Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests

Different agencies have emphasized the need to evaluate current serological methods for screening patients with suspected urogenital schistosomiasis. However, there is still a lack of evidence regarding the most appropriate methods for this purpose. Here we assessed the diagnostic efficacy of a newl...

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Main Authors: María Pilar Luzón-García, Laura Navarro, Esther Rodríguez, Manuel Jesús Soriano-Pérez, José Vázquez-Villegas, María Isabel Cabeza-Barrera, Alex Loukas, Nerea Castillo-Fernández, María Jesús Perteguer, Javier Sotillo, Joaquín Salas-Coronas
Format: Article
Language:English
Published: Cambridge University Press
Series:Parasitology
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Online Access:https://www.cambridge.org/core/product/identifier/S0031182024001574/type/journal_article
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author María Pilar Luzón-García
Laura Navarro
Esther Rodríguez
Manuel Jesús Soriano-Pérez
José Vázquez-Villegas
María Isabel Cabeza-Barrera
Alex Loukas
Nerea Castillo-Fernández
María Jesús Perteguer
Javier Sotillo
Joaquín Salas-Coronas
author_facet María Pilar Luzón-García
Laura Navarro
Esther Rodríguez
Manuel Jesús Soriano-Pérez
José Vázquez-Villegas
María Isabel Cabeza-Barrera
Alex Loukas
Nerea Castillo-Fernández
María Jesús Perteguer
Javier Sotillo
Joaquín Salas-Coronas
author_sort María Pilar Luzón-García
collection DOAJ
description Different agencies have emphasized the need to evaluate current serological methods for screening patients with suspected urogenital schistosomiasis. However, there is still a lack of evidence regarding the most appropriate methods for this purpose. Here we assessed the diagnostic efficacy of a newly developed serological technique that utilizes the recombinant protein Sh-TSP-2, applied to the urine and serum of migrants suspected of having urogenital schistosomiasis. The sensitivity, specificity, positive and negative predictive values of an in-house enzyme-linked immunosorbent assay (ELISA) using the recombinant protein Sh-TSP-2 were analysed and compared with other commercial serological methods. Due to the limitations of microscopy as a perfect reference method, a latent class analysis (LCA) and composite reference standard (CRS) approach was used to determine the sensitivity and specificity of each test. According to the LCA model, the commercial tests NovaLisa® and immunochromatography test (ICT) immunoglobulin G–immunoglobulin M (IgG–IgM) presented the highest sensitivity (100%), whereas the Sh-TSP-2 serum ELISA test had 79.2%. The Sh-TSP-2 urine and serum ELISA tests had the highest specificities among the serological methods (87.5 and 75%, respectively). CRS modelling showed that the ICT IgG–IgM, NovaLisa® and Sh-TSP-2 serum tests led in sensitivity at 97.1, 88.6 and 71.4%, respectively, with all tests except that the ICT IgG–IgM test having a specificity >90%. Sh-TSP-2 has been validated as a screening tool for patients suspected of having urogenital schistosomiasis. Although commercial serological tests have shown higher sensitivities, Sh-TSP-2 could be valuable for confirming results from tests with lower specificity. Nevertheless, further studies with larger patient cohorts are necessary to fully verify its potential.
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spelling doaj-art-2dd49505a534442f9d68ffd679af94d92025-01-22T08:48:25ZengCambridge University PressParasitology0031-18201469-816111010.1017/S0031182024001574Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available testsMaría Pilar Luzón-García0Laura Navarro1Esther Rodríguez2Manuel Jesús Soriano-Pérez3José Vázquez-Villegas4María Isabel Cabeza-Barrera5Alex Loukas6Nerea Castillo-Fernández7María Jesús Perteguer8Javier Sotillo9https://orcid.org/0000-0002-1443-7233Joaquín Salas-Coronas10https://orcid.org/0000-0002-4302-7022Tropical Medicine Unit, Hospital Universitario Poniente, Ctra. de Almerimar 31, 04700 El Ejido, Spain CIBERINFEC, ISCIII, Instituto de Salud Carlos III, Madrid, SpainParasitology Reference and Research Laboratory, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Madrid, SpainParasitology Reference and Research Laboratory, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Madrid, SpainTropical Medicine Unit, Hospital Universitario Poniente, Ctra. de Almerimar 31, 04700 El Ejido, SpainTropical Medicine Unit, Distrito Poniente de Almería, Almería, SpainTropical Medicine Unit, Hospital Universitario Poniente, Ctra. de Almerimar 31, 04700 El Ejido, SpainAustralian Institute of Tropical Health and Medicine, James Cook University, Cairns, AustraliaTropical Medicine Unit, Hospital Universitario Poniente, Ctra. de Almerimar 31, 04700 El Ejido, SpainCIBERINFEC, ISCIII, Instituto de Salud Carlos III, Madrid, Spain Parasitology Reference and Research Laboratory, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Madrid, SpainParasitology Reference and Research Laboratory, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Madrid, SpainTropical Medicine Unit, Hospital Universitario Poniente, Ctra. de Almerimar 31, 04700 El Ejido, Spain CIBERINFEC, ISCIII, Instituto de Salud Carlos III, Madrid, Spain Department of Nursing, Physiotherapy and Medicine, Faculty of Health Sciences, University of Almería, 04120 La Cañada, SpainDifferent agencies have emphasized the need to evaluate current serological methods for screening patients with suspected urogenital schistosomiasis. However, there is still a lack of evidence regarding the most appropriate methods for this purpose. Here we assessed the diagnostic efficacy of a newly developed serological technique that utilizes the recombinant protein Sh-TSP-2, applied to the urine and serum of migrants suspected of having urogenital schistosomiasis. The sensitivity, specificity, positive and negative predictive values of an in-house enzyme-linked immunosorbent assay (ELISA) using the recombinant protein Sh-TSP-2 were analysed and compared with other commercial serological methods. Due to the limitations of microscopy as a perfect reference method, a latent class analysis (LCA) and composite reference standard (CRS) approach was used to determine the sensitivity and specificity of each test. According to the LCA model, the commercial tests NovaLisa® and immunochromatography test (ICT) immunoglobulin G–immunoglobulin M (IgG–IgM) presented the highest sensitivity (100%), whereas the Sh-TSP-2 serum ELISA test had 79.2%. The Sh-TSP-2 urine and serum ELISA tests had the highest specificities among the serological methods (87.5 and 75%, respectively). CRS modelling showed that the ICT IgG–IgM, NovaLisa® and Sh-TSP-2 serum tests led in sensitivity at 97.1, 88.6 and 71.4%, respectively, with all tests except that the ICT IgG–IgM test having a specificity >90%. Sh-TSP-2 has been validated as a screening tool for patients suspected of having urogenital schistosomiasis. Although commercial serological tests have shown higher sensitivities, Sh-TSP-2 could be valuable for confirming results from tests with lower specificity. Nevertheless, further studies with larger patient cohorts are necessary to fully verify its potential.https://www.cambridge.org/core/product/identifier/S0031182024001574/type/journal_articlediagnosticsmigrantsSchistosoma haematobiumtravellersurogenital schistosomiasis
spellingShingle María Pilar Luzón-García
Laura Navarro
Esther Rodríguez
Manuel Jesús Soriano-Pérez
José Vázquez-Villegas
María Isabel Cabeza-Barrera
Alex Loukas
Nerea Castillo-Fernández
María Jesús Perteguer
Javier Sotillo
Joaquín Salas-Coronas
Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests
Parasitology
diagnostics
migrants
Schistosoma haematobium
travellers
urogenital schistosomiasis
title Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests
title_full Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests
title_fullStr Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests
title_full_unstemmed Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests
title_short Evaluation of the recombinant protein Sh-TSP-2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests
title_sort evaluation of the recombinant protein sh tsp 2 for the serological diagnosis of imported urogenital schistosomiasis and comparison with commercially available tests
topic diagnostics
migrants
Schistosoma haematobium
travellers
urogenital schistosomiasis
url https://www.cambridge.org/core/product/identifier/S0031182024001574/type/journal_article
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