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

Abstract

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-µL 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.

The challenge of discriminating between HIV‐1, HIV‐2 and HIV‐1/2 dual infections

“…Chang et al . recently evaluated a new point‐of‐care molecular test for both HIV‐1 and HIV‐2 RNA quantification (Alere q HIV‐1/2 Detect; Alere Detect, Jena, Germany) and concluded that this test has potential for use in resource‐limited settings. For serological discrimination, the Geenius HIV 1/2 Supplementary Assay (Bio‐Rad, Marnes‐la‐Coquette, France ) has shown promising results , but further evaluation using samples from HIV‐1/2 dually infected patients is needed.…”

Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence

“…For the development of a TFV-specific immunoassay ( Fig. 1 illustrates a schema of immunoassay development) [17] , the UCSF Hair Analytical Laboratory (HAL), with expertise in LC/MS–MS and analyzing ARV concentrations in hair in the context of HIV treatment and prevention [18] , [19] , formed a collaboration with Alere™ Rapid Diagnostics, a company with expertise in developing POC immunoassays [20] , [21] . Scientists from the UCSF HAL and Alere™ scrutinized the molecular structure of TFV to identify unique derivatives with structural distinction from endogenous nucleotides.…”

Diagnostic tools for tackling febrile illness and enhancing patient management

“…8, [98]). It is a fully automated platform for HIV-1 and HIV-2 detection within 50 min based on real-time PCR with multiplexing capability [99,100]. It is suitable for point-of-care use due to its portable nature, battery operation, no laptop requirement, easy to use touch screen, while the cartridge can be stored at room temperature without need for cold chain.…”