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. 2025 Sep 11;20(9):e0331969.
doi: 10.1371/journal.pone.0331969. eCollection 2025.

Point-of-care creatinine-based eGFR (StatSensor) in detecting kidney dysfunction (KD) among people living with HIV in Tanzania

Daniel Msilanga  1   2 , Anthony Muiru  3 , Elizabeth Msangi  1   2 , Jacqueline Shoo  1   2 , Jonathan Mngumi  1   2 , Ewaldo Komba  1   2 , Emmanuel Balandya  1 , Paschal Ruggajo  4 , Rajendra Bhimma  5 , Kathleen Liu  3
Affiliations

Point-of-care creatinine-based eGFR (StatSensor) in detecting kidney dysfunction (KD) among people living with HIV in Tanzania

Daniel Msilanga et al. PLoS One. .

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. ROC curve of the StatSensor in detecting renal dysfunction.
Fig 2
Fig 2. Linear regression plot of StatSensor eGFR versus Jaffe eGFR with ±15% total allowable error limits.
Fig 3
Fig 3. Bland–Altman plot comparing StatSensor-derived eGFR to laboratory Jaffe method eGFR (mL/min/1.73m²).
See this image and copyright information in PMC

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