Performance characteristics of an instrument-free point-of-care CD4 test (VISITECT (R) CD4) for use in resource-limited settings
Vairamohan Vidhyavathi, Hussain Syed Iqbal, Kannaiyan Kanthamani, Sunil Suhas Solomon, Paneerselvam Nandagopal, Stanley Luchters, Minh D Pham, James Forbes, Suzanne M Crowe, Christopher McMurran, David A Anderson, Pachamuthu Balakrishnan
Journal of International Medical Research | SAGE PUBLICATIONS LTD | Published : 2020
OBJECTIVE: CD4+ T lymphocyte count remains the most common biomarker of immune status and disease progression in human immunodeficiency virus (HIV)-positive individuals. VISITECT®CD4 is an instrument-free, low-cost point-of-care CD4 test with a cut-off of 350 CD4 cells/μL. This study aimed to evaluate VISITECT®CD4 test's diagnostic accuracy. METHODS: Two hundred HIV-positive patients attending a tertiary HIV centre in South India were recruited. Patients provided venous blood for reference and VISITECT®CD4 tests. An additional finger-prick blood sample was obtained for VISITECT®CD4. VISITECT®CD4's diagnostic performance in identifying individuals with CD4 counts ≤350 cells/μL was assessed by..View full abstract
This study was supported by Omega Diagnostics (Asia) Pvt, Ltd., Mumbai, India. Omega Diagnostics provided the VISITECTVR CD4 tests free of charge for study purposes. The authors gratefully acknowledge the support of the Victorian Operational Infrastructure Support Program received by the Burnet Institute. Funding was provided by the National Health and Medical Research Council of Australia (NHMRC) through a Career Development Fellowship to SL.