Laboratory Evaluation of the VISITECT Advanced Disease Semiquantitative Point-of-Care CD4 Test.

Autor:	Lechiile K; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Leeme TB; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Tenforde MW; Botswana-UPenn Partnership, Gaborone, Botswana., Bapabi M; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Magwenzi J; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Maithamako O; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Mulenga F; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Mohammed T; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Ngidi J; Botswana National Health Laboratory, Gaborone, Botswana., Mokomane M; University of Botswana, Gaborone, Botswana; and., Lawrence DS; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.; Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom., Mine M; Botswana National Health Laboratory, Gaborone, Botswana., Jarvis JN; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.; Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	Journal of acquired immune deficiency syndromes (1999) [J Acquir Immune Defic Syndr] 2022 Dec 15; Vol. 91 (5), pp. 502-507. Date of Electronic Publication: 2022 Sep 08.
DOI:	10.1097/QAI.0000000000003092
Abstrakt:	Background: Advanced HIV disease (AHD; CD4 counts <200 cells/µL) remains common in many low- and middle-income settings. An instrument-free point-of-care test to rapidly identify patients with AHD would facilitate implementation of the World Health Organization (WHO) recommended package of care. We performed a laboratory-based validation study to evaluate the performance of the VISITECT CD4 Advanced Disease assay in Botswana. Setting: A laboratory validation study. Methods: Venous blood samples from people living with HIV having baseline CD4 testing in Gaborone, Botswana, underwent routine testing using flow cytometry, followed by testing with the VISITECT CD4 Advanced Disease assay by a laboratory scientist blinded to the flow cytometry result with a visual read to determine whether the CD4 count was below 200 cells/µL. A second independent investigator conducted a visual read blinded to the results of flow cytometry and the initial visual read. The sensitivity and specificity of the VISITECT for detection of AHD were determined using flow cytometry as a reference standard, and interrater agreement in VISITECT visual reads assessed. Results: One thousand fifty-three samples were included in the analysis. The VISITECT test correctly identified 112/119 samples as having a CD4 count <200 cells/µL, giving a sensitivity of 94.1% (95% confidence interval: 88.3% to 97.6%) and specificity of 85.9% (95% confidence interval: 83.5% to 88.0%) compared with flow cytometry. Interrater agreement between the 2 independent readers was 97.5%, Kappa 0.92 ( P < 0.001). Conclusions: The VISITECT CD4 advanced disease reliably identified individuals with low CD4 counts and could facilitate implementation of the WHO recommended package of interventions for AHD. Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu