Abstract
OBJECTIVE: HIV-1 Viral Load Testing plays a crucial role in the management of HIV/AIDS patients by quantifying the presence of HIV-1 RNA in the blood, which directly relates to viral replication and disease progression. Monitoring viral load enables healthcare professionals to evaluate the effectiveness of Anti-Retroviral Therapy, adapt treatment strategies, and assess the overall health status of individuals with HIV. This was a cross-sectional study to evaluate analytical performance (accuracy, precision and linearity) of the near point of care Xpert HIV-1 viral load. RESULTS: The analytical performance of the GeneXpert assay to the conventional Hologic Panther system was strong. Specifically, the GeneXpert demonstrated a sensitivity, specificity, and accuracy of 87.6%, 100%, and 98.5%, respectively, when compared to the Hologic Panther. A strong correlation between the two assays was evident (r = 0.97, p < 0.0001). Additionally, precision, as indicated by the coefficient of variation (CV), for high viral load was 1.38% for GeneXpert while for low viral load, it was 2.59%. In the linearity analysis, all data points remained within acceptable ranges, yielding correlation coefficients ≥ 0.99 for both assays. CONCLUSION: The Xpert HIV-1 viral load assay demonstrates high efficacy in accurately identifying and quantifying HIV-1 viral loads, making it a valuable tool for HIV diagnosis and monitoring. This reliability makes it particularly suitable for critical populations requiring timely and accurate viral load monitoring.