Evaluation of the URiSCAN 2 ACR Strip to estimate the urine albumin/creatinine ratios
Evaluation of the URiSCAN 2 ACR Strip to estimate the urine albumin/creatinine ratios
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DOI：
10.1002/jcla.22289
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发表时间：
2018-03-01
影响因子：
2.7
通讯作者：
Woo, Hee-Yeon
中科院分区：
文献类型：
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作者：
Lim, Sangeun;Yu, Hui-Jin;Woo, Hee-Yeon
背景尿白蛋白/肌酐比值（ACR）检测用于筛查慢性疾病患者，如糖尿病、高血压和心血管疾病，这些疾病使他们患肾脏疾病的风险增加。在这里，我们评估了URiSCAN 2 ACR试纸的性能（URiSCAN; YD diagnostics，永仁，韩国），一种半定量的护理点检测（POCT）测定，并且我们将其与现有的POCT测定和定量测定进行比较。（西门子，纽约，美国）。我们评估了URiSCAN 2 ACR条的精密度，并比较了从URiSCAN获得的ACR的结果与作为参考的定量分析的定量结果的ACRITEK的结果。ResultsThe精密度评估的URiSCAN显示的范围之间的截止（C-50）-20%和C-50+20%的界限，C-5-C-95的间隔，与85.8%的置信度。URiSCAN和CARITEK的敏感性和特异性分别为87.7%和72.2%，90.2%和83.0%。URiSCAN与EQUIPITEK及定量法的符合率分别为75.6%和79.1%。在异常范围（30 mg/g）内，URiSCAN与定量法的符合率（78.8%vs75.4%）高于URITEK。
BackgroundThe urine albumin/creatinine ratio (ACR) test is used to screen patients with chronic diseases, such as diabetes, hypertension and cardiovascular diseases that put them at an increased risk of developing kidney disease. Here, we evaluated the performance of the URiSCAN 2 ACR Strip (URiSCAN; YD diagnostics, Yongin, Korea), a semiquantitative point-of-care testing (POCT) assay, and we compared to an existing POCT assay and a quantitative assay.Materials and MethodsA total of 1,020 random urine specimens were analyzed using the semiquantitative URiSCAN 2 ACR Strip and semiquantitative CLINITEK Microalbumin 2 Strip (CLINITEK; Siemens, New York, USA). We evaluated the precision of the URiSCAN 2 ACR Strip and compared the results of the ACR obtained from URiSCAN to those of CLINITEK with the quantitative results of a quantitative assay as a reference.ResultsThe precision evaluation of the URiSCAN revealed a range between the cutoff (C-50)-20% and C-50+20% bounds, the C-5-C-95 interval, with 85.8% confidence. URiSCAN and CLINITEK showed sensitivity and specificity of 87.7% and 72.2%, and 90.2% and 83.0%, respectively. The concordance rates of URiSCAN with CLINITEK and the quantitative assay were 75.6% and 79.1%, respectively. The concordance rate in the abnormal range (30mg/g) between URiSCAN and the quantitative assay were higher than that between CLINITEK and the quantitative assay (78.8% vs 75.4%).ConclusionsURiSCAN showed good precision and comparable sensitivity with lower specificity than those of CLINITEK.