Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations
Background: We aimed to evaluate the performance of a novel multiplex serological assay, able to simultaneously detect IgG of six infections, as a screening tool for imported diseases in migrants. Methods: Six panels of 40 (n = 240) anonymized serum samples with confirmed infections were used as pos...
Main Authors: | , , , , , , , , , , , , , , , , , , |
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Format: | Article |
Language: | English |
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Elsevier
2024-01-01
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Series: | Travel Medicine and Infectious Disease |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S1477893923001412 |
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author | Ruth Aguilar Angeline Cruz Alfons Jiménez Alex Almuedo Carme Roca Saumell Marina Gigante Lopez Oriol Gasch Gemma Falcó Ana Jiménez-Lozano Angela Martínez-Perez Consol Sanchez-Collado Andrea Tedesco Manuel Carlos López María Jesús Pinazo Thais Leonel Zeno Bisoffi Anna Färnert Carlota Dobaño Ana Requena-Méndez |
author_facet | Ruth Aguilar Angeline Cruz Alfons Jiménez Alex Almuedo Carme Roca Saumell Marina Gigante Lopez Oriol Gasch Gemma Falcó Ana Jiménez-Lozano Angela Martínez-Perez Consol Sanchez-Collado Andrea Tedesco Manuel Carlos López María Jesús Pinazo Thais Leonel Zeno Bisoffi Anna Färnert Carlota Dobaño Ana Requena-Méndez |
author_sort | Ruth Aguilar |
collection | DOAJ |
description | Background: We aimed to evaluate the performance of a novel multiplex serological assay, able to simultaneously detect IgG of six infections, as a screening tool for imported diseases in migrants. Methods: Six panels of 40 (n = 240) anonymized serum samples with confirmed infections were used as positive controls to assess the multiplex assay's sensitivity. One panel of 40 sera from non-infected subjects was used to estimate the seropositivity cutoffs, and 32 non-infected sera were used as negative controls to estimate each serology's sensitivity and specificity. The multi-infection screening test was validated in a prospective cohort of 48 migrants from endemic areas.The sensitivity of the Luminex assay was calculated as the proportion of positive results over all positive samples identified by reference tests. The specificity was calculated using 32 negative samples. Uncertainty was quantified with 95 % confidence intervals using receiver operating characteristic analyses. Results: The sensitivity/specificity were 100 %/100 % for HIV (gp41 antigen), 97.5 %/100 % for Hepatitis B virus (HBV-core antigen), 100 %/100 % for Hepatitis C virus (HCV-core antigen), 92.5 %/90.6 % for strongyloidiasis [31-kDa recombinant antigen (NIE)], 97.5 %/100 % for schistosomiasis (combined serpin Schistosoma mansoni and S.haematobium antigens) and 95 %/90.6 % for Chagas disease [combined Trypanosoma cruzi kinetoplastid membrane protein-11 (KMP11) and paraflagellar rod proteins 2 (PFR2) antigens].In the migrant cohort, antibody response to the combination of the T.cruzi antigens correctly identified 100 % individuals, whereas HBV-core antigen correctly identified 91.7 % and Strongyloides-NIE antigen 86.4 %. Conclusions: We developed a new, robust and accurate 8-plex Luminex assay that could facilitate the implementation of screening programmes targeting migrant populations. |
first_indexed | 2024-03-08T13:02:02Z |
format | Article |
id | doaj.art-2ffdd2faeff744d1b86a54c5229f9c97 |
institution | Directory Open Access Journal |
issn | 1873-0442 |
language | English |
last_indexed | 2024-03-08T13:02:02Z |
publishDate | 2024-01-01 |
publisher | Elsevier |
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series | Travel Medicine and Infectious Disease |
spelling | doaj.art-2ffdd2faeff744d1b86a54c5229f9c972024-01-19T04:54:06ZengElsevierTravel Medicine and Infectious Disease1873-04422024-01-0157102681Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populationsRuth Aguilar0Angeline Cruz1Alfons Jiménez2Alex Almuedo3Carme Roca Saumell4Marina Gigante Lopez5Oriol Gasch6Gemma Falcó7Ana Jiménez-Lozano8Angela Martínez-Perez9Consol Sanchez-Collado10Andrea Tedesco11Manuel Carlos López12María Jesús Pinazo13Thais Leonel14Zeno Bisoffi15Anna Färnert16Carlota Dobaño17Ana Requena-Méndez18Barcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Carrer Roselló 132, 08036, Barcelona, SpainBarcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Carrer Roselló 132, 08036, Barcelona, SpainBarcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Carrer Roselló 132, 08036, Barcelona, Spain; Biomedical Research Networking Center for Epidemiology and Public Health (CIBERESP), Avenida Monforte de Lemos 3-5, 28029, Madrid, SpainBarcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Carrer Roselló 132, 08036, Barcelona, SpainCentre d'Atenció Primaria El Clot, Institut Català de la Salut (ICS), Carrer Concilio de Trento 25, 08018, Barcelona, Spain; Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB), Carrer Casanova, 143, 08036, Barcelona, SpainCentre d'Atenció Primaria Center Numància, Institut Català de la Salut (ICS), Carrer Numància 23, 08029, Barcelona, SpainInfectious Diseases Department, Hospital Universitari Parc Taulí. Institut d’Investigació i Innovació Parc Taulí. Universitat Autònoma de Barcelona, Parc Taulí, 1, 08208, Sabadell-Barcelona, SpainCentre d'Atenció Primaria Sant Miquel, Institut Català de la Salut (ICS), Carrer Francesc Macià i Llussà, 154, 08401, Granollers-Barcelona, SpainCentre d'Atenció Primaria Adrià 5A Marc Aureli, Institut Català de la Salut (ICS), Carrer Vallmajor, 34, 08021, Barcelona, SpainCentre d'Atenció Primaria Casanova. Consorci d'Atenció Primària de Salut de l'Eixample (CAPSBE) Casanova. Carrer Rosselló 161, 08036, Barcelona, SpainCentre d'Atenció Primaria Torelló, Institut Català de la Salut (ICS), Avenida Pompeu Fabra, 8, 08570, Torelló-Barcelona, SpainDepartment of Infectious Tropical diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Via Sempreboni 5, 37024, Negrar di Valpolicella, ItalySpanish National Research Council (IPBLN-CSIC), Avenida del Conocimiento 17, Parque Tecnológico de Ciencias de la Salud, 18016, Granada, SpainBarcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Carrer Roselló 132, 08036, Barcelona, Spain; Biomedical Research Networking Center (CIBER) of Infectious Diseases, Carlos III Health Institute (CIBERINFEC, ISCIII), Carrer Melchor Fernández Almagro, 3, 28029, Madrid, SpainLiver Unit, Hospital Clínic, University of Barcelona, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Biomedical Research Networking Center of Hepatic and Digestive Diseases (CIBEREHD), Carrer Villarroel, 170, 08036, Barcelona, SpainDepartment of Infectious Tropical diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Via Sempreboni 5, 37024, Negrar di Valpolicella, ItalyDepartment of Medicine Solna, Karolinska Institutet, Solnavägen 1, 17177, Solna-Stockholm, Sweden; Department of Infectious Diseases, Karolinska University Hospital, Solnavägen 1, 17177, Solna-Stockholm, SwedenBarcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Carrer Roselló 132, 08036, Barcelona, Spain; Biomedical Research Networking Center (CIBER) of Infectious Diseases, Carlos III Health Institute (CIBERINFEC, ISCIII), Carrer Melchor Fernández Almagro, 3, 28029, Madrid, SpainBarcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Carrer Roselló 132, 08036, Barcelona, Spain; Biomedical Research Networking Center (CIBER) of Infectious Diseases, Carlos III Health Institute (CIBERINFEC, ISCIII), Carrer Melchor Fernández Almagro, 3, 28029, Madrid, Spain; Department of Medicine Solna, Karolinska Institutet, Solnavägen 1, 17177, Solna-Stockholm, Sweden; Department of Infectious Diseases, Karolinska University Hospital, Solnavägen 1, 17177, Solna-Stockholm, Sweden; Corresponding author. Karolinska Institutet, Department of Medicine Solna, Sweden.Background: We aimed to evaluate the performance of a novel multiplex serological assay, able to simultaneously detect IgG of six infections, as a screening tool for imported diseases in migrants. Methods: Six panels of 40 (n = 240) anonymized serum samples with confirmed infections were used as positive controls to assess the multiplex assay's sensitivity. One panel of 40 sera from non-infected subjects was used to estimate the seropositivity cutoffs, and 32 non-infected sera were used as negative controls to estimate each serology's sensitivity and specificity. The multi-infection screening test was validated in a prospective cohort of 48 migrants from endemic areas.The sensitivity of the Luminex assay was calculated as the proportion of positive results over all positive samples identified by reference tests. The specificity was calculated using 32 negative samples. Uncertainty was quantified with 95 % confidence intervals using receiver operating characteristic analyses. Results: The sensitivity/specificity were 100 %/100 % for HIV (gp41 antigen), 97.5 %/100 % for Hepatitis B virus (HBV-core antigen), 100 %/100 % for Hepatitis C virus (HCV-core antigen), 92.5 %/90.6 % for strongyloidiasis [31-kDa recombinant antigen (NIE)], 97.5 %/100 % for schistosomiasis (combined serpin Schistosoma mansoni and S.haematobium antigens) and 95 %/90.6 % for Chagas disease [combined Trypanosoma cruzi kinetoplastid membrane protein-11 (KMP11) and paraflagellar rod proteins 2 (PFR2) antigens].In the migrant cohort, antibody response to the combination of the T.cruzi antigens correctly identified 100 % individuals, whereas HBV-core antigen correctly identified 91.7 % and Strongyloides-NIE antigen 86.4 %. Conclusions: We developed a new, robust and accurate 8-plex Luminex assay that could facilitate the implementation of screening programmes targeting migrant populations.http://www.sciencedirect.com/science/article/pii/S1477893923001412MigrantsScreeningLuminexIgGSensitivitySpecificity |
spellingShingle | Ruth Aguilar Angeline Cruz Alfons Jiménez Alex Almuedo Carme Roca Saumell Marina Gigante Lopez Oriol Gasch Gemma Falcó Ana Jiménez-Lozano Angela Martínez-Perez Consol Sanchez-Collado Andrea Tedesco Manuel Carlos López María Jesús Pinazo Thais Leonel Zeno Bisoffi Anna Färnert Carlota Dobaño Ana Requena-Méndez Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations Travel Medicine and Infectious Disease Migrants Screening Luminex IgG Sensitivity Specificity |
title | Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations |
title_full | Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations |
title_fullStr | Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations |
title_full_unstemmed | Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations |
title_short | Evaluation of the accuracy of a multi-infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations |
title_sort | evaluation of the accuracy of a multi infection screening test based on a multiplex immunoassay targeting imported diseases common in migrant populations |
topic | Migrants Screening Luminex IgG Sensitivity Specificity |
url | http://www.sciencedirect.com/science/article/pii/S1477893923001412 |
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