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      Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care

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          Abstract

          Background

          Point of-care (POC) HIV-1 RNA tests which are accurate and easy to use with limited infrastructure are needed in resource-limited settings (RLS). We systematically reviewed evidence of POC test performance compared to laboratory-based HIV-1 RNA assays and the potential utility of these tests for diagnosis and care in RLS.

          Methods

          Studies published up to July 2018 were identified by a search of PUBMED, EMBASE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials. Studies evaluating the use of POC HIV-1 RNA testing for early infant diagnosis (EID), acute HIV infection (AHI) diagnosis, or viral load monitoring (VL), compared to centralized testing, were included. Separate search strategies were used for each testing objective.

          Results

          197 abstracts were screened and 34 full-text articles were assessed, of which 32 met inclusion criteria. Thirty studies evaluated performance and diagnostic accuracy of POC tests compared to standard reference tests. Two of the thirty and two additional studies with no comparative testing reported on clinical utility of POC results. Five different POC tests (Cepheid GeneXpert HIV-1 Quantitative and Qualitative assays, Alere q HIV‐1/2 Detect, SAMBA, Liat HIV Quant and Aptima HIV‐1 Quant) were used in 21 studies of VL, 11 of EID and 2 of AHI. POC tests were easy to use, had rapid turnaround times, and comparable accuracy and precision to reference technologies. Sensitivity and specificity were high for EID and AHI but lower for VL. For VL, lower sensitivity was reported for whole blood and dried blood spots compared to plasma samples. Reported error rates for Cepheid GeneXpert Qual (2.0%-5.0%), GeneXpert Quant (2.5%-17.0%) and Alere q HIV‐1/2 Detect (3.1%-11.0%) were higher than in WHO prequalification reports. Most errors resolved with retesting; however, inadequate sample volumes often precluded repeat testing. Only two studies used POC results for clinical management, one for EID and another for VL. POC EID resulted in shorter time-to-result, rapid ART initiation, and better retention in care compared to centralised testing.

          Conclusions

          Performance of POC HIV-1 RNA tests is comparable to reference assays, and have potential to improve patient outcomes. Additional studies on implementation in limited-resources settings are needed.

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          Most cited references43

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          Point-of-care nucleic acid testing for infectious diseases.

          Nucleic acid testing for infectious diseases at the point of care is beginning to enter clinical practice in developed and developing countries; especially for applications requiring fast turnaround times, and in settings where a centralized laboratory approach faces limitations. Current systems for clinical diagnostic applications are mainly PCR-based, can only be used in hospitals, and are still relatively complex and expensive. Integrating sample preparation with nucleic acid amplification and detection in a cost-effective, robust, and user-friendly format remains challenging. This review describes recent technical advances that might be able to address these limitations, with a focus on isothermal nucleic acid amplification methods. It briefly discusses selected applications related to the diagnosis and management of tuberculosis, HIV, and perinatal and nosocomial infections. Copyright © 2011. Published by Elsevier Ltd.
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            • Record: found
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            Is Open Access

            Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges

            Cost and complexity have hindered implementation to date of viral load testing in resource-limited settings. If rapid and timely scale-up is to become a reality, numerous factors will need to be addressed, including health and laboratory system strengthening, pricing, and multiple programmatic and funding challenges.
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              • Record: found
              • Abstract: found
              • Article: not found

              HIV viral load markers in clinical practice.

              Plasma HIV RNA determinations are an important prognostic marker of disease progression and, when used appropriately, provide a valuable tool for the management of individual patients. But what constitutes appropriate use?
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: Data curation
                Role: Writing – review & editing
                Role: Writing – review & editing
                Role: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                27 June 2019
                2019
                : 14
                : 6
                : e0218369
                Affiliations
                [1 ] Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya
                [2 ] International AIDS Vaccine Initiative (IAVI), Department of Medical Affairs, New York, New York, United States of America
                [3 ] Department of Global Health, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands
                [4 ] School of Medicine, College of Health Sciences, University of Nairobi, Nairobi, Kenya
                [5 ] Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
                [6 ] Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington, United States of America
                University of Ghana College of Health Sciences, GHANA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0003-1053-4463
                http://orcid.org/0000-0001-7847-8686
                Article
                PONE-D-18-31388
                10.1371/journal.pone.0218369
                6597060
                31246963
                a1f59d17-aeba-44e0-be24-649c4e6eb870
                © 2019 Agutu et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 8 November 2018
                : 31 May 2019
                Page count
                Figures: 3, Tables: 3, Pages: 25
                Funding
                This work was supported through the Sub-Saharan African Network for TB/HIV Research Excellence (SANTHE), a DELTAS Africa Initiative [grant # DEL-15-006]. The DELTAS Africa Initiative is an independent funding scheme of the African Academy of Sciences (AAS)’s Alliance for Accelerating Excellence in Science in Africa (AESA) and supported by the New Partnership for Africa’s Development Planning and Coordinating Agency (NEPAD Agency) with funding from the Wellcome Trust [grant # 107752/Z/15/Z] and the UK government. SMG was supported by the Robert W. Anderson Endowed Professorship in Medicine. The views expressed in this publication are those of the authors and not necessarily those of AAS, NEPAD Agency, Wellcome Trust or the UK government’. This manuscript was submitted for publication with the permission from the Director of the Kenya Medical Research Institute (KEMRI).
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                The data underlying the results presented in the study are available from publicly accessible peer reviewed publications. The search terms and databases used to generate said publications have been provided as supplementary material.

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