Short Communication: Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda
Point of care rapid recency testing for HIV-1 may be a cost-effective tool to identify recently infected individuals for incidence estimation, and focused HIV prevention through intensified contact tracing. We validated the Asante™ HIV-1 rapid recency assay for use in Uganda. Archived specimens (ser...
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| Veröffentlicht in: | AIDS research and human retroviruses 2021-12, Vol.37 (12), p.893-896 |
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| creator | Galiwango, Ronald Moses Ssuuna, Charles Kaleebu, Pontiano Kigozi, Godfrey Kagaayi, Joseph Nakigozi, Gertrude Reynolds, Steven James Lutalo, Tom Kankaka, Edward Nelson Wasswa, John Bosco Kalibbala, Sarah N Kigozi, Aminah N Watera, Christine Ejang, Julia Ndyanabo, Anthony Anok, Aggrey J Ssemwanga, Deogratius Kibengo, Freddie M Quinn, Thomas C Grabowski, Mary Chang, Larry W Wawer, Maria Gray, Ronald Laeyendecker, Oliver Serwadda, David |
| description | Point of care rapid recency testing for HIV-1 may be a cost-effective tool to identify recently infected individuals for incidence estimation, and focused HIV prevention through intensified contact tracing. We validated the Asante™ HIV-1 rapid recency
assay for use in Uganda. Archived specimens (serum/plasma), collected from longitudinally observed HIV-1 recently and long-term infected participants, were tested with the Asante HIV-1 rapid recency assay per manufacturer's instructions. Previously identified antiretroviral therapy (ART)-naive samples with known seroconversions within 6 months of follow-up were tested in independent laboratories: the Rakai Health Sciences Program (RHSP) and the Uganda Virus Research Institute HIV Reference Laboratory (UVRI-HRL). In addition, samples from participants who seroconverted within 6-18 months and samples from individuals with chronic HIV-1 infection of at least 18 months duration were classified into three categories: ART naive, ART exposed with suppressed viral loads, and ART exposed with detectable viremia. Of the 85 samples seroconverting in ≤6 months, 27 and 42 samples were identified as "recent" by the Asante HIV-1 rapid recency test at the RHSP laboratory and UVRI-HRL, corresponding to sensitivities of 32% and 49%, respectively. There was 72% agreement between the laboratories (Cohen's kappa = 0.481, 95% CI = 0.317-0.646,
|
| doi_str_mv | 10.1089/aid.2020.0279 |
| format | Article |
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< .0001). Specificity was 100% (200/200) among chronically infected ART-naive samples. The Asante HIV-1 rapid recency assay had low sensitivity for detection of recent HIV-1 infections in Uganda, with substantial interlaboratory variability due to differential interpretation of the test strip bands. Specificity was excellent. Assessment of assay performance in other settings is needed to guide decisions on test utility.</description><identifier>ISSN: 0889-2229</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/aid.2020.0279</identifier><identifier>PMID: 33499732</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Antiretroviral agents ; Antiretroviral therapy ; Assaying ; Chronic infection ; Contact tracing ; Epidemiology ; HIV ; HIV Infections - diagnosis ; HIV Infections - epidemiology ; HIV Seropositivity ; HIV-1 ; Human immunodeficiency virus ; Humans ; Laboratories ; Sensitivity ; Uganda - epidemiology ; Viral Load ; Viremia</subject><ispartof>AIDS research and human retroviruses, 2021-12, Vol.37 (12), p.893-896</ispartof><rights>Copyright Mary Ann Liebert, Inc. Dec 2021</rights><rights>Copyright 2021, Mary Ann Liebert, Inc., publishers 2021 Mary Ann Liebert, Inc., publishers</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3309-b126c214472ad4503f5f2d8866d0c4d96ea7740cf44317f56b0f84c3440c4b803</citedby><cites>FETCH-LOGICAL-c3309-b126c214472ad4503f5f2d8866d0c4d96ea7740cf44317f56b0f84c3440c4b803</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,886,27929,27930</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33499732$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Galiwango, Ronald Moses</creatorcontrib><creatorcontrib>Ssuuna, Charles</creatorcontrib><creatorcontrib>Kaleebu, Pontiano</creatorcontrib><creatorcontrib>Kigozi, Godfrey</creatorcontrib><creatorcontrib>Kagaayi, Joseph</creatorcontrib><creatorcontrib>Nakigozi, Gertrude</creatorcontrib><creatorcontrib>Reynolds, Steven James</creatorcontrib><creatorcontrib>Lutalo, Tom</creatorcontrib><creatorcontrib>Kankaka, Edward Nelson</creatorcontrib><creatorcontrib>Wasswa, John Bosco</creatorcontrib><creatorcontrib>Kalibbala, Sarah N</creatorcontrib><creatorcontrib>Kigozi, Aminah N</creatorcontrib><creatorcontrib>Watera, Christine</creatorcontrib><creatorcontrib>Ejang, Julia</creatorcontrib><creatorcontrib>Ndyanabo, Anthony</creatorcontrib><creatorcontrib>Anok, Aggrey J</creatorcontrib><creatorcontrib>Ssemwanga, Deogratius</creatorcontrib><creatorcontrib>Kibengo, Freddie M</creatorcontrib><creatorcontrib>Quinn, Thomas C</creatorcontrib><creatorcontrib>Grabowski, Mary</creatorcontrib><creatorcontrib>Chang, Larry W</creatorcontrib><creatorcontrib>Wawer, Maria</creatorcontrib><creatorcontrib>Gray, Ronald</creatorcontrib><creatorcontrib>Laeyendecker, Oliver</creatorcontrib><creatorcontrib>Serwadda, David</creatorcontrib><title>Short Communication: Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>Point of care rapid recency testing for HIV-1 may be a cost-effective tool to identify recently infected individuals for incidence estimation, and focused HIV prevention through intensified contact tracing. We validated the Asante™ HIV-1 rapid recency
assay for use in Uganda. Archived specimens (serum/plasma), collected from longitudinally observed HIV-1 recently and long-term infected participants, were tested with the Asante HIV-1 rapid recency assay per manufacturer's instructions. Previously identified antiretroviral therapy (ART)-naive samples with known seroconversions within 6 months of follow-up were tested in independent laboratories: the Rakai Health Sciences Program (RHSP) and the Uganda Virus Research Institute HIV Reference Laboratory (UVRI-HRL). In addition, samples from participants who seroconverted within 6-18 months and samples from individuals with chronic HIV-1 infection of at least 18 months duration were classified into three categories: ART naive, ART exposed with suppressed viral loads, and ART exposed with detectable viremia. Of the 85 samples seroconverting in ≤6 months, 27 and 42 samples were identified as "recent" by the Asante HIV-1 rapid recency test at the RHSP laboratory and UVRI-HRL, corresponding to sensitivities of 32% and 49%, respectively. There was 72% agreement between the laboratories (Cohen's kappa = 0.481, 95% CI = 0.317-0.646,
< .0001). Specificity was 100% (200/200) among chronically infected ART-naive samples. The Asante HIV-1 rapid recency assay had low sensitivity for detection of recent HIV-1 infections in Uganda, with substantial interlaboratory variability due to differential interpretation of the test strip bands. Specificity was excellent. Assessment of assay performance in other settings is needed to guide decisions on test utility.</description><subject>Antiretroviral agents</subject><subject>Antiretroviral therapy</subject><subject>Assaying</subject><subject>Chronic infection</subject><subject>Contact tracing</subject><subject>Epidemiology</subject><subject>HIV</subject><subject>HIV Infections - diagnosis</subject><subject>HIV Infections - epidemiology</subject><subject>HIV Seropositivity</subject><subject>HIV-1</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Laboratories</subject><subject>Sensitivity</subject><subject>Uganda - epidemiology</subject><subject>Viral Load</subject><subject>Viremia</subject><issn>0889-2229</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkc1rGzEQxUVpaNy0x16LoJde1tHXrqQeCsFNG0MgkDa5ClkfscKu5Eq7Bfevjxw7oc1phnm_eczwAPiA0RwjIU91sHOCCJojwuUrMMOS4kYw1L4GMySEbAgh8hi8LeUeISQJad-AY0qZlJySGfj7c53yCBdpGKYYjB5Dil_gre6Dfexh8nBcO3hWdBwdvFjeNhhe602w8NoZF822SkVvoU8ZfnOjM09bj_J42FhGv1cKDBHe3Olo9Ttw5HVf3PtDPQE3389_LS6ay6sfy8XZZWMoRbJZYdIZghnjRFvWIupbT6wQXWeRYVZ2TnPOkPGMUcx9262QF8xQVmdsJRA9AV_3vptpNTi7uyrrXm1yGHTeqqSD-l-JYa3u0h8lOO4YZ9Xg88Egp9-TK6MaQjGu73V0aSqKMFHBjre0op9eoPdpyrG-p0iHGaetILxSzZ4yOZWSnX8-BiO1S1XVVNUuVbVLtfIf__3gmX6KkT4Ao9-cOw</recordid><startdate>202112</startdate><enddate>202112</enddate><creator>Galiwango, Ronald Moses</creator><creator>Ssuuna, Charles</creator><creator>Kaleebu, Pontiano</creator><creator>Kigozi, Godfrey</creator><creator>Kagaayi, Joseph</creator><creator>Nakigozi, Gertrude</creator><creator>Reynolds, Steven James</creator><creator>Lutalo, Tom</creator><creator>Kankaka, Edward Nelson</creator><creator>Wasswa, John Bosco</creator><creator>Kalibbala, Sarah N</creator><creator>Kigozi, Aminah N</creator><creator>Watera, Christine</creator><creator>Ejang, Julia</creator><creator>Ndyanabo, Anthony</creator><creator>Anok, Aggrey J</creator><creator>Ssemwanga, Deogratius</creator><creator>Kibengo, Freddie M</creator><creator>Quinn, Thomas C</creator><creator>Grabowski, Mary</creator><creator>Chang, Larry W</creator><creator>Wawer, Maria</creator><creator>Gray, Ronald</creator><creator>Laeyendecker, Oliver</creator><creator>Serwadda, David</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>202112</creationdate><title>Short Communication: Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda</title><author>Galiwango, Ronald Moses ; Ssuuna, Charles ; Kaleebu, Pontiano ; Kigozi, Godfrey ; Kagaayi, Joseph ; Nakigozi, Gertrude ; Reynolds, Steven James ; Lutalo, Tom ; Kankaka, Edward Nelson ; Wasswa, John Bosco ; Kalibbala, Sarah N ; Kigozi, Aminah N ; Watera, Christine ; Ejang, Julia ; Ndyanabo, Anthony ; Anok, Aggrey J ; Ssemwanga, Deogratius ; Kibengo, Freddie M ; Quinn, Thomas C ; Grabowski, Mary ; Chang, Larry W ; Wawer, Maria ; Gray, Ronald ; Laeyendecker, Oliver ; Serwadda, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3309-b126c214472ad4503f5f2d8866d0c4d96ea7740cf44317f56b0f84c3440c4b803</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Antiretroviral agents</topic><topic>Antiretroviral therapy</topic><topic>Assaying</topic><topic>Chronic infection</topic><topic>Contact tracing</topic><topic>Epidemiology</topic><topic>HIV</topic><topic>HIV Infections - diagnosis</topic><topic>HIV Infections - epidemiology</topic><topic>HIV Seropositivity</topic><topic>HIV-1</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Laboratories</topic><topic>Sensitivity</topic><topic>Uganda - epidemiology</topic><topic>Viral Load</topic><topic>Viremia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Galiwango, Ronald Moses</creatorcontrib><creatorcontrib>Ssuuna, Charles</creatorcontrib><creatorcontrib>Kaleebu, Pontiano</creatorcontrib><creatorcontrib>Kigozi, Godfrey</creatorcontrib><creatorcontrib>Kagaayi, Joseph</creatorcontrib><creatorcontrib>Nakigozi, Gertrude</creatorcontrib><creatorcontrib>Reynolds, Steven James</creatorcontrib><creatorcontrib>Lutalo, Tom</creatorcontrib><creatorcontrib>Kankaka, Edward Nelson</creatorcontrib><creatorcontrib>Wasswa, John Bosco</creatorcontrib><creatorcontrib>Kalibbala, Sarah N</creatorcontrib><creatorcontrib>Kigozi, Aminah N</creatorcontrib><creatorcontrib>Watera, Christine</creatorcontrib><creatorcontrib>Ejang, Julia</creatorcontrib><creatorcontrib>Ndyanabo, Anthony</creatorcontrib><creatorcontrib>Anok, Aggrey J</creatorcontrib><creatorcontrib>Ssemwanga, Deogratius</creatorcontrib><creatorcontrib>Kibengo, Freddie M</creatorcontrib><creatorcontrib>Quinn, Thomas C</creatorcontrib><creatorcontrib>Grabowski, Mary</creatorcontrib><creatorcontrib>Chang, Larry W</creatorcontrib><creatorcontrib>Wawer, Maria</creatorcontrib><creatorcontrib>Gray, Ronald</creatorcontrib><creatorcontrib>Laeyendecker, Oliver</creatorcontrib><creatorcontrib>Serwadda, David</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>AIDS research and human retroviruses</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Galiwango, Ronald Moses</au><au>Ssuuna, Charles</au><au>Kaleebu, Pontiano</au><au>Kigozi, Godfrey</au><au>Kagaayi, Joseph</au><au>Nakigozi, Gertrude</au><au>Reynolds, Steven James</au><au>Lutalo, Tom</au><au>Kankaka, Edward Nelson</au><au>Wasswa, John Bosco</au><au>Kalibbala, Sarah N</au><au>Kigozi, Aminah N</au><au>Watera, Christine</au><au>Ejang, Julia</au><au>Ndyanabo, Anthony</au><au>Anok, Aggrey J</au><au>Ssemwanga, Deogratius</au><au>Kibengo, Freddie M</au><au>Quinn, Thomas C</au><au>Grabowski, Mary</au><au>Chang, Larry W</au><au>Wawer, Maria</au><au>Gray, Ronald</au><au>Laeyendecker, Oliver</au><au>Serwadda, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Short Communication: Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda</atitle><jtitle>AIDS research and human retroviruses</jtitle><addtitle>AIDS Res Hum Retroviruses</addtitle><date>2021-12</date><risdate>2021</risdate><volume>37</volume><issue>12</issue><spage>893</spage><epage>896</epage><pages>893-896</pages><issn>0889-2229</issn><eissn>1931-8405</eissn><abstract>Point of care rapid recency testing for HIV-1 may be a cost-effective tool to identify recently infected individuals for incidence estimation, and focused HIV prevention through intensified contact tracing. We validated the Asante™ HIV-1 rapid recency
assay for use in Uganda. Archived specimens (serum/plasma), collected from longitudinally observed HIV-1 recently and long-term infected participants, were tested with the Asante HIV-1 rapid recency assay per manufacturer's instructions. Previously identified antiretroviral therapy (ART)-naive samples with known seroconversions within 6 months of follow-up were tested in independent laboratories: the Rakai Health Sciences Program (RHSP) and the Uganda Virus Research Institute HIV Reference Laboratory (UVRI-HRL). In addition, samples from participants who seroconverted within 6-18 months and samples from individuals with chronic HIV-1 infection of at least 18 months duration were classified into three categories: ART naive, ART exposed with suppressed viral loads, and ART exposed with detectable viremia. Of the 85 samples seroconverting in ≤6 months, 27 and 42 samples were identified as "recent" by the Asante HIV-1 rapid recency test at the RHSP laboratory and UVRI-HRL, corresponding to sensitivities of 32% and 49%, respectively. There was 72% agreement between the laboratories (Cohen's kappa = 0.481, 95% CI = 0.317-0.646,
< .0001). Specificity was 100% (200/200) among chronically infected ART-naive samples. The Asante HIV-1 rapid recency assay had low sensitivity for detection of recent HIV-1 infections in Uganda, with substantial interlaboratory variability due to differential interpretation of the test strip bands. Specificity was excellent. Assessment of assay performance in other settings is needed to guide decisions on test utility.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>33499732</pmid><doi>10.1089/aid.2020.0279</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | AIDS research and human retroviruses, 2021-12, Vol.37 (12), p.893-896 |
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| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Antiretroviral agents Antiretroviral therapy Assaying Chronic infection Contact tracing Epidemiology HIV HIV Infections - diagnosis HIV Infections - epidemiology HIV Seropositivity HIV-1 Human immunodeficiency virus Humans Laboratories Sensitivity Uganda - epidemiology Viral Load Viremia |
| title | Short Communication: Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda |
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