TY  - JOUR
AU  - Vidhyavathi, V
AU  - Iqbal, HS
AU  - Kanthamani, K
AU  - Solomon, SS
AU  - Nandagopal, P
AU  - Luchters, S
AU  - Pham, MD
AU  - Forbes, J
AU  - Crowe, SM
AU  - McMurran, C
AU  - Anderson, DA
AU  - Balakrishnan, P
Y2  - 2020/11/26
Y1  - 2020/09/01
SN  - 0300-0605
UR  - http://hdl.handle.net/11343/252214
AB  - 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 calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking flow cytometry as the reference. RESULTS: The overall agreement between VISITECT®CD4 and flow cytometry was 89.5% using venous blood and 81.5% using finger-prick blood. VISITECT®CD4 showed better performance using venous blood [sensitivity: 96.6% (95% confidence interval: 92.1%-98.9%), specificity: 70.9% (57.1%-82.4%), PPV: 89.7% (83.9%-94.0%) and NPV: 88.6% (75.4%-96.2%)] than using finger-prick blood [sensitivity: 84.8% (77.9%-90.2%), specificity: 72.7% (59.0%-83.9%), PPV: 89.1% (82.7%-93.8%) and NPV: 64.5% (51.3%-76.3%)]. CONCLUSION: VISITECT®CD4 performed well using venous blood, demonstrating its potential utility in decentralization of CD4 testing services in resource-constrained settings.
LA  - English
PB  - SAGE PUBLICATIONS LTD
T1  - Performance characteristics of an instrument-free point-of-care CD4 test (VISITECT (R) CD4) for use in resource-limited settings
DO  - 10.1177/0300060520955028
IS  - Journal of International Medical Research
VL  - 48
IS  - 9
L1  - /bitstream/handle/11343/252214/0300060520955028.pdf?sequence=1&isAllowed=y
ER  -