Anderson Neil W, Klein Diane M, Dornink Sarina M, Jespersen Deborah J, Kubofcik Joseph, Nutman Thomas B, Merrigan Stephen D, Couturier Marc Roger, Theel Elitza S
Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Clin Vaccine Immunol. 2014 May;21(5):732-6. doi: 10.1128/CVI.00041-14. Epub 2014 Mar 19.
Due to the limited sensitivities of stool-based microscopy and/or culture techniques for Strongyloides stercoralis, the detection of antibodies to this intestinal nematode is relied upon as a surrogate for determining exposure status or making a diagnosis of S. stercoralis infection. Here, we evaluated three immunoassays, including the recently released InBios Strongy Detect IgG enzyme-linked immunosorbent assay (ELISA) (InBios International, Inc., Seattle, WA), the SciMedx Strongyloides serology microwell ELISA (SciMedx Corporation, Denville, NJ), and the luciferase immunoprecipitation system (LIPS) assay performed at the National Institutes of Health (NIH), for their detection of IgG antibodies to S. stercoralis. A total of 101 retrospective serum samples, previously submitted for routine S. stercoralis antibody detection using the SciMedx assay, were also evaluated by the InBios and LIPS assays. The qualitative results from each assay were compared using a Venn diagram analysis, to the consensus result among the three assays, and each ELISA was also evaluated using the LIPS assay as the reference standard. By Venn diagram analysis, 65% (66/101) of the samples demonstrated perfect agreement by all three assays. Also, the numbers of samples considered positive or negative by a single method were similar. Compared to the consensus result, the overall percent agreement of the InBios, SciMedx, and LIPS assays were comparable at 87.1%, 84.2%, and 89.1%, respectively. Finally, the two ELISAs performed analogously but demonstrated only moderate agreement (kappa coefficient for the two assays, 0.53) with the LIPS assay. Collectively, while the two commercially available ELISAs perform equivalently, neither should be used independently of clinical evaluation to diagnose strongyloidiasis.
由于基于粪便的显微镜检查和/或粪类圆线虫培养技术的敏感性有限,因此依靠检测针对这种肠道线虫的抗体来替代确定暴露状态或诊断粪类圆线虫感染。在此,我们评估了三种免疫测定法,包括最近发布的InBios Strongy Detect IgG酶联免疫吸附测定(ELISA)(InBios International公司,西雅图,华盛顿州)、SciMedx粪类圆线虫血清学微孔ELISA(SciMedx公司,丹维尔,新泽西州)以及在美国国立卫生研究院(NIH)进行的荧光素酶免疫沉淀系统(LIPS)测定,以检测它们对粪类圆线虫IgG抗体的检测能力。总共101份回顾性血清样本,之前使用SciMedx测定法提交用于常规粪类圆线虫抗体检测,也通过InBios和LIPS测定法进行了评估。使用维恩图分析将每种测定法的定性结果与三种测定法之间的一致结果进行比较,并且还以LIPS测定法作为参考标准对每种ELISA进行了评估。通过维恩图分析,65%(66/101)的样本在所有三种测定法中显示出完全一致。此外,通过单一方法被视为阳性或阴性的样本数量相似。与一致结果相比,InBios、SciMedx和LIPS测定法的总体一致百分比分别为87.1%、84.2%和89.1%,具有可比性。最后,两种ELISA表现类似,但与LIPS测定法仅显示出中等一致性(两种测定法的kappa系数为0.53)。总体而言,虽然两种市售ELISA表现相当,但都不应独立于临床评估用于诊断类圆线虫病。