Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens

Highlights • Determine Combo performs significantly better with plasma than with whole blood. • Determine Combo missed a high proportion of acute HIV-1 infections using plasma. • Determine Combo is less sensitive than an instrumented laboratory-based Ag/Ab assay.

Saved in:
Bibliographic Details
Published in:Journal of clinical virology 2017-06, Vol.91, p.95-100
Main Authors: Masciotra, Silvina, Luo, Wei, Westheimer, Emily, Cohen, Stephanie E, Gay, Cynthia L, Hall, Laura, Pan, Yi, Peters, Philip J, Owen, S. Michele
Format: Article
Language:English
Subjects:
AIDS Serodiagnosis
Allergy and Immunology
Antigen-antibody detection
HIV Antibodies - blood
HIV Antibodies - immunology
HIV Antigens - blood
HIV Antigens - immunology
HIV diagnostics
HIV Infections - diagnosis
HIV Infections - epidemiology
HIV Infections - virology
HIV Seropositivity
HIV-1 - immunology
HIV-1 - isolation & purification
HIV-2 - immunology
HIV-2 - isolation & purification
Humans
Immunoassay
Infectious Disease
Mass Screening
Plasma - virology
Prospective Studies
Rapid test
Reagent Kits, Diagnostic
United States
United States Food and Drug Administration
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Highlights • Determine Combo performs significantly better with plasma than with whole blood. • Determine Combo missed a high proportion of acute HIV-1 infections using plasma. • Determine Combo is less sensitive than an instrumented laboratory-based Ag/Ab assay.
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2017.03.019