{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T04:50:06Z","timestamp":1791435006671,"version":"4.3.3"},"reference-count":25,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:00:00Z","timestamp":1791244800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Italian Ministry of Health","award":["L3P2"],"award-info":[{"award-number":["L3P2"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives:\u00a0Strongyloides stercoralis is a soil-transmitted helminth that can cause severe disease in immunocompromised individuals. In non-endemic clinical settings, recommended diagnostic strategies rely on serology alone or in combination with a sensitive fecal test, maximizing sensitivity to avoid missed infections. The S. stercoralis VirClia\u00ae IgG monotest (Vircell, Spain) is a novel automated chemiluminescent immunoassay (CLIA) that detects IgG antibodies against the recombinant NIE and SsIR antigens. This study evaluated its diagnostic accuracy (sensitivity and specificity) in a non-endemic clinical setting. Methods: In this monocentric retrospective study, 245 serum samples from the Tropica Biobank of a referral centre for parasitic diseases in Italy were analyzed. Samples originated from individuals from Africa (n = 85), America (n = 31), Asia (n = 53), and Europe (n = 76). Diagnostic accuracy was estimated using Bayesian latent class analysis based on a model including five routinely used diagnostic tests. Results: The S. stercoralis VirClia\u00ae IgG monotest showed a sensitivity of 95.0% (95% credible interval [CrI]: 90.1\u201398.2%) and a specificity of 90.8% (95% CrI: 85.1\u201396.0%) for the tested population. Conclusions: In immunocompetent individuals with a risk of previous exposure to S. stercoralis, the S. stercoralis VirClia\u00ae IgG monotest showed high diagnostic accuracy. Its high sensitivity supports current recommendations favouring highly sensitive serological assays for screening and diagnosis in non-endemic clinical settings.<\/jats:p>","DOI":"10.3390\/diagnostics16193227","type":"journal-article","created":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T10:46:29Z","timestamp":1791283589000},"page":"3227","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic Accuracy of a Novel Chemiluminescent Immunoassay for Strongyloides stercoralis in a Non-Endemic Clinical Setting"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0072-9649","authenticated-orcid":false,"given":"Sara","family":"Roose","sequence":"first","affiliation":[{"name":"Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-5676-5181","authenticated-orcid":false,"given":"Lorenza","family":"Sanfilippo","sequence":"additional","affiliation":[{"name":"Clinical Research Unit, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Tais","sequence":"additional","affiliation":[{"name":"Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Negrelli","sequence":"additional","affiliation":[{"name":"Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Rizzi","sequence":"additional","affiliation":[{"name":"Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Gambini","sequence":"additional","affiliation":[{"name":"Clinical Research Unit, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0478-3914","authenticated-orcid":false,"given":"Francesca","family":"Tamarozzi","sequence":"additional","affiliation":[{"name":"Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3933-3892","authenticated-orcid":false,"given":"Francesca","family":"Perandin","sequence":"additional","affiliation":[{"name":"Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0108-6822","authenticated-orcid":false,"given":"Dora","family":"Buonfrate","sequence":"additional","affiliation":[{"name":"Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,10,6]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Buonfrate, D., Bisanzio, D., Giorli, G., Odermatt, P., F\u00fcrst, T., Greenaway, C., French, M., Reithinger, R., Gobbi, F., and Montresor, A. 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