Multicentre evaluation of the urine analyser Miditronr` Junior

Abstract

A multicentre evaluation of the urine analyser Miditronr` Junior was performed at four laboratories. The Miditronr` Junior analyser provides semi-quantitative results for erythrocytes, bilirubin, urobilinogen, ketone bodies, glucose, protein, nitrite, leukocytes, pH and relative density. Accuracy of the Miditronr` Junior analyser was evaluated by comparison to quantitative analytical chemistry methods (glucose, total protein), physical methods (pH, relative density), and microscopic methods (erythrocytes, leukocytes). Agreement was defined as identical or neighbouring concentration block. The level of agreement found with chemical, physical or microscopic methods for the six analytes tested varied from 79 to 99%. The within-run precision was determined as repeatability by using 31 native urines. The results of repeated measurements (n=10) fell in the same concentration block, or in case of borderline concentration were spaced between two adjacent colour blocks. Day-to-day precision covering a minimum of 20 days using commercially available control solutions yielded results within ± one colour block from the mean.

Key Words:

• automation
• reflectance colorimetry
• test evaluation
• urinalysis