Abstract
OBJECTIVES: The determination of urinary albumin, crucial for chronic kidney disease (CKD) diagnosis and monitoring, typically employs quantitative techniques as the gold standard. However, semi-quantitative methods such as urine reagent strips show promise as cost-effective and rapid screening tools. This study aims to evaluate the feasibility of utilizing Meditape UC-11A strips (Sysmex, Kobe, Japan) for albuminuria screening compared to quantitative assays measuring urine albumin-to-creatinine ratio (ACR). METHODS: We systematically analyzed 1,627 strip samples using Meditape UC-11A strips whenever quantitative urinary albumin measurement was required. We compared the ACR measured by strip test with the gold standard (quantitative method determined by Atellica, Siemens, Marburg, Germany) and calculated diagnostic indicators. Additionally, we assessed the economic implications based on test prices (€2.88 for quantitative albumin plus creatinine, and €0.93 for a Meditape UC-11A strip). RESULTS: Receiver operator characteristic (ROC) curve analysis was conducted to determine the optimal cut-off point. The concordance rate achieved using the calculated cut-off point was 90.78 %. Using the quantitative test as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ACR, analyzed using Meditape UC-11A, were 84.2 , 91.9, 62.7, and 97.3 %, respectively. Our findings suggest a potential saving of 81.2 % on quantitative tests during the study period, amounting to €2,291.65. CONCLUSIONS: This study supports the use of Meditape UC-11A strips for detecting abnormal levels of albuminuria, thus offering a viable alternative to quantitative measurement methods. Substantial cost savings can be achieved through this approach.