Comparative performance of ISAGA IgM and ELISA assays for the diagnosis of maternal and congenital Toxoplasma infections: which technique could replace ISAGA IgM?

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS
ACS Applied Bio Materials Pub Date : 2024-01-01 Epub Date: 2024-02-08 DOI:10.1051/parasite/2024004
Anne-Sophie Deleplancque, Hélène Fricker-Hidalgo, Christelle Pomares, Coralie L'Ollivier, Jean-Philippe Lemoine, Bernard Cimon, Luc Paris, Sandrine Houzé, Isabelle Villena, Hervé Pelloux, Odile Villard
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引用次数: 0

Abstract

The ISAGA immunocapture test for the detection of anti-Toxoplasma immunoglobulin M is a manual technique known for its excellent sensitivity and specificity. The purpose of this retrospective, multicenter study was to compare the performances and agreement between ISAGA and other IgM detection techniques before cessation of ISAGA production. The analytic performance of the different tests was evaluated using 1,341 serum samples from adults with positive IgM and negative IgG to Toxoplasma gondii, and 1,206 sera from neonates born to mothers with seroconversion. The agreement between the tests was evaluated on 13,506 adult and 5,795 child serum samples. The sensitivity of Toxo-ISAGA IgM® (adults 98.7%, neonates 63.1%) was similar to that of Platelia Toxo IgM® (adults 94.4%, neonates 64.6%), and significantly higher than Liaison Toxo IgM® (adults 90.6%), Architect/Alinity Toxo IgM® (adults 95.7%, neonates 48.6%), and Vidas Toxo IgM® (adults 81.8%, neonates 17.5%). However, the specificities varied between 24.4% (Platelia Toxo IgM®) and 95.2% (Liaison Toxo IgM®) in adults and were >95% for all tests in neonates. An analysis of the kappa coefficients showed better agreement between ISAGA IgM® and the other tests in children (0.75-0.83%) than in adults (0.11-0.53%). We conclude that, in the absence of Toxo-ISAGA IgM®, the association of a very sensitive technique (Platelia Toxo IgM® or Architect/Alinity Toxo IgM®) and a very specific technique (Vidas Toxo IgM® or Liaison Toxo IgM®) is recommended for IgM detection in adult sera. For neonates, Platelia Toxo IgM® appeared to be the best alternative to replace Toxo-ISAGA IgM®.

ISAGA IgM 和 ELISA 检测法在诊断母体和先天性弓形虫感染方面的性能比较:哪种技术可以取代 ISAGA IgM?
用于检测抗弓形虫免疫球蛋白 M 的 ISAGA 免疫捕获试验是一种手动技术,以其出色的灵敏度和特异性而著称。这项回顾性多中心研究旨在比较 ISAGA 和其他 IgM 检测技术在 ISAGA 停产前的性能和一致性。研究使用了 1341 份成人血清样本(弓形虫 IgM 阳性、IgG 阴性)和 1206 份新生儿血清样本(母亲血清转换),对不同检测方法的分析性能进行了评估。对 13,506 份成人血清样本和 5,795 份儿童血清样本进行了检测结果一致性评估。Toxo-ISAGA IgM® 的灵敏度(成人 98.7%,新生儿 63.1%)与 Platelia Toxo IgM® 的灵敏度(成人 94.4%,新生儿 64.6%)相似,明显高于 Liaison Toxo IgM®(成人 90.6%)、Architect/Alinity Toxo IgM®(成人 95.7%,新生儿 48.6%)和 Vidas Toxo IgM®(成人 81.8%,新生儿 17.5%)。然而,成人的特异性在24.4%(Platelia Toxo IgM®)和95.2%(Liaison Toxo IgM®)之间变化,而新生儿所有检测项目的特异性均大于95%。卡帕系数分析表明,ISAGA IgM® 和其他检测方法在儿童中的一致性(0.75-0.83%)优于成人(0.11-0.53%)。我们的结论是,在没有毒素-ISAGA IgM® 的情况下,建议将灵敏度很高的技术(Platelia Toxo IgM® 或 Architect/Alinity Toxo IgM®)和特异性很强的技术(Vidas Toxo IgM® 或 Liaison Toxo IgM®)结合起来,用于成人血清中 IgM 的检测。对于新生儿,Platelia Toxo IgM® 似乎是替代 Toxo-ISAGA IgM® 的最佳选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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