Open AccessEvaluation of the UR i SCAN 2 ACR Strip to estimate the urine albumin/creatinine ratios
Author(s) -
Lim Sangeun,
Yu HuiJin,
Lee Seungjun,
Park Hyosoon,
Kwon MinJung,
Woo HeeYeon
Publication year - 2018
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.22289
Subject(s) - urine , creatinine , concordance , medicine , confidence interval , reference range , quantitative analysis (chemistry) , point of care testing , albumin , chromatography , urology , chemistry , nuclear medicine , pathology
Background The 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 UR i SCAN 2 ACR Strip ( UR i SCAN ; 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 Methods A total of 1,020 random urine specimens were analyzed using the semiquantitative UR i SCAN 2 ACR Strip and semiquantitative CLINITEK Microalbumin 2 Strip ( CLINITEK ; Siemens, New York, USA ). We evaluated the precision of the UR i SCAN 2 ACR Strip and compared the results of the ACR obtained from UR i SCAN to those of CLINITEK with the quantitative results of a quantitative assay as a reference. Results The precision evaluation of the UR i SCAN revealed a range between the cutoff (C 50 )−20% and C 50 +20% bounds, the C 5 ‐C 95 interval, with 85.8% confidence. UR i SCAN and CLINITEK showed sensitivity and specificity of 87.7% and 72.2%, and 90.2% and 83.0%, respectively. The concordance rates of UR i SCAN with CLINITEK and the quantitative assay were 75.6% and 79.1%, respectively. The concordance rate in the abnormal range (≥30 mg/g) between UR i SCAN and the quantitative assay were higher than that between CLINITEK and the quantitative assay (78.8% vs 75.4%). Conclusions UR i SCAN showed good precision and comparable sensitivity with lower specificity than those of CLINITEK .