Point of care creatinine testing for early detection of renal dysfunction in Tanzanian HIV patients: a study protocol
Abstract
Background: Renal dysfunction (RD) is more prevalent among people living with HIV (PLHIV) in sub-Saharan Africa (SSA) due to factors such as co-infections, hypertension, diabetes, and nephrotoxic antiretroviral drugs like tenofovir. Early detection of RD is critical but limited by resource constraints in many SSA countries, including Tanzania. Point-of-care (POC) tests, such as the Stat-Sensor Creatinine test by Nova Biomedical, present a cost-effective and non-invasive option for early detection. This study will evaluate the diagnostic performance of the Stat-Sensor creatinine test in detecting renal dysfunction in HIV care and treatment clinics (CTCs) in Tanzania. It will be conducted for a period of six months, from November 2024 to April 2025.
Methodology: The study will measure point-of-care creatinine using a rapid creatinine dipstick against the standard serum creatinine test. The diagnostic performance and agreement to diagnose renal dysfunction will be assessed using a standardized statistical approach: Bland-Altman analysis and linear mixed-effects models to test agreement between creatinine dipstick tests with serum creatinine. Receiver operating characteristics (ROC) statistics will be used to test the diagnostic performance of the creatinine dipstick test to diagnose renal dysfunction.
Discussion: We hypothesize that POC creatinine testing will show strong diagnostic performance, providing a reliable, rapid, and cost-efficient alternative for RD detection,…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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