ArticleParasites & vectors2026
Evaluation of the diagnostic performance of a commercial ELISA based on two recombinant antigens for the diagnosis of Strongyloides stercoralis infection.
Article in Parasites & vectors, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe WHO guideline for the public health control of Strongyloides stercoralis recommends the deployment of Baermann or agar plate culture to estimate the infection prevalence. However, the guideline includes the possible use of antibody-based assays, which might be preferred in some countries. An ELISA based on two recombinant antigens (Strongy Detect ELISA by InBios), performed on dried blood spots (DBS), demonstrated suitable for use in a diagnostic study carried out in remote areas of Ecuador ("ESTRELLA"). A new version of that assay, which aimed at improving specificity according to the indications reported in the target product profile (TPP) for the diagnostics for S. stercoralis, was recently made available in the market. Aim of this study was to compare the performance of the two versions of that ELISA.
methodsThe DBS collected in the context of the study in Ecuador were tested with the new ELISA. Sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively) were calculated with Bayesian Latent Class Analysis (BLCA). Bayesian estimates were reported as posterior medians with corresponding 95% credible intervals (CrI). Test agreement was calculated with both BLCA and Cohen's kappa.
resultsSensitivity was 66.7% (95% CrI 52.8-80.6) for the new assay, versus 78.8% (95% CrI 66.7-89.2) of the old version (posterior probability that the new test had higher sensitivity = 0.1). Specificity was markedly higher for the new version compared to the previous assay: 98.8% (95% CrI 97.9-99.4) versus 90.1% (95% CrI 87.6-92.4), respectively (posterior probability that the new test had higher specificity = 1). PPV for the new ELISA proved good at all prevalence values considered, going from 80.1% (CrI 67.0-89.4%) when prevalence was 7% to 95.8% (92.5%, 97.9%) with 30% prevalence. The agreement was fair (Cohen's kappa 0.38; 95% CI 0.26-0.49).
conclusionsThe new version of the Strongy Detect ELISA demonstrated improved specificity with a moderate reduction in sensitivity compared to the previous version, meeting the TPP requirements in terms of diagnostic performance. Adherence with the other TPP requirements was out of the scope of this study, and should be assessed elsewhere.
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