Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma
Abstract Background A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations....
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| Veröffentlicht in: | Journal of clinical virology 2011-12, Vol.52, p.S57-S61 |
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| container_title | Journal of clinical virology |
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| creator | Bentsen, Christopher McLaughlin, Lisa Mitchell, Elizabeth Ferrera, Carol Liska, Sally Myers, Robert Peel, Sheila Swenson, Paul Gadelle, Stephane Shriver, M. Kathleen |
| description | Abstract Background A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations. Objectives The objectives of the study were to assess assay performance for the detection of acute HIV infections; sensitivity in known HIV positive samples; percent agreement with HIV status; specificity in low and high risk individuals of unknown HIV status; and to compare assay performance to a 3rd generation HIV assay. Study design The evaluation included testing 9150 samples at four U.S. clinical trial sites, using three kit lots. Unlinked samples were from routine testing, repositories or purchased from vendors. Results GS HIV Combo Ag/Ab EIA detection in samples from individuals in two separate populations with acute HIV infection was 95.2% (20/21) and 86.4% (38/44). Sensitivity was 100% (1603/1603) in known antibody positive [HIV-1 Groups M and O, and HIV-2] samples. HIV p24 antigen detection was 100% (53/53) in HIV-1 culture supernatants. HIV-1 seroconversion panel detection improved by a range of 0–20 days compared to a 3rd generation HIV test. Specificity was 99.9% (5989/5996) in low risk, 99.9% (959/960) in high risk and 100% (100/100) in pediatric populations. Conclusion The GS HIV Combo Ag/Ab EIA significantly reduced the diagnostic window when compared to the 3rd generation screening assay, enabling earlier diagnosis of HIV infection. The performance parameters of the Bio-Rad GS HIV Combo Ag/Ab EIA are well suited for use in HIV diagnostic settings. |
| doi_str_mv | 10.1016/j.jcv.2011.09.023 |
| format | Article |
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Kathleen</creator><creatorcontrib>Bentsen, Christopher ; McLaughlin, Lisa ; Mitchell, Elizabeth ; Ferrera, Carol ; Liska, Sally ; Myers, Robert ; Peel, Sheila ; Swenson, Paul ; Gadelle, Stephane ; Shriver, M. Kathleen</creatorcontrib><description>Abstract Background A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations. Objectives The objectives of the study were to assess assay performance for the detection of acute HIV infections; sensitivity in known HIV positive samples; percent agreement with HIV status; specificity in low and high risk individuals of unknown HIV status; and to compare assay performance to a 3rd generation HIV assay. Study design The evaluation included testing 9150 samples at four U.S. clinical trial sites, using three kit lots. Unlinked samples were from routine testing, repositories or purchased from vendors. Results GS HIV Combo Ag/Ab EIA detection in samples from individuals in two separate populations with acute HIV infection was 95.2% (20/21) and 86.4% (38/44). Sensitivity was 100% (1603/1603) in known antibody positive [HIV-1 Groups M and O, and HIV-2] samples. HIV p24 antigen detection was 100% (53/53) in HIV-1 culture supernatants. HIV-1 seroconversion panel detection improved by a range of 0–20 days compared to a 3rd generation HIV test. Specificity was 99.9% (5989/5996) in low risk, 99.9% (959/960) in high risk and 100% (100/100) in pediatric populations. Conclusion The GS HIV Combo Ag/Ab EIA significantly reduced the diagnostic window when compared to the 3rd generation screening assay, enabling earlier diagnosis of HIV infection. The performance parameters of the Bio-Rad GS HIV Combo Ag/Ab EIA are well suited for use in HIV diagnostic settings.</description><identifier>ISSN: 1386-6532</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/j.jcv.2011.09.023</identifier><identifier>PMID: 21995929</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>4th generation ; Acute ; Allergy and Immunology ; Antibody ; Combination ; HIV Antibodies - analysis ; HIV Antibodies - blood ; HIV Antibodies - immunology ; HIV antigen ; HIV Core Protein p24 - analysis ; HIV Core Protein p24 - blood ; HIV Core Protein p24 - immunology ; HIV Infections - diagnosis ; HIV Infections - immunology ; HIV Infections - virology ; HIV Seropositivity - diagnosis ; HIV Seropositivity - immunology ; HIV Seropositivity - virology ; HIV-1 - immunology ; HIV-1 - pathogenicity ; HIV-2 - immunology ; HIV-2 - pathogenicity ; Human immunodeficiency virus 1 ; Human immunodeficiency virus 2 ; Humans ; Immunoenzyme Techniques - methods ; Infectious Disease ; Nucleic Acid Amplification Techniques ; Plasma - immunology ; Plasma - virology ; Reagent Kits, Diagnostic ; Risk Factors ; Sensitivity and Specificity ; Serum - immunology ; Serum - virology ; United States</subject><ispartof>Journal of clinical virology, 2011-12, Vol.52, p.S57-S61</ispartof><rights>Elsevier B.V.</rights><rights>2011 Elsevier B.V.</rights><rights>Copyright © 2011 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-6aa57ea871cf47eac033dc74d5ef53f171b73a9d4f4ac90d9d8258f7c1757c173</citedby><cites>FETCH-LOGICAL-c439t-6aa57ea871cf47eac033dc74d5ef53f171b73a9d4f4ac90d9d8258f7c1757c173</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1386653211003866$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21995929$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bentsen, Christopher</creatorcontrib><creatorcontrib>McLaughlin, Lisa</creatorcontrib><creatorcontrib>Mitchell, Elizabeth</creatorcontrib><creatorcontrib>Ferrera, Carol</creatorcontrib><creatorcontrib>Liska, Sally</creatorcontrib><creatorcontrib>Myers, Robert</creatorcontrib><creatorcontrib>Peel, Sheila</creatorcontrib><creatorcontrib>Swenson, Paul</creatorcontrib><creatorcontrib>Gadelle, Stephane</creatorcontrib><creatorcontrib>Shriver, M. Kathleen</creatorcontrib><title>Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>Abstract Background A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations. Objectives The objectives of the study were to assess assay performance for the detection of acute HIV infections; sensitivity in known HIV positive samples; percent agreement with HIV status; specificity in low and high risk individuals of unknown HIV status; and to compare assay performance to a 3rd generation HIV assay. Study design The evaluation included testing 9150 samples at four U.S. clinical trial sites, using three kit lots. Unlinked samples were from routine testing, repositories or purchased from vendors. Results GS HIV Combo Ag/Ab EIA detection in samples from individuals in two separate populations with acute HIV infection was 95.2% (20/21) and 86.4% (38/44). Sensitivity was 100% (1603/1603) in known antibody positive [HIV-1 Groups M and O, and HIV-2] samples. HIV p24 antigen detection was 100% (53/53) in HIV-1 culture supernatants. HIV-1 seroconversion panel detection improved by a range of 0–20 days compared to a 3rd generation HIV test. Specificity was 99.9% (5989/5996) in low risk, 99.9% (959/960) in high risk and 100% (100/100) in pediatric populations. Conclusion The GS HIV Combo Ag/Ab EIA significantly reduced the diagnostic window when compared to the 3rd generation screening assay, enabling earlier diagnosis of HIV infection. The performance parameters of the Bio-Rad GS HIV Combo Ag/Ab EIA are well suited for use in HIV diagnostic settings.</description><subject>4th generation</subject><subject>Acute</subject><subject>Allergy and Immunology</subject><subject>Antibody</subject><subject>Combination</subject><subject>HIV Antibodies - analysis</subject><subject>HIV Antibodies - blood</subject><subject>HIV Antibodies - immunology</subject><subject>HIV antigen</subject><subject>HIV Core Protein p24 - analysis</subject><subject>HIV Core Protein p24 - blood</subject><subject>HIV Core Protein p24 - immunology</subject><subject>HIV Infections - diagnosis</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - virology</subject><subject>HIV Seropositivity - diagnosis</subject><subject>HIV Seropositivity - immunology</subject><subject>HIV Seropositivity - virology</subject><subject>HIV-1 - immunology</subject><subject>HIV-1 - pathogenicity</subject><subject>HIV-2 - immunology</subject><subject>HIV-2 - pathogenicity</subject><subject>Human immunodeficiency virus 1</subject><subject>Human immunodeficiency virus 2</subject><subject>Humans</subject><subject>Immunoenzyme Techniques - methods</subject><subject>Infectious Disease</subject><subject>Nucleic Acid Amplification Techniques</subject><subject>Plasma - immunology</subject><subject>Plasma - virology</subject><subject>Reagent Kits, Diagnostic</subject><subject>Risk Factors</subject><subject>Sensitivity and Specificity</subject><subject>Serum - immunology</subject><subject>Serum - virology</subject><subject>United States</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNksFu1DAQhiMEoqXwAFyQb4BEtnYcx7EqIS2r0q60qIgCV8uxJ1svSbzYyUr7vLwI9m7LgQPi4hnJ3_yjmfmz7CXBM4JJdb6ZbfRuVmBCZljMcEEfZaek5jRnouKPY07rKq8YLU6yZyFsMCaMlvxpdlIQIZgoxGn26zP41vleDRoQ7FQ3qdG6AbkWjXeAPliXf1EGrVTjvBqdtxDQ1S26Xn5HC9c3Ds3X5_MGXS7n75BC5XiH1jCAP4okSoWg9ii2OOgF20_dqAZwU0AGRtAP3RK7LUqkhtFGiRjNIW-cST1Hl4icoDdr76ZtQJ8OxM3bQ0hfBbIDupviJCiAn3oUW247FXr1PHvSqi7Ai_t4ln37ePl1cZ2vbq6Wi_kq1yUVY14pxTiomhPdljHRmFKjeWkYtIy2hJOGUyVM2ZZKC2yEqQtWt1wTztJDz7LXR92tdz8nCKPsbdDQdcd5pSCsFJRX9X-QRUVrUbJIkiOpvQvBQyu33vbK7yXBMplAbmQ0gUwmkFjIaIJY8-pefWp6MH8qHq4egYsjAHEbOwteBm0hOsBYHy8ijbP_lH__V7Xu7GC16n7AHsLGTX6Ia5ZEhkJieZtcmExICMYppb8BuhnWKg</recordid><startdate>20111201</startdate><enddate>20111201</enddate><creator>Bentsen, Christopher</creator><creator>McLaughlin, Lisa</creator><creator>Mitchell, Elizabeth</creator><creator>Ferrera, Carol</creator><creator>Liska, Sally</creator><creator>Myers, Robert</creator><creator>Peel, Sheila</creator><creator>Swenson, Paul</creator><creator>Gadelle, Stephane</creator><creator>Shriver, M. Kathleen</creator><general>Elsevier B.V</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>7X8</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>20111201</creationdate><title>Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma</title><author>Bentsen, Christopher ; McLaughlin, Lisa ; Mitchell, Elizabeth ; Ferrera, Carol ; Liska, Sally ; Myers, Robert ; Peel, Sheila ; Swenson, Paul ; Gadelle, Stephane ; Shriver, M. Kathleen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-6aa57ea871cf47eac033dc74d5ef53f171b73a9d4f4ac90d9d8258f7c1757c173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>4th generation</topic><topic>Acute</topic><topic>Allergy and Immunology</topic><topic>Antibody</topic><topic>Combination</topic><topic>HIV Antibodies - analysis</topic><topic>HIV Antibodies - blood</topic><topic>HIV Antibodies - immunology</topic><topic>HIV antigen</topic><topic>HIV Core Protein p24 - analysis</topic><topic>HIV Core Protein p24 - blood</topic><topic>HIV Core Protein p24 - immunology</topic><topic>HIV Infections - diagnosis</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - virology</topic><topic>HIV Seropositivity - diagnosis</topic><topic>HIV Seropositivity - immunology</topic><topic>HIV Seropositivity - virology</topic><topic>HIV-1 - immunology</topic><topic>HIV-1 - pathogenicity</topic><topic>HIV-2 - immunology</topic><topic>HIV-2 - pathogenicity</topic><topic>Human immunodeficiency virus 1</topic><topic>Human immunodeficiency virus 2</topic><topic>Humans</topic><topic>Immunoenzyme Techniques - methods</topic><topic>Infectious Disease</topic><topic>Nucleic Acid Amplification Techniques</topic><topic>Plasma - immunology</topic><topic>Plasma - virology</topic><topic>Reagent Kits, Diagnostic</topic><topic>Risk Factors</topic><topic>Sensitivity and Specificity</topic><topic>Serum - immunology</topic><topic>Serum - virology</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bentsen, Christopher</creatorcontrib><creatorcontrib>McLaughlin, Lisa</creatorcontrib><creatorcontrib>Mitchell, Elizabeth</creatorcontrib><creatorcontrib>Ferrera, Carol</creatorcontrib><creatorcontrib>Liska, Sally</creatorcontrib><creatorcontrib>Myers, Robert</creatorcontrib><creatorcontrib>Peel, Sheila</creatorcontrib><creatorcontrib>Swenson, Paul</creatorcontrib><creatorcontrib>Gadelle, Stephane</creatorcontrib><creatorcontrib>Shriver, M. Kathleen</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bentsen, Christopher</au><au>McLaughlin, Lisa</au><au>Mitchell, Elizabeth</au><au>Ferrera, Carol</au><au>Liska, Sally</au><au>Myers, Robert</au><au>Peel, Sheila</au><au>Swenson, Paul</au><au>Gadelle, Stephane</au><au>Shriver, M. Kathleen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2011-12-01</date><risdate>2011</risdate><volume>52</volume><spage>S57</spage><epage>S61</epage><pages>S57-S61</pages><issn>1386-6532</issn><eissn>1873-5967</eissn><abstract>Abstract Background A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations. Objectives The objectives of the study were to assess assay performance for the detection of acute HIV infections; sensitivity in known HIV positive samples; percent agreement with HIV status; specificity in low and high risk individuals of unknown HIV status; and to compare assay performance to a 3rd generation HIV assay. Study design The evaluation included testing 9150 samples at four U.S. clinical trial sites, using three kit lots. Unlinked samples were from routine testing, repositories or purchased from vendors. Results GS HIV Combo Ag/Ab EIA detection in samples from individuals in two separate populations with acute HIV infection was 95.2% (20/21) and 86.4% (38/44). Sensitivity was 100% (1603/1603) in known antibody positive [HIV-1 Groups M and O, and HIV-2] samples. HIV p24 antigen detection was 100% (53/53) in HIV-1 culture supernatants. HIV-1 seroconversion panel detection improved by a range of 0–20 days compared to a 3rd generation HIV test. Specificity was 99.9% (5989/5996) in low risk, 99.9% (959/960) in high risk and 100% (100/100) in pediatric populations. Conclusion The GS HIV Combo Ag/Ab EIA significantly reduced the diagnostic window when compared to the 3rd generation screening assay, enabling earlier diagnosis of HIV infection. The performance parameters of the Bio-Rad GS HIV Combo Ag/Ab EIA are well suited for use in HIV diagnostic settings.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>21995929</pmid><doi>10.1016/j.jcv.2011.09.023</doi></addata></record> |
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| subjects | 4th generation Acute Allergy and Immunology Antibody Combination HIV Antibodies - analysis HIV Antibodies - blood HIV Antibodies - immunology HIV antigen HIV Core Protein p24 - analysis HIV Core Protein p24 - blood HIV Core Protein p24 - immunology HIV Infections - diagnosis HIV Infections - immunology HIV Infections - virology HIV Seropositivity - diagnosis HIV Seropositivity - immunology HIV Seropositivity - virology HIV-1 - immunology HIV-1 - pathogenicity HIV-2 - immunology HIV-2 - pathogenicity Human immunodeficiency virus 1 Human immunodeficiency virus 2 Humans Immunoenzyme Techniques - methods Infectious Disease Nucleic Acid Amplification Techniques Plasma - immunology Plasma - virology Reagent Kits, Diagnostic Risk Factors Sensitivity and Specificity Serum - immunology Serum - virology United States |
| title | Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma |
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