Rapid HIV screening: Missed opportunities for HIV diagnosis and prevention

• Type of Material: Article
• Authors: Pragna Patel, Emory University; Berry Bennett, Florida Bureau of Laboratories; Timothy Sullivan, New York State Department of Health; Monica M. Parker, New York State Department of Health; James D. Heffelfinger, Center for Disease Control and Prevention; Patrick S Sullivan, Emory University
• Language: English
• Date: 2012-05-01
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2012.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jcv.2012.01.022
• Title of Journal or Parent Work: Journal of Clinical Virology
• ISSN: 1386-6532
• Volume: 54
• Issue: 1
• Start Page: 42
• End Page: 47
• Grant/Funding Information: This study was supported by grant 1UA1 PS000063 from the CDC.
• Keywords: Life Sciences & Biomedicine; Fourth-generation; INFECTION; HIV; Early HIV infection; Science & Technology; Virology; Acute HIV infection; PERFORMANCE; TRANSMISSION; Rapid tests; RATES
• Research Categories: Health Sciences, Epidemiology

Abstract

Background: Although rapid HIV tests increase the number of persons who are aware of their HIV status, they may fail to detect early HIV infection. Objectives: To evaluate the sensitivity for early HIV infection of several rapid tests and third- and fourth-generation assays compared with nucleic acid amplification testing (NAAT). Study design: Sensitivity for early HIV infection was evaluated using 62 NAAT-positive/WB-negative or indeterminate specimens from the CDC Acute HIV Infection study. Specimens underwent third-generation testing with Genetic Systems 1/2+O ® and rapid testing with Multispot HIV-1/HIV-2. A subset was also tested with four FDA-approved rapid tests and Determine HIV-1 Antigen/Antibody Rapid Test ® and Architect HIV Antigen/Antibody Combo ®, both fourth-generation tests. Results: Of 99,111 specimens screened from April 2006 to March 2008, 62 met the definition for early HIV infection (60 NAAT-positive/seronegative and 2 NAAT-positive/Western blot indeterminate). Third-generation testing correctly detected antibody in 34 specimens (55%; 95% confidence interval (CI): 42-67); Multispot detected antibody in 16 (26%; 95% CI: 16-38). Of the 62 specimens, 33 (53%) had sufficient quantity for further testing. Rapid test sensitivities for early HIV infection ranged from 22-33% compared with 55-57% for the third-generation assay and 76-88% for the fourth-generation tests. Conclusions: Many rapid HIV tests failed to detect half of the early HIV infection cases in whom antibody was present. Programs that screen high-incidence populations with rapid tests should consider supplemental testing with NAAT or other antigen-based tests. These data support the need for more sensitive antigen-based point-of-care screening tests for early HIV infection.