Evaluation of Two HIV Rapid Diagnostic Tests in a Context of Strains' Genetic Diversity in Mali
The rapid diagnostic tests used in most resource-limited countries offer little specificity in the differentiation of HIV-1, HIV-2, and HIV-1 + 2. World Health Organization (WHO) does periodically evaluate rapid tests in use in the South Countries. Despite the prequalification from WHO, it is necess...
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creator | Togo, Josue Maiga, Almoustapha Issiaka Sylla, Mariam Kone, Bourahima Dolo, Oumar Traore, Fatoumata Tata Sangare, Samba Adama Maiga, Mamoudou Diallo, Souleymane Murphy, Robert Calvez, Vincent Marcelin, Anne-Genevieve |
description | The rapid diagnostic tests used in most resource-limited countries offer little specificity in the differentiation of HIV-1, HIV-2, and HIV-1 + 2. World Health Organization (WHO) does periodically evaluate rapid tests in use in the South Countries. Despite the prequalification from WHO, it is necessary at local level to conduct comparative studies between the available tests. To do this in Mali, we conducted a cross-sectional study at the University Teaching Hospital Gabriel Touré and the Research and Training Center (SEREFO) of Bamako on 172 samples from retrospective and prospective studies. The goal of this project was to compare the following rapid tests: "HIV TRI-DOT" and OnSite HIV1/2 Ab Plus Combo Rapid Test for screening HIV-1 and HIV-2 to "ImmunoComb II BiSpot" (gold standard). The sensibility and specificity of "HIV TRI-DOT" for HIV-1 detection were 100% each [95% confidence interval (CI): 87.13-100 and 95.31-100]. Its performance for HIV-2 detection was 95.24% (95% CI: 84.21-98.68) (sensibility) and 100% (95% CI: 72.25-100) (specificity). The positive and negative predictive values were, respectively, 100% (95% CI: 91.24-100) and 83.33% (95% CI: 55.20-95.30). The sensibility and specificity of OnSite HIV1/2 Ab Plus Combo Rapid Test assay performance were 100% (95% CI: 87.13-100 and 95.31-100). Overall, OnSite HIV ½ Ab Combo Rapid Test proved to be a good test for warm countries and does not require refrigeration in these settings. Blood and its products can be used to perform the test, unlike "ImmunoComb II BiSpot" and "HIV TRI-DOT," which must be kept cold and cannot be done with whole blood. |
doi_str_mv | 10.1089/aid.2017.0296 |
format | Article |
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World Health Organization (WHO) does periodically evaluate rapid tests in use in the South Countries. Despite the prequalification from WHO, it is necessary at local level to conduct comparative studies between the available tests. To do this in Mali, we conducted a cross-sectional study at the University Teaching Hospital Gabriel Touré and the Research and Training Center (SEREFO) of Bamako on 172 samples from retrospective and prospective studies. The goal of this project was to compare the following rapid tests: "HIV TRI-DOT" and OnSite HIV1/2 Ab Plus Combo Rapid Test for screening HIV-1 and HIV-2 to "ImmunoComb II BiSpot" (gold standard). The sensibility and specificity of "HIV TRI-DOT" for HIV-1 detection were 100% each [95% confidence interval (CI): 87.13-100 and 95.31-100]. Its performance for HIV-2 detection was 95.24% (95% CI: 84.21-98.68) (sensibility) and 100% (95% CI: 72.25-100) (specificity). The positive and negative predictive values were, respectively, 100% (95% CI: 91.24-100) and 83.33% (95% CI: 55.20-95.30). The sensibility and specificity of OnSite HIV1/2 Ab Plus Combo Rapid Test assay performance were 100% (95% CI: 87.13-100 and 95.31-100). Overall, OnSite HIV ½ Ab Combo Rapid Test proved to be a good test for warm countries and does not require refrigeration in these settings. Blood and its products can be used to perform the test, unlike "ImmunoComb II BiSpot" and "HIV TRI-DOT," which must be kept cold and cannot be done with whole blood.</description><identifier>ISSN: 0889-2229</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/aid.2017.0296</identifier><identifier>PMID: 30560678</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Adolescent ; Adult ; AIDS/HIV ; Blood ; Child ; Child, Preschool ; Comparative studies ; Confidence intervals ; Cross-Sectional Studies ; Diagnostic systems ; Diagnostic tests ; Epidemiology ; Female ; Genetic diversity ; Genetic Variation ; HIV ; HIV Antibodies - blood ; HIV Infections - diagnosis ; HIV Infections - virology ; HIV-1 - genetics ; HIV-1 - immunology ; HIV-2 - genetics ; HIV-2 - immunology ; Human immunodeficiency virus ; Humans ; Male ; Mali ; Middle Aged ; Onsite ; Predictive Value of Tests ; Reagent Kits, Diagnostic - standards ; Refrigeration ; Retrospective Studies ; Sensitivity and Specificity ; Serologic Tests - standards ; Young Adult</subject><ispartof>AIDS research and human retroviruses, 2019-02, Vol.35 (2), p.145-149</ispartof><rights>Copyright Mary Ann Liebert, Inc. Feb 2019</rights><rights>Copyright 2019, Mary Ann Liebert, Inc., publishers 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-9fca9241bc0408809bac9afd80f6b10ee836b6e88302f1ffaf995deacefb5ac73</citedby><cites>FETCH-LOGICAL-c415t-9fca9241bc0408809bac9afd80f6b10ee836b6e88302f1ffaf995deacefb5ac73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,782,786,887,27931,27932</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30560678$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Togo, Josue</creatorcontrib><creatorcontrib>Maiga, Almoustapha Issiaka</creatorcontrib><creatorcontrib>Sylla, Mariam</creatorcontrib><creatorcontrib>Kone, Bourahima</creatorcontrib><creatorcontrib>Dolo, Oumar</creatorcontrib><creatorcontrib>Traore, Fatoumata Tata</creatorcontrib><creatorcontrib>Sangare, Samba Adama</creatorcontrib><creatorcontrib>Maiga, Mamoudou</creatorcontrib><creatorcontrib>Diallo, Souleymane</creatorcontrib><creatorcontrib>Murphy, Robert</creatorcontrib><creatorcontrib>Calvez, Vincent</creatorcontrib><creatorcontrib>Marcelin, Anne-Genevieve</creatorcontrib><title>Evaluation of Two HIV Rapid Diagnostic Tests in a Context of Strains' Genetic Diversity in Mali</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>The rapid diagnostic tests used in most resource-limited countries offer little specificity in the differentiation of HIV-1, HIV-2, and HIV-1 + 2. World Health Organization (WHO) does periodically evaluate rapid tests in use in the South Countries. Despite the prequalification from WHO, it is necessary at local level to conduct comparative studies between the available tests. To do this in Mali, we conducted a cross-sectional study at the University Teaching Hospital Gabriel Touré and the Research and Training Center (SEREFO) of Bamako on 172 samples from retrospective and prospective studies. The goal of this project was to compare the following rapid tests: "HIV TRI-DOT" and OnSite HIV1/2 Ab Plus Combo Rapid Test for screening HIV-1 and HIV-2 to "ImmunoComb II BiSpot" (gold standard). The sensibility and specificity of "HIV TRI-DOT" for HIV-1 detection were 100% each [95% confidence interval (CI): 87.13-100 and 95.31-100]. Its performance for HIV-2 detection was 95.24% (95% CI: 84.21-98.68) (sensibility) and 100% (95% CI: 72.25-100) (specificity). The positive and negative predictive values were, respectively, 100% (95% CI: 91.24-100) and 83.33% (95% CI: 55.20-95.30). The sensibility and specificity of OnSite HIV1/2 Ab Plus Combo Rapid Test assay performance were 100% (95% CI: 87.13-100 and 95.31-100). Overall, OnSite HIV ½ Ab Combo Rapid Test proved to be a good test for warm countries and does not require refrigeration in these settings. Blood and its products can be used to perform the test, unlike "ImmunoComb II BiSpot" and "HIV TRI-DOT," which must be kept cold and cannot be done with whole blood.</description><subject>Adolescent</subject><subject>Adult</subject><subject>AIDS/HIV</subject><subject>Blood</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Comparative studies</subject><subject>Confidence intervals</subject><subject>Cross-Sectional Studies</subject><subject>Diagnostic systems</subject><subject>Diagnostic tests</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Genetic diversity</subject><subject>Genetic Variation</subject><subject>HIV</subject><subject>HIV Antibodies - blood</subject><subject>HIV Infections - diagnosis</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - immunology</subject><subject>HIV-2 - genetics</subject><subject>HIV-2 - immunology</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Male</subject><subject>Mali</subject><subject>Middle Aged</subject><subject>Onsite</subject><subject>Predictive Value of Tests</subject><subject>Reagent Kits, Diagnostic - standards</subject><subject>Refrigeration</subject><subject>Retrospective Studies</subject><subject>Sensitivity and Specificity</subject><subject>Serologic Tests - standards</subject><subject>Young Adult</subject><issn>0889-2229</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkUFP3DAQhS3UCra0R67IUg_0kmVsJ1n7UgktFJBASGXp1Zo4NjXK2kucbMu_bywoKj3NYT49vaePkAMGcwZSHaNv5xzYYg5c1TtkxpRghSyhekdmIKUqOOdqj3xI6QEAFOfVLtkTUNVQL-SM6LMtdiMOPgYaHV39ivTi8gf9jhvf0lOP9yGmwRu6smlI1AeKdBnDYH8PGb8devQhHdFzG2zGTv3W9skPTxm9xs5_JO8ddsl-ern75O7b2Wp5UVzdnF8uT64KU7JqKJQzqHjJGgPl1BpUg0ahayW4umFgrRR1U1spBXDHnEOnVNVaNNY1FZqF2Cdfn3M3Y7O2rbFhqtbpTe_X2D_piF6__QT_U9_Hra5LzgFywJeXgD4-jtNavfbJ2K7DYOOYNGeV5EIpmdHP_6EPcezDNE9zLkpgQvFMFc-U6WNKvXWvZRjorE5P6nRWp7O6iT_8d8Er_deV-AOZHJVm</recordid><startdate>20190201</startdate><enddate>20190201</enddate><creator>Togo, Josue</creator><creator>Maiga, Almoustapha Issiaka</creator><creator>Sylla, Mariam</creator><creator>Kone, Bourahima</creator><creator>Dolo, Oumar</creator><creator>Traore, Fatoumata Tata</creator><creator>Sangare, Samba Adama</creator><creator>Maiga, Mamoudou</creator><creator>Diallo, Souleymane</creator><creator>Murphy, Robert</creator><creator>Calvez, Vincent</creator><creator>Marcelin, Anne-Genevieve</creator><general>Mary Ann Liebert, Inc</general><general>Mary Ann Liebert, Inc., publishers</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T5</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190201</creationdate><title>Evaluation of Two HIV Rapid Diagnostic Tests in a Context of Strains' Genetic Diversity in Mali</title><author>Togo, Josue ; 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World Health Organization (WHO) does periodically evaluate rapid tests in use in the South Countries. Despite the prequalification from WHO, it is necessary at local level to conduct comparative studies between the available tests. To do this in Mali, we conducted a cross-sectional study at the University Teaching Hospital Gabriel Touré and the Research and Training Center (SEREFO) of Bamako on 172 samples from retrospective and prospective studies. The goal of this project was to compare the following rapid tests: "HIV TRI-DOT" and OnSite HIV1/2 Ab Plus Combo Rapid Test for screening HIV-1 and HIV-2 to "ImmunoComb II BiSpot" (gold standard). The sensibility and specificity of "HIV TRI-DOT" for HIV-1 detection were 100% each [95% confidence interval (CI): 87.13-100 and 95.31-100]. Its performance for HIV-2 detection was 95.24% (95% CI: 84.21-98.68) (sensibility) and 100% (95% CI: 72.25-100) (specificity). The positive and negative predictive values were, respectively, 100% (95% CI: 91.24-100) and 83.33% (95% CI: 55.20-95.30). The sensibility and specificity of OnSite HIV1/2 Ab Plus Combo Rapid Test assay performance were 100% (95% CI: 87.13-100 and 95.31-100). Overall, OnSite HIV ½ Ab Combo Rapid Test proved to be a good test for warm countries and does not require refrigeration in these settings. Blood and its products can be used to perform the test, unlike "ImmunoComb II BiSpot" and "HIV TRI-DOT," which must be kept cold and cannot be done with whole blood.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>30560678</pmid><doi>10.1089/aid.2017.0296</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adolescent Adult AIDS/HIV Blood Child Child, Preschool Comparative studies Confidence intervals Cross-Sectional Studies Diagnostic systems Diagnostic tests Epidemiology Female Genetic diversity Genetic Variation HIV HIV Antibodies - blood HIV Infections - diagnosis HIV Infections - virology HIV-1 - genetics HIV-1 - immunology HIV-2 - genetics HIV-2 - immunology Human immunodeficiency virus Humans Male Mali Middle Aged Onsite Predictive Value of Tests Reagent Kits, Diagnostic - standards Refrigeration Retrospective Studies Sensitivity and Specificity Serologic Tests - standards Young Adult |
title | Evaluation of Two HIV Rapid Diagnostic Tests in a Context of Strains' Genetic Diversity in Mali |
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