Msilanga Daniel, Muiru Anthony, Msangi Elizabeth, Shoo Jacqueline, Mngumi Jonathan, Komba Ewaldo, Balandya Emmanuel, Ruggajo Paschal, Bhimma Rajendra, Liu Kathleen
Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Muhimbili National Hospital, Tanzania.
PLoS One. 2025 Sep 11;20(9):e0331969. doi: 10.1371/journal.pone.0331969. eCollection 2025.
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.
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.
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.
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.
在低收入和中等收入国家（LMICs），肾功能不全（KD）在艾滋病毒感染者（PLHIV）中普遍存在，但由于实验室基础设施不足，常规筛查受到限制。StatSensor®即时检验（POC）肌酐检测为早期KD检测提供了一种快速、经济高效的替代方法，但其在PLHIV中的准确性仍不确定。
2025年1月至3月，我们在特梅克地区转诊医院（TRRH）的艾滋病毒诊所对年龄≥18岁的PLHIV进行了一项诊断准确性横断面研究。肾功能不全（KD）定义为使用CKD-EPI 2021方程估计的肾小球滤过率（eGFR）<60 mL/min/1.73 m²。我们将StatSensor即时检验eGFR结果与通过Jaffe法测量的血清肌酐得出的eGFR进行了比较。报告了诊断性能指标，包括敏感性、特异性、预测值和受试者工作特征（ROC）曲线。
在358名参与者中，中位年龄为48岁，女性占66.2%，15.6%患有KD（eGFR<60 mL/min/1.73m²）。与Jaffe法相比，StatSensor的敏感性为92.9%，特异性为94.7%，总体诊断准确性为94.4%。ROC曲线（AUC = 0.938）表明检测性能良好，kappa值为0.805，显示出高度一致性。Bland-Altman分析显示，偏差为-4.36 mL/min/1.73 m²，一致性界限为-19.68至28.40，两种方法之间具有强相关性（R² = 0.813）。
StatSensor即时检验肌酐检测显示出较高的诊断准确性，与标准Jaffe法高度一致，表明其在资源有限环境中作为PLHIV肾功能不全可靠筛查工具的潜力。
