p24 Antigen Rapid Test for Diagnosis of Acute Pediatric HIV Infection
Currently, the majority of HIV-infected infants are found within limited-resource settings, where inadequate screening for HIV due to the lack of access to simple and affordable point-of-care tests impedes implementation of antiretroviral therapy. Here we report development of a low-cost dipstick p2...
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| Veröffentlicht in: | Journal of acquired immune deficiency syndromes (1999) 2010-12, Vol.55 (4), p.413-419 |
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| container_title | Journal of acquired immune deficiency syndromes (1999) |
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| creator | PARPIA, Zaheer A ELGHANIAN, Robert NABATIYAN, Arman HARDIE, Diana R KELSO, David M |
| description | Currently, the majority of HIV-infected infants are found within limited-resource settings, where inadequate screening for HIV due to the lack of access to simple and affordable point-of-care tests impedes implementation of antiretroviral therapy. Here we report development of a low-cost dipstick p24 antigen assay using a visual readout format that can facilitate the diagnosis of HIV for infants in resource-poor conditions. A heat shock methodology was developed to optimize disruption of immune complexes present in the plasma of infected infants. The analytical sensitivity of the assay using recombinant p24 antigen is 50 pg/mL (2 pM) with whole virus detection as low as 42.5k RNA copies per milliliter plasma. In a blinded study comprising 51 archived infant samples from the Women and Infants Transmission Study, our assay demonstrated an overall sensitivity and specificity of 90% and 100%, respectively. In field evaluations of 389 fresh samples from South African infants, a sensitivity of 95% and specificity of 99% was achieved. The assay is simple to perform, requires minimal plasma volume (25 μL), and yields a result in less than 40 minutes making it ideal for implementation in resource-limited settings. |
| doi_str_mv | 10.1097/QAI.0b013e3181f1afbc |
| format | Article |
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Here we report development of a low-cost dipstick p24 antigen assay using a visual readout format that can facilitate the diagnosis of HIV for infants in resource-poor conditions. A heat shock methodology was developed to optimize disruption of immune complexes present in the plasma of infected infants. The analytical sensitivity of the assay using recombinant p24 antigen is 50 pg/mL (2 pM) with whole virus detection as low as 42.5k RNA copies per milliliter plasma. In a blinded study comprising 51 archived infant samples from the Women and Infants Transmission Study, our assay demonstrated an overall sensitivity and specificity of 90% and 100%, respectively. In field evaluations of 389 fresh samples from South African infants, a sensitivity of 95% and specificity of 99% was achieved. The assay is simple to perform, requires minimal plasma volume (25 μL), and yields a result in less than 40 minutes making it ideal for implementation in resource-limited settings.</description><identifier>ISSN: 1525-4135</identifier><identifier>EISSN: 1944-7884</identifier><identifier>DOI: 10.1097/QAI.0b013e3181f1afbc</identifier><identifier>PMID: 20811289</identifier><identifier>CODEN: JDSRET</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Acquired immune deficiency syndrome ; Africa South of the Sahara ; AIDS ; AIDS/HIV ; Antibodies, Monoclonal - immunology ; Antigens ; Babies ; Biological and medical sciences ; Female ; Fundamental and applied biological sciences. Psychology ; HIV ; HIV - isolation & purification ; HIV Antibodies - immunology ; HIV Core Protein p24 - blood ; HIV Core Protein p24 - immunology ; HIV Infections - diagnosis ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunoassay ; Infant ; Infant, Newborn ; Infectious diseases ; Medical diagnosis ; Medical sciences ; Microbiology ; Miscellaneous ; Pediatrics ; Plasma ; Reagent Strips ; Recombinant Proteins - blood ; Recombinant Proteins - immunology ; Ribonucleic acid ; RNA ; Sensitivity and Specificity ; United States ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Virology</subject><ispartof>Journal of acquired immune deficiency syndromes (1999), 2010-12, Vol.55 (4), p.413-419</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright Lippincott Williams & Wilkins Dec 1, 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c492t-bff4677f2c9aedbeb10d28082b97f0a4a08d23d3fbc06025df559085ca8ff143</citedby><cites>FETCH-LOGICAL-c492t-bff4677f2c9aedbeb10d28082b97f0a4a08d23d3fbc06025df559085ca8ff143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23412012$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20811289$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>PARPIA, Zaheer A</creatorcontrib><creatorcontrib>ELGHANIAN, Robert</creatorcontrib><creatorcontrib>NABATIYAN, Arman</creatorcontrib><creatorcontrib>HARDIE, Diana R</creatorcontrib><creatorcontrib>KELSO, David M</creatorcontrib><title>p24 Antigen Rapid Test for Diagnosis of Acute Pediatric HIV Infection</title><title>Journal of acquired immune deficiency syndromes (1999)</title><addtitle>J Acquir Immune Defic Syndr</addtitle><description>Currently, the majority of HIV-infected infants are found within limited-resource settings, where inadequate screening for HIV due to the lack of access to simple and affordable point-of-care tests impedes implementation of antiretroviral therapy. Here we report development of a low-cost dipstick p24 antigen assay using a visual readout format that can facilitate the diagnosis of HIV for infants in resource-poor conditions. A heat shock methodology was developed to optimize disruption of immune complexes present in the plasma of infected infants. The analytical sensitivity of the assay using recombinant p24 antigen is 50 pg/mL (2 pM) with whole virus detection as low as 42.5k RNA copies per milliliter plasma. In a blinded study comprising 51 archived infant samples from the Women and Infants Transmission Study, our assay demonstrated an overall sensitivity and specificity of 90% and 100%, respectively. In field evaluations of 389 fresh samples from South African infants, a sensitivity of 95% and specificity of 99% was achieved. The assay is simple to perform, requires minimal plasma volume (25 μL), and yields a result in less than 40 minutes making it ideal for implementation in resource-limited settings.</description><subject>Acquired immune deficiency syndrome</subject><subject>Africa South of the Sahara</subject><subject>AIDS</subject><subject>AIDS/HIV</subject><subject>Antibodies, Monoclonal - immunology</subject><subject>Antigens</subject><subject>Babies</subject><subject>Biological and medical sciences</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV</subject><subject>HIV - isolation & purification</subject><subject>HIV Antibodies - immunology</subject><subject>HIV Core Protein p24 - blood</subject><subject>HIV Core Protein p24 - immunology</subject><subject>HIV Infections - diagnosis</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infectious diseases</subject><subject>Medical diagnosis</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Pediatrics</subject><subject>Plasma</subject><subject>Reagent Strips</subject><subject>Recombinant Proteins - blood</subject><subject>Recombinant Proteins - immunology</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>Sensitivity and Specificity</subject><subject>United States</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Virology</subject><issn>1525-4135</issn><issn>1944-7884</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUtLAzEUhYMovv-BSBDE1dR785jJLEutWhB8UNwOmUxSIu1MTWYW_nsjVoVuXN27-M7hnnsIOUMYIZTF9fN4NoIakFuOCh1qV5sdcoilEFmhlNhNu2QyE8jlATmK8Q0AcyHKfXLAQCEyVR6S6ZoJOm57v7AtfdFr39C5jT11XaA3Xi_aLvpIO0fHZugtfbKN133wht7PXumsddb0vmtPyJ7Ty2hPN_OYzG-n88l99vB4N5uMHzIjStZntXMiLwrHTKltU9saoWEKFKvLwoEWGlTDeMNTEsiBycZJWYKSRivnUPBjcvVtuw7d-5DOrFY-Grtc6tZ2Q6wUSikg5_AvWeQsVwUgJvJii3zrhtCmFJUCJgrOc5kg8Q2Z0MUYrKvWwa90-KgQqq82qtRGtd1Gkp1vvId6ZZtf0c_7E3C5AXQ0eumCbo2PfxwXyAAZ_wQ5eZG-</recordid><startdate>20101201</startdate><enddate>20101201</enddate><creator>PARPIA, Zaheer A</creator><creator>ELGHANIAN, Robert</creator><creator>NABATIYAN, Arman</creator><creator>HARDIE, Diana R</creator><creator>KELSO, David M</creator><general>Lippincott Williams & Wilkins</general><general>Lippincott Williams & Wilkins Ovid Technologies</general><scope>IQODW</scope><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>7T2</scope><scope>7T5</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>20101201</creationdate><title>p24 Antigen Rapid Test for Diagnosis of Acute Pediatric HIV Infection</title><author>PARPIA, Zaheer A ; ELGHANIAN, Robert ; NABATIYAN, Arman ; HARDIE, Diana R ; KELSO, David M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c492t-bff4677f2c9aedbeb10d28082b97f0a4a08d23d3fbc06025df559085ca8ff143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Africa South of the Sahara</topic><topic>AIDS</topic><topic>AIDS/HIV</topic><topic>Antibodies, Monoclonal - immunology</topic><topic>Antigens</topic><topic>Babies</topic><topic>Biological and medical sciences</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HIV</topic><topic>HIV - isolation & purification</topic><topic>HIV Antibodies - immunology</topic><topic>HIV Core Protein p24 - blood</topic><topic>HIV Core Protein p24 - immunology</topic><topic>HIV Infections - diagnosis</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Infectious diseases</topic><topic>Medical diagnosis</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Pediatrics</topic><topic>Plasma</topic><topic>Reagent Strips</topic><topic>Recombinant Proteins - blood</topic><topic>Recombinant Proteins - immunology</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>Sensitivity and Specificity</topic><topic>United States</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>PARPIA, Zaheer A</creatorcontrib><creatorcontrib>ELGHANIAN, Robert</creatorcontrib><creatorcontrib>NABATIYAN, Arman</creatorcontrib><creatorcontrib>HARDIE, Diana R</creatorcontrib><creatorcontrib>KELSO, David M</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>PARPIA, Zaheer A</au><au>ELGHANIAN, Robert</au><au>NABATIYAN, Arman</au><au>HARDIE, Diana R</au><au>KELSO, David M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>p24 Antigen Rapid Test for Diagnosis of Acute Pediatric HIV Infection</atitle><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle><addtitle>J Acquir Immune Defic Syndr</addtitle><date>2010-12-01</date><risdate>2010</risdate><volume>55</volume><issue>4</issue><spage>413</spage><epage>419</epage><pages>413-419</pages><issn>1525-4135</issn><eissn>1944-7884</eissn><coden>JDSRET</coden><abstract>Currently, the majority of HIV-infected infants are found within limited-resource settings, where inadequate screening for HIV due to the lack of access to simple and affordable point-of-care tests impedes implementation of antiretroviral therapy. Here we report development of a low-cost dipstick p24 antigen assay using a visual readout format that can facilitate the diagnosis of HIV for infants in resource-poor conditions. A heat shock methodology was developed to optimize disruption of immune complexes present in the plasma of infected infants. The analytical sensitivity of the assay using recombinant p24 antigen is 50 pg/mL (2 pM) with whole virus detection as low as 42.5k RNA copies per milliliter plasma. In a blinded study comprising 51 archived infant samples from the Women and Infants Transmission Study, our assay demonstrated an overall sensitivity and specificity of 90% and 100%, respectively. In field evaluations of 389 fresh samples from South African infants, a sensitivity of 95% and specificity of 99% was achieved. 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| ispartof | Journal of acquired immune deficiency syndromes (1999), 2010-12, Vol.55 (4), p.413-419 |
| issn | 1525-4135 1944-7884 |
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| subjects | Acquired immune deficiency syndrome Africa South of the Sahara AIDS AIDS/HIV Antibodies, Monoclonal - immunology Antigens Babies Biological and medical sciences Female Fundamental and applied biological sciences. Psychology HIV HIV - isolation & purification HIV Antibodies - immunology HIV Core Protein p24 - blood HIV Core Protein p24 - immunology HIV Infections - diagnosis Human immunodeficiency virus Human viral diseases Humans Immunoassay Infant Infant, Newborn Infectious diseases Medical diagnosis Medical sciences Microbiology Miscellaneous Pediatrics Plasma Reagent Strips Recombinant Proteins - blood Recombinant Proteins - immunology Ribonucleic acid RNA Sensitivity and Specificity United States Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Virology |
| title | p24 Antigen Rapid Test for Diagnosis of Acute Pediatric HIV Infection |
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