Evaluation of two 4th generation point-of-care assays for the detection of Human Immunodeficiency Virus infection

PLoS ONE

Volumn 12, Issue 8, 2017, Pages

  Stafylis, Chrysovalantis ^a   Klausner, Jeffrey D ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; VIRUS RNA;

ANTIBODY DETECTION; ARTICLE; BLOOD SAMPLING; DIAGNOSTIC TEST ACCURACY STUDY; DIAGNOSTIC VALUE; ENZYME IMMUNOASSAY; FROZEN SECTION; HIV RAPID TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; POINT OF CARE TESTING; RNA ANALYSIS; SENSITIVITY AND SPECIFICITY; BLOOD; FEMALE; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 2; ISOLATION AND PURIFICATION; MALE; POINT OF CARE SYSTEM; VIROLOGY;

FEMALE; HIV ANTIBODIES; HIV INFECTIONS; HIV-1; HIV-2; HUMANS; MALE; POINT-OF-CARE SYSTEMS; SENSITIVITY AND SPECIFICITY;

EID: 85028563909     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0183944     Document Type: Article

References (15)

1. Moyer VA, U.S. Preventive Services Task Force*. Screening for HIV: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013; 159(1):51–60. https://doi.org/10.7326/ 0003-4819-159-1-201307020-00645 PMID: 23698354
2. Fiebig EW, Wright DJ, Rawal BD, Garrett PE, Schumacher RT, Peddada L, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003; 17: 1871–9. PMID: 12960819
3. Smallwood M, Vijh R, Nauche B, Lebouché B, Joseph L, Pant Pai N. Evaluation of a Rapid Point of Care Test for Detecting Acute and Established HIV Infection, and Examining the Role of Study Quality on Diagnostic Accuracy: A Bayesian Meta-Analysis. PLoS One. 2016; 11(2):e0149592. https://doi.org/10.1371/journal.pone.0149592 PMID: 26891218
4. Cragin L, Pan F, Peng S, Zenilman JM, Green J, Doucet C, et al. Cost-effectiveness of a Fourth-Generation Combination Immunoassay for Human Immunodeficiency Virus (HIV) Antibody and p24 Antigen for the Detection of HIV Infections in the United States. HIV Clin Trials. 2012; 13: 11–22. https://doi.org/10.1310/hct1301-011 PMID: 22306584
5. Determine HIV–1/2 Ag/Ab Combo Package insert. 1:1–20. https://ensur.invmed.com/ensur/broker/ensurbroker.aspx?code=02732530&cs=26327664. Accessed January 1, 2016.
6. SD BIOLINE HIV Ag / Ab Combo. https://ensur.invmed.com/ensur/broker/ensurbroker.aspx?code=LEF03EN&cs=26740879. Published 2013. Accessed January 1, 2016.
7. WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: SD Bioline HIV Ag/Ab Combo Number: PQDx 0069-012-00. http://www.who.int/diagnostics_laboratory/evaluations/130322_0069_012_00_public_report_final_v1.pdf. Published 2013. Accessed October 17, 2016.
8. Chetty V, Moodley D, Chuturgoon A. Evaluation of a 4th generation rapid HIV test for earlier and reliable detection of HIV infection in pregnancy. J Clin Virol. 2012; 54(2):180–184. https://doi.org/10.1016/j.jcv.2012.02.021 PMID: 22445263
9. Faraoni S, Rocchetti A, Gotta F, Ruggiero T, Orofino G, Bonora S, et al. Evaluation of a rapid antigen and antibody combination test in acute HIV infection. J Clin Virol. Elsevier B.V.; 2013; 57: 84–87. https://doi.org/10.1016/j.jcv.2013.01.007 PMID: 23380659
10. Brauer M, De Villiers JC, Mayaphi SH. Evaluation of the Determine™ fourth generation HIV rapid assay. J Virol Methods. 2013; 189(1):180–183. https://doi.org/10.1016/j.jviromet.2013.01.017 PMID: 23391823
11. Rosenberg NE, Kamanga G, Phiri S, Nsona D, Pettifor A, Rutstein SE, et al. Detection of acute HIV infection: A field evaluation of the determine HIV-1/2 Ag/Ab combo test. J Infect Dis. Oxford University Press; 2012; 205: 528–534. https://doi.org/10.1093/infdis/jir789 PMID: 22207651
12. Fitzgerald N, Cross M, O'shea S, Fox J. Diagnosing acute HIV infection at point of care: a retrospective analysis of the sensitivity and specificity of a fourth-generation point-of-care test for detection of HIV core protein p24. Sex Transm Infect. 2016; 93:1–2. https://doi.org/10.1136/sextrans-2015-052491 PMID: 27272704
13. Fransen K, de Baetselier I, Rammutla E, Ahmed K, Owino F, Agingu W, et al. Performance of serological and molecular tests within acute HIV infection. Journal of Clinical Virology. 2016. https://doi.org/10.1016/j.jcv.2017.03.010 PMID: 28351688
14. Pandori MW, Hackett J, Louie B, Vallari A, Dowling T, Liska S, et al. Assessment of the ability of a fourth-generation immunoassay for human immunodeficiency virus (HIV) antibody and p24 antigen to detect both acute and recent HIV infections in a high-risk setting. J Clin Microbiol. American Society for Microbiology (ASM); 2009; 47: 2639–2642. https://doi.org/10.1128/JCM.00119-09 PMID: 19535523
15. Qiu X, Sokoll L, Yip P, Elliott DJ, Dua R, Mohr P, et al. Comparative evaluation of three FDA-approved HIV Ag/Ab combination tests using a genetically diverse HIV panel and diagnostic specimens. J Clin Virol. 2017; 92: 62–68. https://doi.org/10.1016/j.jcv.2017.05.005 PMID: 28535437