Wallon Martine, Fricker-Hidalgo Hélène, Chapey Emmanuelle, Bailet Claire, Dard Céline, Brenier-Pinchart Marie-Pierre, Pelloux Hervé
Service de Parasitologie et de Mycologie Médicale, Hôpital de la Croix Rousse, CHU de Lyon, Lyon, France.
Faculté de Médecine Lyon-Sud, Waking Team, Centre de Recherche en Neurosciences de Lyon, INSERM U1028-CNRS UMR 5292, Université Claude Bernard Lyon 1, Lyon, France.
Clin Chem Lab Med. 2020 Oct 25;58(11):1959-1964. doi: 10.1515/cclm-2019-1199.
Background Testing for anti-Toxoplasma immunoglobulin (Ig)M is of main importance in the context of pregnancy to promptly alert to an acute maternal infection prior to the detection of IgG and to identify infected newborns. Their absence helps exclude a recent maternal infection in the presence of IgG. Methods The performance of a Toxo IgM immunocapture prototype assay (bioMérieux, France) was compared with that of the VIDAS® Toxo IgM and the ARCHITECT® Toxo IgM (Abbott, Germany) assays at Grenoble and Lyon (France). A total of 1446 sera were sampled from (i) 1054 pregnant women found by routine workup to have no infection (n = 843), an acute infection (<4 months) (n = 28) or a chronic infection (>4 months) with residual (n = 120) or no IgM (n = 62); (ii) 50 three-serum panels sampled immediately after a maternal seroconversion; (iii) 242 samples taken in 41 children with a congenital toxoplasmosis (n = 122) and in 40 uninfected children (n = 120). Results In pregnant women, the overall agreement with the VIDAS® assay was 99.23% (CI: 99.16-99.27) and that with the ARCHITECT® assay was 99.14% (CI: 99.07-99.17). Sensitivity of the Toxo IgM prototype assay was 100% (CI: 87.66-100.00) and specificity was 99.64% (98.96-99.93). In acute maternal infections, IgM assays were detected as early with the prototype as with the other two. In the congenitally infected children, IgM were detected on their first sample in 25/40 with the prototype vs. 23/40 with the VIDAS® test. No uninfected child had positive IgM. Conclusion The prototype performed comparably to the ARCHITECT® and VIDAS® Toxo IgM assays for the diagnosis of maternal and congenital toxoplasmosis.
在孕期检测抗弓形虫免疫球蛋白（Ig）M至关重要，以便在检测到IgG之前及时提醒存在急性母体感染，并识别受感染的新生儿。在存在IgG的情况下，IgM阴性有助于排除近期的母体感染。方法：在法国格勒诺布尔和里昂，将弓形虫IgM免疫捕获原型检测法（法国生物梅里埃公司）的性能与VIDAS®弓形虫IgM检测法和ARCHITECT®弓形虫IgM检测法（德国雅培公司）进行比较。共采集了1446份血清，分别来自：（i）1054名经常规检查未发现感染的孕妇（n = 843）、急性感染（<4个月）的孕妇（n = 28）或慢性感染（>4个月）且有残留IgM（n = 120）或无IgM（n = 62）的孕妇；（ii）50个在母体血清转化后立即采集的三联血清样本组；（iii）从41名先天性弓形虫病患儿（n = 122）和40名未感染儿童（n = 120）中采集的242份样本。结果：在孕妇中，与VIDAS®检测法的总体一致性为99.23%（CI：99.16 - 99.27），与ARCHITECT®检测法的总体一致性为99.14%（CI：99.07 - 99.17）。弓形虫IgM原型检测法的灵敏度为100%（CI：87.66 - 100.00），特异性为99.64%（98.96 - 99.93）。在急性母体感染中，原型检测法与其他两种检测法一样能早期检测到IgM。在先天性感染儿童中，原型检测法在其首个样本中检测到IgM的比例为25/40，而VIDAS®检测法为23/40。没有未感染儿童的IgM呈阳性。结论：该原型检测法在诊断母体和先天性弓形虫病方面的表现与ARCHITECT®和VIDAS®弓形虫IgM检测法相当。
