Abstract
INTRODUCTION: Kidney Dysfunction (KD) is prevalent among people living with HIV (PLHIV) in low- and middle-income countries (LMICs), but routine screening is limited due to inadequate laboratory infrastructure. The StatSensor® Point-of-Care (POC) Creatinine Test offers a rapid, cost-effective alternative for early KD detection, though its accuracy in PLHIV remains uncertain. METHODS: We conducted a diagnostic accuracy cross-sectional study at Temeke Regional Referral Hospital (TRRH) HIV Clinic from January to March 2025 among PLHIV aged ≥18 years. Kidney dysfunction (KD) was defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² using the CKD-EPI 2021 equation. We compared StatSensor point-of-care eGFR results with eGFR derived from serum creatinine measured by the Jaffe method. Diagnostic performance metrics including sensitivity, specificity, predictive values, and receiver operating characteristic (ROC) curves were reported. RESULTS: Among 358 participants, the median age was 48 years, with 66.2% female and 15.6% having KD (eGFR < 60 mL/min/1.73m²). The StatSensor demonstrated 92.9% sensitivity, 94.7% specificity, and 94.4% overall diagnostic accuracy compared to the Jaffe method. The ROC curve (AUC = 0.938) indicated strong test performance, showing substantial agreement with a kappa value of 0.805. Bland-Altman analysis revealed a negative bias of 4.36 mL/min/1.73 m² with limits of agreement from -19.68 to 28.40 and a strong correlation (R² = 0.813) between the two methods. CONCLUSION: The StatSensor POC Creatinine test demonstrated high diagnostic accuracy and strong agreement with the standard Jaffe method, indicating its potential as a reliable screening tool for kidney dysfunction in PLHIV in resource-limited settings.