Performance Evaluation of MEDITAPE UC-11A Strip Test in Estimating the Urine Albumin-to-Creatinine Ratio and Urine Protein-to-Creatinine Ratio
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Background: Proteinuria, including albuminuria, is a primary or major clinical sign of kidney disease. The urine albumin-to-creatinine ratio (UACR) and urine protein-to-creatinine ratio (UPCR) are used to screen patients with chronic diseases, such as diabetes and hypertension, which increase the risk of chronic kidney disease. Here, we evaluated the performance of the MEDITAPE UC-11A strips (Sysmex, Japan), compared with that of the quantitative assay, in assessing UACR and UPCR. Methods: We obtained a total of 808 random urine specimens. UACR and UPCR, semiquantitatively analyzed using MEDITAPE UC-11A strips with a UC-3500 automated strip reader (Sysmex, Japan), were compared to UACR and UPCR measured by a quantitative assay. Results: The concordance rates of UACR and UPCR, analyzed using MEDITAPE UC-11A, and those analyzed using the quantitative assay, were 70.1% and 78.7%, respectively. Using UACR, analyzed via quantitative assay, as a reference to estimate albuminuria (UACR >30 mg/g), the concordance rate, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of UACR, analyzed using MEDITAPE UC11A, were 80.5, 97.5, 67.0, 70.3, and 97.1%, respectively. Using UPCR, analyzed via quantitative assay, as a reference to estimate proteinuria (UPCR >0.15 g/g), the concordance rate, sensitivity, specificity, PPV, and NPV of UPCR, analyzed using MEDITAPE UC-11A, were 86.7, 94.4, 81.5, 77.6, and 95.6%, respectively. Conclusions: UACR and UPCR, analyzed using MEDITAPE UC-11A, exhibited relatively high sensitivity and NPV, which is beneficial for laboratory screening for both albuminuria and proteinuria.
Abstract
Background: Proteinuria, including albuminuria, is a primary or major clinical sign of kidney disease. The urine albumin-to-creatinine ratio (UACR) and urine protein-to-creatinine ratio (UPCR) are used to screen patients with chronic diseases, such as diabetes and hypertension, which increase the risk of chronic kidney disease. Here, we evaluated the performance of the MEDITAPE UC-11A strips (Sysmex, Japan), compared with that of the quantitative assay, in assessing UACR and UPCR. Methods: We obtained a total of 808 random urine specimens. UACR and UPCR, semiquantitatively analyzed using MEDITAPE UC-11A strips with a UC-3500 automated strip reader (Sysmex, Japan), were compared to UACR and UPCR measured by a quantitative assay. Results: The concordance rates of UACR and UPCR, analyzed using MEDITAPE UC-11A, and those analyzed using the quantitative assay, were 70.1% and 78.7%, respectively. Using UACR, analyzed via quantitative assay, as a reference to estimate albuminuria (UACR >30 mg/g), the concordance rate, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of UACR, analyzed using MEDITAPE UC11A, were 80.5, 97.5, 67.0, 70.3, and 97.1%, respectively. Using UPCR, analyzed via quantitative assay, as a reference to estimate proteinuria (UPCR >0.15 g/g), the concordance rate, sensitivity, specificity, PPV, and NPV of UPCR, analyzed using MEDITAPE UC-11A, were 86.7, 94.4, 81.5, 77.6, and 95.6%, respectively. Conclusions: UACR and UPCR, analyzed using MEDITAPE UC-11A, exhibited relatively high sensitivity and NPV, which is beneficial for laboratory screening for both albuminuria and proteinuria.
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