title: Determination of HIV Status in African Adults With Discordant HIV Rapid Tests.
abstract: BACKGROUND
  In resource-limited settings, HIV infection is often diagnosed using 2 rapid tests. If the results are discordant, a third tie-breaker test is often used to determine HIV status. This study characterized samples with discordant rapid tests and compared different testing strategies for determining HIV status in these cases.
  
  
  METHODS
  Samples were previously collected from 173 African adults in a population-based survey who had discordant rapid test results. Samples were classified as HIV positive or HIV negative using a rigorous testing algorithm that included two fourth-generation tests, a discriminatory test, and 2 HIV RNA tests. Tie-breaker tests were evaluated, including rapid tests (1 performed in-country), a third-generation enzyme immunoassay, and two fourth-generation tests. Selected samples were further characterized using additional assays.
  
  
  RESULTS
  Twenty-nine samples (16.8%) were classified as HIV positive and 24 of those samples (82.8%) had undetectable HIV RNA. Antiretroviral drugs were detected in 1 sample. Sensitivity was 8.3%-43% for the rapid tests; 24.1% for the third-generation enzyme immunoassay; 95.8% and 96.6% for the fourth-generation tests. Specificity was lower for the fourth-generation tests than the other tests. Accuracy ranged from 79.5% to 91.3%.
  
  
  CONCLUSIONS
  In this population-based survey, most HIV-infected adults with discordant rapid tests were virally suppressed without antiretroviral drugs. Use of individual assays as tie-breaker tests was not a reliable method for determining HIV status in these individuals. More extensive testing algorithms that use a fourth-generation screening test with a discriminatory test and HIV RNA test are preferable for determining HIV status in these cases.
authors.affiliation: *Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; †Program in Global Health, University of California, Los Angeles, Los Angeles, CA; ‡Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; §Department of Global Health, University of Washington, Seattle, WA; ‖Department of Probability and Statistics, Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic; ¶Muhimbili University of Health and Allied Sciences, Muhimbili University Teaching Hospital, Dar es Salaam, Tanzania; #DST-NRF Centre of Excellence in Human Development, Universities of the Witwatersrand and KwaZulu-Natal, Johannesburg, South Africa; **Human Sciences Research Council, Durban, South Africa; ††Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, University of the Witwatersrand, Johannesburg, South Africa; ‡‡South African Medical Research Council, Cape Town, South Africa; §§Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC; and ‖‖Center for World Health, David Geffen School of Medicine and UCLA Health, Los Angeles, CA.
authors.forename: Jessica M
authors.initials: JM
authors.lastname: Fogel
authors.forename: Estelle
authors.initials: E
authors.lastname: Piwowar-Manning
authors.forename: Kelsey
authors.initials: K
authors.lastname: Donohue
authors.forename: Vanessa
authors.initials: V
authors.lastname: Cummings
authors.forename: Mark A
authors.initials: MA
authors.lastname: Marzinke
authors.forename: William
authors.initials: W
authors.lastname: Clarke
authors.forename: Autumn
authors.initials: A
authors.lastname: Breaud
authors.forename: Agnès
authors.initials: A
authors.lastname: Fiamma
authors.forename: Deborah
authors.initials: D
authors.lastname: Donnell
authors.forename: Michal
authors.initials: M
authors.lastname: Kulich
authors.forename: Jessie K K
authors.initials: JK
authors.lastname: Mbwambo
authors.forename: Linda
authors.initials: L
authors.lastname: Richter
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
authors.forename: Michael
authors.initials: M
authors.lastname: Sweat
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Coates
authors.forename: Susan H
authors.initials: SH
authors.lastname: Eshleman
mesh_terms: D000328:Adult; D015483:HIV Antibodies / Q000097:blood; D015488:HIV Antigens / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards*; D012680:Sensitivity and Specificity; D013019:South Africa / Q000453:epidemiology; D013636:Tanzania / Q000453:epidemiology; D013997:Time Factors
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens
references.citation: PLoS One. 2013;8(7):e68349
references.pmid: 23874597
references.citation: Clin Infect Dis. 2014 Jan;58(1):117-20
references.pmid: 24092804
references.citation: J Clin Virol. 2014 Mar;59(3):172-6
references.pmid: 24440176
references.citation: J Acquir Immune Defic Syndr. 2014 Apr 1;65(4):390-6
references.pmid: 24583613
references.citation: Expert Rev Anti Infect Ther. 2014 Jan;12(1):49-62
references.pmid: 24404993
references.citation: HIV Clin Trials. 2014 Mar-Apr;15(2):62-8
references.pmid: 24710920
references.citation: Clin Chim Acta. 2014 Jun 10;433:157-68
references.pmid: 24661980
references.citation: AIDS. 2014 May 15;28(8):1227-32
references.pmid: 24513567
references.citation: Lancet Glob Health. 2014 May;2(5):e267-77
references.pmid: 25103167
references.citation: Cell Host Microbe. 2014 Aug 13;16(2):215-26
references.pmid: 25121750
references.citation: J Acquir Immune Defic Syndr. 2014 Dec 1;67(4):405-8
references.pmid: 25140905
references.citation: J Infect Dis. 2009 Dec 1;200(11):1714-23
references.pmid: 19852669
references.citation: J Acquir Immune Defic Syndr. 2008 Jun 1;48(2):211-5
references.pmid: 18520680
references.citation: AIDS Res Hum Retroviruses. 2008 Jul;24(7):941-6
references.pmid: 18593340
references.citation: J Virol. 2009 Jan;83(1):329-35
references.pmid: 18945778
references.citation: AIDS. 2011 Mar 13;25(5):679-89
references.pmid: 21297424
references.citation: Clin Infect Dis. 2009 Sep 15;49(6):982-6
references.pmid: 19681706
references.citation: J Clin Microbiol. 2001 May;39(5):1808-12
references.pmid: 11325995
references.citation: AIDS. 2003 Sep 5;17(13):1871-9
references.pmid: 12960819
references.citation: J Clin Microbiol. 1999 Aug;37(8):2557-63
references.pmid: 10405401
references.citation: Clin Diagn Lab Immunol. 2005 Jul;12(7):855-60
references.pmid: 16002635
references.citation: Clin Infect Dis. 2005 Oct 1;41(7):1053-6
references.pmid: 16142675
references.citation: J Clin Virol. 2006 Sep;37(1):68-71
references.pmid: 16875874
references.citation: J Infect Dis. 2007 Feb 1;195(3):416-24
references.pmid: 17205481
references.citation: AIDS. 2007 Oct 18;21(16):2237-42
references.pmid: 18090052
references.citation: J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):496-9
references.pmid: 20306555
references.citation: J Clin Microbiol. 2010 May;48(5):1570-7
references.pmid: 20181896
references.citation: HIV Med. 2011 Jan;12(1):46-53
references.pmid: 20553336
references.citation: J Int AIDS Soc. 2011;14:18
references.pmid: 21477317
references.citation: N Engl J Med. 2011 Aug 11;365(6):493-505
references.pmid: 21767103
references.citation: Curr Opin HIV AIDS. 2013 Jan;8(1):12-8
references.pmid: 23188179
references.citation: Sex Transm Infect. 2013 Mar;89(2):120-1
references.pmid: 23408314
references.citation: PLoS One. 2013;8(2):e55525
references.pmid: 23437058
references.citation: MMWR Morb Mortal Wkly Rep. 2013 Jun 21;62(24):489-94
references.pmid: 23784012
references.citation: Nat Rev Immunol. 2013 Jul;13(7):487-98
references.pmid: 23797064
references.citation: AIDS Res Hum Retroviruses. 2013 Aug;29(8):1146-50
references.pmid: 23641870