Performance characteristics of an instrument-free point-of-care CD4 test (VISITECT®CD4) for use in resource-limited settings
| Autor: | James Forbes, Suzanne M. Crowe, Kannaiyan Kanthamani, Hussain Syed Iqbal, Paneerselvam Nandagopal, Minh D. Pham, Stanley Luchters, Vairamohan Vidhyavathi, Pachamuthu Balakrishnan, David A. Anderson, Christopher McMurran, Sunil S. Solomon |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
CD4-Positive T-Lymphocytes
medicine.medical_specialty Medicine (General) HIV monitoring assay resource-limited settings Point-of-Care Systems Point-of-care testing VISITECT®CD4 test COUNT 030231 tropical medicine Human immunodeficiency virus (HIV) India HIV Infections medicine.disease_cause Sensitivity and Specificity Biochemistry 03 medical and health sciences 0302 clinical medicine R5-920 Acquired immunodeficiency syndrome (AIDS) T-Lymphocyte Count Special Issue: Point-of-Care Testing for Sexually Transmitted Infections and Blood Borne Viruses: Opportunities and Challenges parasitic diseases Medicine and Health Sciences FINGER-PRICK BLOOD Humans Medicine 030212 general & internal medicine Intensive care medicine CD4+ count Point of care business.industry Biochemistry (medical) HIV Cell Biology General Medicine Flow Cytometry medicine.disease T-CELL ENUMERATION CD4 Lymphocyte Count Test (assessment) Biomarker (medicine) HIV/AIDS business point-of-care diagnostics Limited resources |
| Zdroj: | JOURNAL OF INTERNATIONAL MEDICAL RESEARCH Journal of International Medical Research, Vol 48 (2020) The Journal of International Medical Research |
| ISSN: | 0300-0605 1473-2300 |
| Popis: | ObjectiveCD4+ 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.MethodsTwo 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.ResultsThe 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%)].ConclusionVISITECT®CD4 performed well using venous blood, demonstrating its potential utility in decentralization of CD4 testing services in resource-constrained settings. |
| Databáze: | OpenAIRE |
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