Vincent Guiraud, Angèle Naizet, Habiba Khan, Ghizlane Benhafoun, Pierre Hernandez, Luigi Piccin, Agnès Pichon, Ay Ling Leng, Léna Yousfi, Agnès Gautheret-Dejean
{"title":"第四代 HIV 快速检测试剂盒:第四代 HIV 快速检测试剂盒:提高 HIV-1 初诊感染筛查的灵敏度并缩短诊断窗口期。","authors":"Vincent Guiraud, Angèle Naizet, Habiba Khan, Ghizlane Benhafoun, Pierre Hernandez, Luigi Piccin, Agnès Pichon, Ay Ling Leng, Léna Yousfi, Agnès Gautheret-Dejean","doi":"10.1002/jmv.70044","DOIUrl":null,"url":null,"abstract":"<p>As most HIV rapid tests (HRT) detect only HIV-1/2 antibodies, their performance during primary HIV infection is poor. Determine HIV Early detect (Abbott) (Determine) is the only HRT with an HIV-1 p24-antigen detection, but the impact of this addition in shortening the diagnostic window remains unclear. A total of 183 HIV-1 primary infection samples were tested using the HRTs Determine and ONE STEP anti-HIV (1&2) Test (InTec Products) (One-Step). The pre-seroconversion subgroup was defined as p24-antigen positivity without Western blot nor Liaison XL (fouth generation enzyme immunoassay with distinct signal for p24-antigen and HIV-1 antibody) HIV-1 antibodies. Global sensitivity (95% CI) was 95% (91–97) for Determine versus 80% (74%–85%) for One-Step (difference <i>p</i> = 1.38e−06). Pre-seroconversion subgroup sensitivity was lower, at 71.9 (54.6%-84.4%) for Determine and 9.7% (3.3%–24.9%) for One-Step. Among the 45 samples with an HIV-1 infection date, no HRT was reactive up to 2 weeks. Between 2 and 3 weeks, Determine sensitivity was 78% (45%–95%) versus 56% (27%–81%) for One-Step. From 3 weeks to 1 month Determine sensitivity was 90% (62%–98%) and One-Step 45% (21%–72%). The last negative sample occurred at 3 weeks for Determine versus 70–90 days for One-Step. HRT with p24-antigen detection significantly shortens the diagnostic window from approximatively 3 months to 1 month. HRTs should be used with caution in the first month after HIV infection.</p>","PeriodicalId":16354,"journal":{"name":"Journal of Medical Virology","volume":"96 11","pages":""},"PeriodicalIF":6.8000,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.70044","citationCount":"0","resultStr":"{\"title\":\"Fourth-Generation HIV Rapid Tests: Enhanced Sensitivity and Reduced Diagnostic Window for HIV-1 Primary Infection Screening\",\"authors\":\"Vincent Guiraud, Angèle Naizet, Habiba Khan, Ghizlane Benhafoun, Pierre Hernandez, Luigi Piccin, Agnès Pichon, Ay Ling Leng, Léna Yousfi, Agnès Gautheret-Dejean\",\"doi\":\"10.1002/jmv.70044\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>As most HIV rapid tests (HRT) detect only HIV-1/2 antibodies, their performance during primary HIV infection is poor. Determine HIV Early detect (Abbott) (Determine) is the only HRT with an HIV-1 p24-antigen detection, but the impact of this addition in shortening the diagnostic window remains unclear. A total of 183 HIV-1 primary infection samples were tested using the HRTs Determine and ONE STEP anti-HIV (1&2) Test (InTec Products) (One-Step). The pre-seroconversion subgroup was defined as p24-antigen positivity without Western blot nor Liaison XL (fouth generation enzyme immunoassay with distinct signal for p24-antigen and HIV-1 antibody) HIV-1 antibodies. Global sensitivity (95% CI) was 95% (91–97) for Determine versus 80% (74%–85%) for One-Step (difference <i>p</i> = 1.38e−06). Pre-seroconversion subgroup sensitivity was lower, at 71.9 (54.6%-84.4%) for Determine and 9.7% (3.3%–24.9%) for One-Step. Among the 45 samples with an HIV-1 infection date, no HRT was reactive up to 2 weeks. Between 2 and 3 weeks, Determine sensitivity was 78% (45%–95%) versus 56% (27%–81%) for One-Step. From 3 weeks to 1 month Determine sensitivity was 90% (62%–98%) and One-Step 45% (21%–72%). The last negative sample occurred at 3 weeks for Determine versus 70–90 days for One-Step. HRT with p24-antigen detection significantly shortens the diagnostic window from approximatively 3 months to 1 month. HRTs should be used with caution in the first month after HIV infection.</p>\",\"PeriodicalId\":16354,\"journal\":{\"name\":\"Journal of Medical Virology\",\"volume\":\"96 11\",\"pages\":\"\"},\"PeriodicalIF\":6.8000,\"publicationDate\":\"2024-11-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.70044\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Medical Virology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/jmv.70044\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"VIROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Medical Virology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jmv.70044","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"VIROLOGY","Score":null,"Total":0}
Fourth-Generation HIV Rapid Tests: Enhanced Sensitivity and Reduced Diagnostic Window for HIV-1 Primary Infection Screening
As most HIV rapid tests (HRT) detect only HIV-1/2 antibodies, their performance during primary HIV infection is poor. Determine HIV Early detect (Abbott) (Determine) is the only HRT with an HIV-1 p24-antigen detection, but the impact of this addition in shortening the diagnostic window remains unclear. A total of 183 HIV-1 primary infection samples were tested using the HRTs Determine and ONE STEP anti-HIV (1&2) Test (InTec Products) (One-Step). The pre-seroconversion subgroup was defined as p24-antigen positivity without Western blot nor Liaison XL (fouth generation enzyme immunoassay with distinct signal for p24-antigen and HIV-1 antibody) HIV-1 antibodies. Global sensitivity (95% CI) was 95% (91–97) for Determine versus 80% (74%–85%) for One-Step (difference p = 1.38e−06). Pre-seroconversion subgroup sensitivity was lower, at 71.9 (54.6%-84.4%) for Determine and 9.7% (3.3%–24.9%) for One-Step. Among the 45 samples with an HIV-1 infection date, no HRT was reactive up to 2 weeks. Between 2 and 3 weeks, Determine sensitivity was 78% (45%–95%) versus 56% (27%–81%) for One-Step. From 3 weeks to 1 month Determine sensitivity was 90% (62%–98%) and One-Step 45% (21%–72%). The last negative sample occurred at 3 weeks for Determine versus 70–90 days for One-Step. HRT with p24-antigen detection significantly shortens the diagnostic window from approximatively 3 months to 1 month. HRTs should be used with caution in the first month after HIV infection.
期刊介绍:
The Journal of Medical Virology focuses on publishing original scientific papers on both basic and applied research related to viruses that affect humans. The journal publishes reports covering a wide range of topics, including the characterization, diagnosis, epidemiology, immunology, and pathogenesis of human virus infections. It also includes studies on virus morphology, genetics, replication, and interactions with host cells.
The intended readership of the journal includes virologists, microbiologists, immunologists, infectious disease specialists, diagnostic laboratory technologists, epidemiologists, hematologists, and cell biologists.
The Journal of Medical Virology is indexed and abstracted in various databases, including Abstracts in Anthropology (Sage), CABI, AgBiotech News & Information, National Agricultural Library, Biological Abstracts, Embase, Global Health, Web of Science, Veterinary Bulletin, and others.