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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-?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.

SUBMITTER: Chang M

PROVIDER: S-EPMC5700839 | biostudies-other | 2017 Dec

REPOSITORIES: biostudies-other

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

Chang Ming M Steinmetzer Katrin K Raugi Dana N DN Smith Robert A RA Ba Selly S Sall Fatima F Seydi Moussa M Niang Alassane A Sall ElHadji Ibrahima EI Cisse Ousseynou O Rödel Katja K Coombs Robert W RW Gottlieb Geoffrey S GS

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 20171024

<h4>Background</h4>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.<h4>Objectives</h4>To evaluate the sensitivity detecting HIV-2 RNA and the differential performance of ...[more]

PMID: 29096389

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Project description:AimsTo evaluate provider perspectives on the use of a point-of-care nucleic acid test (POC NAT) and preferential opinions for motivational interviewing (MI) or problem-solving counseling (PSC) as an ultra-brief intervention for patients experiencing challenges to antiretroviral therapy (ART) adherence.MethodsA qualitative study was conducted among providers at an HIV care clinic in Seattle, Washington. Ten in-depth interviews with HIV care providers were completed, which explored determinants of acceptability, feasibility and preferences for a combined adherence counseling and POC NAT intervention for patients living with HIV. Interviews were analyzed through consensus coding and the Five A's Framework to inform thematic analysis.ResultsProviders favored the use of a combined adherence counseling technique and POC NAT for their non-adherent patients living with HIV. Providers believed the intervention was an improvement on current assessment and advising practices. However, concerns about extended wait times for the POC NAT results influenced perceptions about feasibility around clinic flow and incorporation into clinic practice. Providers believed that acceptability of POC NAT implementation would be enhanced by including a subset of patient populations whom tend to be in the clinic for longer periods, and in tandem face greater ART adherence challenges.ConclusionThe GAIN Study will be the first project to evaluate the implementation of POC NAT in the U.S. Continued formative work is ongoing and may illustrate how best to address feasibility and concern around the two-hour time to result. The planned GAIN study will incorporate some of the findings found in this qualitative study and pilot this intervention, including a time-in-motion analyses of clinic flow, which may help reduce perceived wide-scale adaptation of POC NAT and ART adherence counselling among PLHW. Future work, including a shorter time to results and/or lower limit detection could make a significant improvement in the provision of HIV care.

Project description:BackgroundResource-limited regions face a greater burden of infectious diseases due to limited access to molecular tests, complicating timely diagnosis and management. Current molecular point-of-care tests (POCTs) either come with high costs or lack adequate sensitivity and specificity. To facilitate better prevention and control of infectious diseases in underserved areas, we seek to address the need for molecular POCTs that better align with the World Health Organization (WHO)'s ASSURED criteria-Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free, and Deliverable to end users.MethodsA novel molecular POCT, Pasteur Pipette-assisted isothermal probe amplification (pp-IPA), was developed for malaria detection. Without any microfluidics, this method captures Plasmodium 18S rRNA in a modified Pasteur pipette using tailed genus-specific probes. After washing, the bound tailed probes are ligated to form a template for subsequent novel isothermal probe amplification using a pair of generic primers, bypassing nucleic acid extraction and reverse transcription. The method was assessed using cultured Plasmodium and compared with real-time quantitative reverse transcription PCR (RT-qPCR) or reverse transcription loop-mediated isothermal amplification (RT-LAMP) in clinical blood samples.ResultsThe entire assay is completed in 60-80 min with minimal hands-on time, using only a Pasteur pipette and a water bath. The pp-IPA's analytical sensitivity is 1.28 × 10-4 parasites/μl, with 100% specificity against various blood-borne pathogens causing malaria-like symptoms. Additionally, pp-IPA needs only liquid-transfer skill for operation and the cost is around USD 0.25 per test, making it at least 300 times lower than mainstream POCT platforms.ConclusionsDesigned to improve the accessibility of molecular detection in resource-limited settings, pp-IPA's simplicity, affordability, high sensitivity/specificity, and minimal equipment requirements make it a promising point-of-care pathogen identification tool in resource-constrained regions.

Dataset Information

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

Publications

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

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