Evaluation of the Diagnostic Validity of the HIV VISITECT CD4 Point-of-Care Rapid Diagnostic Test Using PIMA Analyzer as the Gold Standard in Uganda.

Abstract

Background: HIV remains prevalent in Uganda, and the cluster of differentiation-4 (CD4) markers are widely used to support and monitor disease progression. Objectives: This study aimed to compare the diagnostic validity of the VISITECT CD4 LFA with instrument-based POC tests (Pima Analyzer) for CD4 measurement and to explore the factors influencing its performance in the Ugandan setting. Methods: A laboratory-based comparative study was conducted from 1 st June 2023 to 30 th August 2023. A total of three hundred fifty (351) subjects were enrolled into this study; majority females 238/351 (68%), and median age was 31 years (IQR 25 - 38). The Mean CD4 count using PIMA was 482 cells (±283.9 cells/µl). Results: The sensitivity of VISITECT CD4 LFA was 86.25 % and Specificity 90.41%. The positive and negative predictive values were 72.63% and 95.70% respectively. Conclusions: Based on diagnostic performance characteristics, VISITECT CD4 LFA is a reliable tool for guiding timely Advanced HIV Disease (AHD) screening among individuals with HIV/AIDS especially in resource limited setting. Focus should be on refining the test's accuracy and reducing the observed discrepancies in sensitivity and specificity, ultimately contributing to more precise and timely AHD screening for individuals living with HIV/AIDS.