Diagnostic Utility of the URiSCAN 2 ACR Strip as a Point-of-care Test for Estimating Urine Albumin-Creatinine Ratios

Jimyung Kim; Jinsook Lim; Sun Hoe Koo; Gye Cheol Kwon

doi:10.3343/lmo.2014.4.3.140

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Kim, Lim, Koo, and Kwon: Diagnostic Utility of the URiSCAN 2 ACR Strip as a Point-of-care Test for Estimating Urine Albumin-Creatinine Ratios

Original Article

Clinical Chemistry

Laboratory Medicine Online 2014; 4(3): 140-145.

Published online: 1 July 2014

DOI: https://doi.org/10.3343/lmo.2014.4.3.140

Diagnostic Utility of the URiSCAN 2 ACR Strip as a Point-of-care Test for Estimating Urine Albumin-Creatinine Ratios

Jimyung Kim, M.D., Jinsook Lim, M.D., Sun Hoe Koo, M.D., Gye Cheol Kwon, M.D.

Department of Laboratory Medicine, College of Medicine, Chungnam National University, Daejeon, Korea.

Corresponding author: Gye Cheol Kwon. Department of Laboratory Medicine, Chungnam National University Hospital, 282 Moonhwa-ro, Joong-gu, Daejeon 301-721, Korea. Tel: +82-42-280-7799, Fax: +82-42-257-5365, kckwon@cnu.ac.kr

Received 26 July 2013 Revised 23 October 2013 Accepted 28 October 2013

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Diagnosing albuminuria by measuring the urinary albumin-creatinine ratios (UACR) is important for the early detection of kidney diseases in patients with diabetes or hypertension. Currently, a few point-of-care testing (POCT) systems exist for estimating the UACR. Here, we evaluated the performance characteristics of two semi-quantitative UACR POCT assays.

Methods

Albumin and creatinine levels were quantified for 219 randomly acquired urine samples with the Toshiba TBA-200FR NEO analyzer, and the UACR were calculated. The results were compared to UACR measured using the CLINITEK Microalbumin 2 Strip (Siemens, USA) and URiSCAN 2 ACR Strip (YD diagnostics, Korea) POCT assays.

Results

Semi-quantitative results from the CLINITEK and URiSCAN UACR assays showed that the sensitivity and specificity of each test were, respectively, 96.7% and 62.7%, and 45.9% and 84.8%. Positive and negative predictive values of the CLINITEK and URiSCAN tests were, respectively, 50.0% and 98.0%, and 53.8% and 80.2%. The rate of agreement between URiSCAN test and CLINITEK test was 91.1% in the normal UACR range (<30 mg/g), but it was as low as 36.4% in the abnormal UACR range (≥30 mg/g).

Conclusions

The URiSCAN test showed higher specificity than did the CLINITEK test owing to the lower false positive results. However, the high rate of false negatives for the URiSCAN test significantly lowered its sensitivity and negative predictive values. Therefore, the sensitivity of the URiSCAN device in detecting urine albumin needs to be improved before its adoption as a reliable rule-out testing system.

Keywords: Albuminuria, Albumin-creatinine ratio, Kidney disease, Point-of-care testing, Random urine

Figures and Tables

Table 1

Comparison of 2 semi-quantitative POCT Assays (URiSCAN 2 ACR Strip and CLINITEK Microalbumin 2 Strip) with the TBA-200FR quantitative assay for UACR

Abbreviations: UACR, urine albumin-creatinine ratio; POCT, point-of-care testing.

Table 2

Sensitivity, specificity, positive and negative predictive values of 2 semi-quantitative POCT assays (URiSCAN 2 ACR Strip and CLINITEK Microalbumin 2 Strip) for the detection of UACR ≥30 mg/g

Abbreviations: UACR, urine albumin-creatinine ratio; POCT, point-of-care testing.

Table 3

Distribution of UACR results of 2 semi-quantitative POCT assays (URiSCAN 2 ACR Strip and CLINITEK Microalbumin 2 Strip)

Abbreviations: UACR, urine albumin-creatinine ratio; POCT, point-of-care testing.

Notes

This article is available from http://www.labmedonline.org

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