Detection and differentiation of HIV-2 using the point-of-care Alere q HIV-1/2 Detect nucleic acid test

作者：Chang Ming; Steinmetzer Katrin; Raugi Dana N; Smith Robert A; Ba Selly; Sall Fatima; Seydi Moussa; Niang Alassane; Sall ElHadji Ibrahima; Cisse Ousseynou; Roedel Katja; Coombs Robert W; Gottlieb Geoffrey S^*

来源：Journal of Clinical Virology, 2017, 97: 22-25.

DOI：10.1016/j.jcv.2017.10.013

• HIV-2
• Diagnosis
• Point-of-care
• Nucleic acid test
• Alere q HIV-1/2 Detect
• Qualitative

Background: The Alere q HIV-1/2 Detect test (Alere Detect) is a rapid point-of-care (POC) nucleic acid test (NAT) that can detect and differentiate HIV-1 and HIV-2 in 25-mu L whole blood or plasma samples. The Alere Detect test has been validated for early infant diagnosis of HIV-1 infection, and it is the only POC NAT device currently known to detect HIV-2, which is endemic in West Africa.
Objectives: To evaluate the sensitivity detecting HIV-2 RNA and the differential performance of the Alere Detect.
Study design: Plasma samples from non-HIV (n = 4), HIV-1 (n = 22), HIV-2 (n = 111; 29 Group A, 2 Group B) and HIV-1/HIV-2 dually-seropositive (n = 8) participants in Senegal and the United States and HIV-2 reference strains (3 Group A, 1 Group B) were tested by Alere Detect, Abbott RealTime HIV-1 and the University of Washington HIV-2 RNA quantitative (UW HIV-2) assays.
Results: The Alere Detect correctly differentiated between HIV-1 and HIV-2 in all 80 (100%) patient samples with detectable HIV RNA (n = 20 HIV-1, 60 HIV-2). The overall HIV-2 detection concordance between Alere Detect and the UW HIV-2 assay was 68% (54/80); the concordance improved to 100% (30/30) for samples with HIV-2 RNA > 300copies/mL. Neither assay detected HIV-2 RNA in 31 of 111 HIV-2 seropositive samples.
Conclusions: The Alere Detect test is a novel device detecting HIV RNA in clinical samples, and differentiating HIV-1 and HIV-2 with a high level of specificity. It has the potential for use as a rapid HIV-2 NAT-based diagnosis tool in resource-limited settings and to confirm HIV-2 infection for the CDC 4th generation HIV-1/2 diagnostic algorithm.

• 出版日期2017-12