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      Field Performance and Diagnostic Accuracy of a Low-Cost Instrument-Free Point-of-Care CD4 Test (Visitect CD4) Performed by Different Health Worker Cadres among Pregnant Women

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          Abstract

          Measuring CD4 counts remains an important component of HIV care. The Visitect CD4 is the first instrument-free low-cost point-of-care CD4 test with results interpreted visually after 40 min, providing a result of ≥350 CD4 cells/mm 3.

          ABSTRACT

          Measuring CD4 counts remains an important component of HIV care. The Visitect CD4 is the first instrument-free low-cost point-of-care CD4 test with results interpreted visually after 40 min, providing a result of ≥350 CD4 cells/mm 3. The field performance and diagnostic accuracy of the test was assessed among HIV-infected pregnant women in South Africa. A nurse performed testing at the point-of-care using both venous and finger-prick blood, and a counselor and laboratory staff tested venous blood in the clinic laboratory (four Visitect CD4 tests/participant). Performance was compared to the mean CD4 count from duplicate flow cytometry tests on venous blood (FACSCalibur Trucount). In 2017, 156 patients were enrolled, providing a total of 624 Visitect CD4 tests (468 venous and 156 finger-prick samples). Of 624 tests, 28 (4.5%) were inconclusive. Generalized linear mixed modeling showed better performance of the test on venous blood (sensitivity = 81.7%; 95% confidence interval [CI] = 72.3 to 91.1]; specificity = 82.6%, 95% CI = 77.1 to 88.1) than on finger-prick specimens (sensitivity = 60.7%; 95% CI = 45.0 to 76.3; specificity = 89.5%, 95% CI = 83.2 to 95.8; P = 0.001). No difference in performance was detected by cadre of health worker ( P = 0.113) or between point-of-care versus laboratory-based testing ( P = 0.108). Adequate performance of Visitect CD4 with different operators and at the point of care, with no need of electricity or instrument, shows the potential utility of this device, especially for facilitating decentralization of CD4 testing services in rural areas.

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          Persistent High Burden of Advanced HIV Disease Among Patients Seeking Care in South Africa’s National HIV Program: Data From a Nationwide Laboratory Cohort

          Abstract Background The South African national HIV program has increased antiretroviral therapy (ART) coverage over the last decade, supported by policy changes allowing for earlier ART initiation. However, many patients still enter care with advanced (<200 cells/μL) and very advanced (<100 cells/μL) HIV disease. We assessed disease progression at entry to care using nationwide laboratory data. Methods We constructed a national HIV cohort using laboratory records containing HIV RNA loads and CD4 counts from 2004 to 2016 to determine entry into care. We estimated numbers and proportions of adults with the first CD4 count <100 cells/ μL or 100–199 cells/μL. We calculated relative risks of presenting with advanced disease associated with male sex. Results 8.04 million first CD4 results were identified. From 2005 to 2011, the proportion of patients entering into care with CD4 count <200 cells/μL declined from 46.8% to 35.6%. From 2011 onward, the proportion of patients entering ART with advanced HIV disease has remained relatively unchanged. In 2016, we estimated that of 654 868 patients entering care, 32.9% had advanced HIV disease, and 16.8% had very advanced HIV disease. Men were almost twice as likely as women (23.1% vs 12.6% ) to enter care with very advanced HIV disease. Conclusions The proportion of patients presenting with advanced HIV disease in South Africa remains consistently high despite ART scale-up, representing a large and avoidable burden of morbidity. Early HIV diagnosis, rapid linkage to ART and approaches to attract men into early ART initiation should be prioritized.
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            Measurement error proportional to the mean.

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              The evolving role of CD4 cell counts in HIV care.

              The role of the CD4 cell count in the management of people living with HIV is once again changing, most notably with a shift away from using CD4 assays to decide when to start antiretroviral therapy (ART). This article reflects on the past, current and future role of CD4 cell count testing in HIV programmes, and the implications for clinicians, programme managers and diagnostics manufacturers.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                J Clin Microbiol
                J. Clin. Microbiol
                jcm
                jcm
                JCM
                Journal of Clinical Microbiology
                American Society for Microbiology (1752 N St., N.W., Washington, DC )
                0095-1137
                1098-660X
                21 November 2018
                30 January 2019
                February 2019
                30 January 2019
                : 57
                : 2
                : e01277-18
                Affiliations
                [a ]Burnet Institute, Melbourne, Victoria, Australia
                [b ]Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
                [c ]International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium
                [d ]Empilweni Services and Research Unit, Department of Paediatrics & Child Health, Rahima Moosa Mother and Child Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
                [e ]Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
                [f ]Omega Diagnostics, Ltd., Omega House, Alva, Scotland
                [g ]The Alfred Hospital and Department of Infectious Diseases, Monash University, Melbourne, Victoria, Australia
                Rhode Island Hospital
                Author notes
                Address correspondence to Stanley Luchters, Stanley.luchters@ 123456burnet.edu.au .

                Citation Luchters S, Technau K, Mohamed Y, Chersich MF, Agius PA, Pham MD, Garcia ML, Forbes J, Shepherd A, Coovadia A, Crowe SM, Anderson DA. 2019. Field performance and diagnostic accuracy of a low-cost instrument-free point-of-care CD4 test (Visitect CD4) performed by different health worker cadres among pregnant women. J Clin Microbiol 57:e01277-18. https://doi.org/10.1128/JCM.01277-18.

                Article
                01277-18
                10.1128/JCM.01277-18
                6355532
                30463898
                865da88d-423b-4ff9-aaf6-a576cb1222d0
                Copyright © 2019 Luchters et al.

                This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

                History
                : 8 August 2018
                : 23 August 2018
                : 12 November 2018
                Page count
                Figures: 4, Tables: 2, Equations: 2, References: 31, Pages: 12, Words: 7105
                Funding
                Funded by: Saving Lives at Birth Partners;
                Award ID: AID-OAA-F-13-00011
                Award Recipient : Award Recipient : Award Recipient : Award Recipient : Award Recipient : Award Recipient : Award Recipient : Award Recipient :
                Funded by: Victorian Infrastructural Support Programme;
                Award Recipient : Award Recipient : Award Recipient : Award Recipient : Award Recipient : Award Recipient : Award Recipient :
                Funded by: Department of Health | National Health and Medical Research Council (NHMRC), https://doi.org/10.13039/501100000925;
                Award ID: GNT1063725
                Award ID: GNT1090805
                Award Recipient : Award Recipient : Award Recipient : Award Recipient :
                Categories
                Immunoassays
                Custom metadata
                February 2019

                Microbiology & Virology
                cd4 count,field performance,hiv,south africa,diagnostic accuracy,point-of-care diagnostics,sensitivity,specificity,task shifting

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