够均匀,可使用回归分析来研究每种ELISA试剂盒的结果与其他试剂盒的平均结果相比情况如何。回归直线的斜率显示出与其他制造商的结果相比有过滴定或滴定不足的趋势;原点处的纵坐标反映了反应的阳性阈值,可用于评估缺乏敏感性(高阈值)或特异性(阈值过低)的风险。总体而言,给定制造商显示出的趋势在一项研究到另一项研究中是恒定的。在这个滴度范围内,回归分析还揭示了与免疫荧光相比ELISA试剂盒普遍存在高估滴度的趋势。(摘要截选至250词)