Evaluation of Dirui® H13-Cr and H12-800MA strips for albuminuria detection

Abstract

Increased urine albumin excretion is suggested to be an early marker of glomerular damage. Evaluation of a test’s performance characteristics such as diagnostic sensitivity and specifictiy is a necessity before application into routine practice. To our knowledge up to now there is no study evaluating Dirui test strips for albuminuria determination. Therefore the objective of this study was to test these strips for agreement with the established method used in our routine laboratory. Freshly collected 177 urine specimens were included in the study. Strips were read on instruments Dirui H-500 and Dirui H-800 using reflectance photometry. For DiruiH13-Cr strip albumin to creatinine ratio (ACR) and for DiruiH12-800MA strip albumin determinations were compared with the analyses performed using immunoturbidimetry and kinetic Jaffe method. Sensitivity values for estimated ACR using DiruiH13-Cr strip and albumin concentration using DiruiH12-800MA strip were calculated as 80%, 72%, respectively. Specificity values were as; 71% for Dirui H13-Cr strip and 78% for Dirui H12-800MA strip. Screening tests using urine test strips should be validated before acceptance in the routine use. Dirui strips evaluated in this study seem to have a lower sensitivity than suggested and excess number of false negatives seems to limit utility of these strips. [Med-Science 2018; 7(3.000): 532-5]

Keywords

• Urine albumin
• albumin to creatinine ratio
• strip
• sensitivity
• screening