A prospective evaluation of the diagnostic accuracy of the point-of-care VISITECT CD4 Advanced Disease test in seven countries.

Autor:	Gils T; Department of Clinical Sciences, Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium.; Global Health Institute, University of Antwerp, Doornstraat 331, 2610 Wilrijk, Belgium., Hella J; Ifakara Health Institute, Dar es Salaam, Tanzania., Jacobs BKM; Department of Clinical Sciences, Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium., Sossen B; Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.; Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Mukoka M; Public Health Group, Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi.; Department of Pathology, Kamuzu University of Health Sciences, Blantyre, Malawi., Muyoyeta M; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia., Nakabugo E; Infectious Diseases Institute, Makerere University, Kampala, Uganda., Van Nguyen H; National Lung Hospital, Ha Noi, Viet Nam., Ubolyam S; HIV-NAT, Thai Red Cross AIDS Research Centre and Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand., Macé A; FIND, the global alliance for diagnostics, Geneva, Switzerland., Vermeulen M; Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Nyangu S; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia., Sanjase N; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia., Sasamalo M; Ifakara Health Institute, Dar es Salaam, Tanzania., Dinh HT; National Lung Hospital, Ha Noi, Viet Nam., Ngo TA; Viet Tiep Hospital, Hai Phong, Viet Nam., Manosuthi W; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand., Jirajariyavej S; Taksin Hospital, Bangkok, Thailand., Denkinger CM; FIND, the global alliance for diagnostics, Geneva, Switzerland.; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg, Germany.; German Centre for Infection Research (DZIF), Partner site Heidelberg University Hospital, Heidelberg, Germany., Nguyen NV; National Lung Hospital, Ha Noi, Viet Nam., Avihingsanon A; HIV-NAT, Thai Red Cross AIDS Research Centre and Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand., Nakiyingi L; Infectious Diseases Institute, Makerere University, Kampala, Uganda., Székely R; FIND, the global alliance for diagnostics, Geneva, Switzerland., Kerkhoff AD; Division of HIV, Infectious Diseases and Global Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California San Francisco, San Francisco, CA, United States of America., MacPherson P; Public Health Group, Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi.; School of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.; Clinical Research Department, London School of Hygiene & Tropical Medicine, London, United Kingdom., Meintjes G; Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.; Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Reither K; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland., Ruhwald M; FIND, the global alliance for diagnostics, Geneva, Switzerland.
Jazyk:	angličtina
Zdroj:	The Journal of infectious diseases [J Infect Dis] 2024 Jul 24. Date of Electronic Publication: 2024 Jul 24.
DOI:	10.1093/infdis/jiae374
Abstrakt:	Background: CD4 measurement is pivotal in the management of advanced HIV disease. VISITECT® CD4 Advanced Disease (AccuBio Limited, Alva, UK; VISITECT) is an instrument-free, point-of-care, semi-quantitative test allowing visual identification of a CD4 ≤200 cells/µl, or >200 cells/µl from finger-prick or venous blood. Methods: As part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM (clinicaltrials.gov: NCT04089423), people living with HIV of ≥18 years old were prospectively recruited in seven countries from outpatient departments if a tuberculosis symptom was present, and from inpatient departments. Participants provided venous blood for CD4 measurement using flow cytometry (reference standard) and finger-prick blood for VISITECT (index text), performed at point-of-care. Sensitivity, specificity, and positive and negative predictive values of VISITECT to determine a CD4 ≤200 cells/µl were evaluated. Results: Among 1604 participants, the median flow cytometry CD4 was 367 (IQR 128-626) cells/µl and 521 (32.5%) had a CD4 ≤200 cells/µl. VISITECT sensitivity was 92.7% (483/521, 95% CI 90.1-94.7%) and specificity was 61.4% (665/1083, 95% CI 58.4-64.3%). For participants with a CD4 between 0-100, 101-200, 201-300, 301-500, and >500 cells/µl, VISITECT misclassified 4.5% (95% CI 2.5-7.2%), 12.5 (95% CI 8.0-18.2%), 74.1% (95% CI 67.0-80.5%), 48.0% (95% CI 42.5-53.6%), and 22.6% (95% CI 19.3-26.3%), respectively. Conclusions: VISITECT's sensitivity, but not specificity, met the World Health Organization's minimal sensitivity and specificity threshold of 80% for point-of-care CD4 tests. VISITECT's quality needs to be assessed and its accuracy optimized. VISITECT´s utility as CD4 triage test should be investigated. (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze:	MEDLINE
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