-
Tytuł:
-
An HIV Diagnostic Testing Algorithm Using the cobas HIV-1/HIV-2 Qualitative Assay for HIV Type Differentiation and Confirmation.
-
Autorzy:
-
Duncan D; Roche Molecular Systems, Pleasanton, California, USA.
Duncan J; Roche Molecular Systems, Pleasanton, California, USA.
Kramer B; Roche Molecular Systems, Basel, Switzerland.
Nilsson AY; Roche Molecular Systems, Basel, Switzerland.
Haile B; Roche Molecular Systems, Pleasanton, California, USA.
Butcher A; Roche Molecular Systems, Pleasanton, California, USA.
Chugh S; Roche Molecular Systems, Pleasanton, California, USA.
Baum P; Roche Molecular Systems, Pleasanton, California, USA.
Aldrovandi GM; Department of Pediatrics, University of California, Los Angeles, Los Angeles, California, USA.
Young S; TriCore Reference Laboratories, Albuquerque, New Mexico, USA.
Avery AK; MetroHealth, Cleveland, Ohio, USA.
Tashima K; The Miriam Hospital, Providence, Rhode Island, USA.
Valsamakis A; Roche Molecular Systems, Pleasanton, California, USA.
Yao JD; Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Chang M; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA.
Coombs RW; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA.; Department of Medicine, University of Washington, Seattle, Washington, USA.
-
Źródło:
-
Journal of clinical microbiology [J Clin Microbiol] 2021 Jun 18; Vol. 59 (7), pp. e0303020. Date of Electronic Publication: 2021 Jun 18.
-
Typ publikacji:
-
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
-
Język:
-
English
-
Imprint Name(s):
-
Original Publication: Washington, American Society for Microbiology.
-
MeSH Terms:
-
HIV Infections*/diagnosis
HIV-1*/genetics
Algorithms ; Diagnostic Tests, Routine ; HIV-2/genetics ; Humans ; RNA, Viral ; Sensitivity and Specificity
-
References:
-
J Clin Virol. 2014 Aug;60(4):399-401. (PMID: 24932737)
Lancet HIV. 2018 Jul;5(7):e390-e399. (PMID: 30052509)
J Clin Microbiol. 1997 Nov;35(11):2886-93. (PMID: 9350753)
Curr Opin HIV AIDS. 2011 May;6(3):163-8. (PMID: 21502920)
HIV Med. 2007 Sep;8(6):396-400. (PMID: 17661848)
AIDS. 2017 Sep 10;31(14):2007-2016. (PMID: 28692542)
J Clin Microbiol. 2019 May 24;57(6):. (PMID: 30944187)
Sex Transm Dis. 2020 May;47(5S Suppl 1):S18-S25. (PMID: 31895304)
Clin Infect Dis. 2011 Mar 15;52(6):780-7. (PMID: 21367732)
J Clin Virol. 2019 Feb;111:24-28. (PMID: 30594702)
J Clin Microbiol. 2011 Sep;49(9):3163-7. (PMID: 21752974)
J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):547-555. (PMID: 28914669)
Sex Transm Dis. 2020 May;47(5S Suppl 1):S26-S31. (PMID: 31977972)
Vaccine. 2015 Mar 3;33(10):1243-9. (PMID: 25649349)
J Clin Virol. 2012 Oct;55(2):128-33. (PMID: 22832059)
Antivir Ther. 2004 Feb;9(1):3-12. (PMID: 15040531)
Int J STD AIDS. 2014 Sep;25(10):695-704. (PMID: 24759563)
HIV Med. 2008 Oct;9(9):790-3. (PMID: 18754803)
Sex Transm Dis. 2020 May;47(5S Suppl 1):S13-S17. (PMID: 32343517)
MMWR Morb Mortal Wkly Rep. 2020 Jan 24;69(3):63-66. (PMID: 31971928)
Clin Vaccine Immunol. 2014 Aug;21(8):1192-4. (PMID: 24943380)
-
Grant Information:
-
UM1 AI069412 United States AI NIAID NIH HHS; UM1 AI068618 United States AI NIAID NIH HHS; P30 AI042853 United States AI NIAID NIH HHS; P30 AI027757 United States AI NIAID NIH HHS; UM1 AI106701 United States AI NIAID NIH HHS
-
Contributed Indexing:
-
Keywords: HIV-1; HIV-2; PCR; diagnosis; testing algorithm
-
Substance Nomenclature:
-
0 (RNA, Viral)
-
Entry Date(s):
-
Date Created: 20210415 Date Completed: 20210628 Latest Revision: 20211219
-
Update Code:
-
20240104
-
PubMed Central ID:
-
PMC8218759
-
DOI:
-
10.1128/JCM.03030-20
-
PMID:
-
33853869
-
Human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) diagnostic testing algorithms recommended by the Centers for Disease Control involve up to three tests and rely mostly on detection of viral antigen and host antibody responses. HIV-1 p24 antigen/HIV-1/HIV-2 antibody-reactive specimens are confirmed with an immunochromatographic HIV-1/HIV-2 antibody differentiation assay, and negative or indeterminate results from the differentiation assay are resolved by an HIV-1-specific nucleic acid amplification test (NAT). The performance of a proposed alternative algorithm using the cobas HIV-1/HIV-2 qualitative NAT as the differentiation assay was evaluated in subjects known to be infected with HIV-1 ( n = 876) or HIV-2 ( n = 139), at low ( n = 6,017) or high ( n = 1,020) risk of HIV-1 infection, or at high-risk for HIV-2 infection ( n = 498) (study A). The performance of the cobas HIV-1/HIV-2 qualitative test was also evaluated by comparison to an HIV-1 or HIV-2 alternative NAT (study B). The HIV-1 and HIV-2 overall percent agreements (OPA) in study A ranged from 95% to 100% in all groups. The positive percent agreements (PPA) for HIV-1 and HIV-2 were 100% (876/876) and 99.4% (167/168), respectively, for known positive groups. The negative percent agreement in the HIV low-risk group was 100% for both HIV-1 and HIV-2. In study B, the HIV-1 and HIV-2 OPA ranged from 99% to 100% in all groups evaluated ( n = 183 to 1,030), and the PPA for HIV-1 and HIV-2 were 100% and 99.5%, respectively, for known positive groups. The cobas HIV-1/HIV-2 qualitative assay can discriminate between HIV-1 and HIV-2 based on HIV RNA and can be included in an alternative diagnostic algorithm for HIV.
