{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T21:32:36Z","timestamp":1789421556841,"version":"build-2803163510"},"reference-count":27,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T00:00:00Z","timestamp":1715126400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T00:00:00Z","timestamp":1715126400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100011234","name":"Bio-Rad Laboratories","doi-asserted-by":"crossref","award":["No specific grant"],"award-info":[{"award-number":["No specific grant"]}],"id":[{"id":"10.13039\/100011234","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2024,5,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>Diagnosing of human immunodeficiency virus (HIV) types 1 and 2 requires a screening with a highly sensitive and specific enzyme immunoassay and a low detection limit for the HIV-1 p24 antigen to minimize the diagnostic window. The objective of the study was to determine the sensitivity, specificity, and p24 limit of detection of the Access HIV combo V2 assay. Retrospective part of sensitivity: 452 HIV-1 positive samples from 403 chronic (9 different HIV-1 group M subtypes, 22 different HIV-1 group M CRFs, and 3 HIV-1 group O), 49 primary HIV-1 infections, 103 HIV-2 positive samples assessed at Piti\u00e9-Salp\u00eatri\u00e8re Hospital, 600 untyped HIV-1, 10 subtype-D, and 159 untyped HIV-2 samples assessed in Bio-Rad Laboratories. Prospective part of clinical specificity: all consecutive samples in two blood donor facilities and Piti\u00e9-Salp\u00eatri\u00e8re (6,570 patients) tested with Access HIV combo V2 and respectively Prism HIV O Plus (Abbott) or Architect HIV Ag\/Ab Combo (Abbott) for Ag\/Ab screening, and Procleix Ultrio (Gen Probe) for HIV RNA screening. Limit of detection for p24 antigen was assessed on recombinant virus-like particles (10 HIV-1 group M subtypes\/CRFs, HIV-1 group O). Sensitivity [95% confidence interval (CI)] of Access HIV combo V2 was 100% (99.63\u2013100) for HIV-1 chronic infection, 100% (98.55\u2013100) for HIV-2 chronic infection, and 100% (93.00\u2013100) for HIV-1 primary infection. Specificity (95% CI) was 99.98 (99.91\u2013100). Limit of detection for p24 antigen was around 0.43 IU\/mL [interquartile range (0.38\u20130.56)], and consistent across the 11 analyzed subtypes\/CRFs. Hence, with both high sensitivity and specificity, Access HIV combo V2 is a suitable screening assay for HIV-1\/2 infection.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>IMPORTANCE<\/jats:title>\n            <jats:p>Bio-Rad is one of the leading human immunodeficiency virus (HIV) screening test manufacturers. This laboratory released in 2021 their new version of the Access combo HIV test. However, to date, there have been no studies regarding its performance, especially its limit of detection of the diverse p24 antigen. We present the sensitivity (chronic and primary HIV-1 infection and HIV-2 chronic infection), specificity (blood donors and hospitalized patients), and raw data for the p24\/seroconversion panels the manufacturer gave to the European agencies.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/jcm.00095-24","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T13:11:04Z","timestamp":1711545064000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":6,"title":["Sensitivity and specificity of the new Bio-Rad HIV screening test, Access HIV combo V2"],"prefix":"10.1128","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4301-3771","authenticated-orcid":false,"given":"Vincent","family":"Guiraud","sequence":"first","affiliation":[{"name":"AP-HP, H\u00f4pitaux Universitaires La Piti\u00e9 Salp\u00eatri\u00e8re-Charles Foix, Service de Virologie, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yann","family":"Ciczora","sequence":"additional","affiliation":[{"name":"Bio-Rad Laboratories, Steenvoorde, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muriel","family":"Cardona","sequence":"additional","affiliation":[{"name":"Bio-Rad Laboratories, Marnes-La-Coquette, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Defer","sequence":"additional","affiliation":[{"name":"Etablissement Fran\u00e7ais du Sang (EFS) Hauts de France\u2014Normandie, Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine","family":"Gr\u00e9aume","sequence":"additional","affiliation":[{"name":"Etablissement Fran\u00e7ais du Sang (EFS) Hauts de France\u2014Normandie, Bois-Guillaume, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Nogues","sequence":"additional","affiliation":[{"name":"Bio-Rad Laboratories, Steenvoorde, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0048-0318","authenticated-orcid":false,"given":"Agn\u00e8s","family":"Gautheret-Dejean","sequence":"additional","affiliation":[{"name":"AP-HP, H\u00f4pitaux Universitaires La Piti\u00e9 Salp\u00eatri\u00e8re-Charles Foix, Service de Virologie, Paris, France"},{"name":"Universit\u00e9 Paris cit\u00e9, INSERM UMR-S 1139 Physiopathologie et pharmacotoxicologie placentaire humaine: microbiote pr\u00e9 &amp; post-natal, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","volume-title":"Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach","year":"2021","unstructured":"2021. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. World health organization, Geneva, Switzerland."},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000534"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/ve\/veab024"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1086\/386333"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.20.1.21708"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.3390\/v11121096"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1080\/09540120701867206"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1080\/15284336.2018.1429846"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.20.1.21419"},{"key":"e_1_3_4_11_2","volume-title":"Laboratory testing for the diagnosis of HIV infection: updated recommendations","author":"Bernard MB","year":"2014","unstructured":"BernardMB, Michele OS, LauraWG, Berry B, Barbara WG, KellyWE, Michael PA, Centers for Disease Control and Prevention (U.S), Association of Public Health Laboratorie. 2014. Laboratory testing for the diagnosis of HIV infection: updated recommendations. Centers for Disease Control and Prevention."},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01089-14"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2007.02.013"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200309050-00005"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00619-23"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980430)17:8<857::AID-SIM777>3.0.CO;2-E"},{"key":"e_1_3_4_18_2","unstructured":"European Commission. 2019. Commission implementing decision (EU) 2019\/1244 of 1 July 2019 amending decision 2002\/364\/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays. Available from: https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2019\/1244\/oj"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.11150\/kansenshogakuzasshi.87.415"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2022.105219"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.105047"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2018.02.018"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.105020"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.105058"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2012.06.012"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0111552"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.105022"},{"key":"e_1_3_4_28_2","unstructured":"Morlat P. 2018. Prise en charge m\u00e9dicale des personnes vivant avec le VIH - recommandations du groupe d\u2019experts in France. Available from: https:\/\/cns.sante.fr\/wp-content\/uploads\/2018\/04\/experts-vih_prevention-depistage.pdf. Retrieved 28 Feb 2024."},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6631a3"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00095-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00095-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T13:02:14Z","timestamp":1715173334000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.00095-24"}},"subtitle":[],"editor":[{"given":"Randall","family":"Hayden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,5,8]]},"references-count":27,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5,8]]}},"alternative-id":["10.1128\/jcm.00095-24"],"URL":"https:\/\/doi.org\/10.1128\/jcm.00095-24","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,8]]},"assertion":[{"value":"2024-01-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00095-24"}}