Multicentre evaluation of the urine analyser Miditron® Junior

• Published in: Scandinavian journal of clinical and laboratory investigation 1997-11, Vol.57 (7), p.605-611
• Main Authors: GAMBKE, B, KOURI, T, KUTTER, D, NAGEL, D, VUKOVICH, T, WEFERS, A
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Colorimetry; Evaluation Studies as Topic; Humans; Investigative techniques, diagnostic techniques (general aspects); Medical sciences; Miscellaneous. Technology; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Reagent Kits, Diagnostic; Reproducibility of Results; Urinalysis - instrumentation; Urinalysis - methods; Urinalysis - standards; Urine - chemistry
• ISSN: 0036-5513; 1502-7686
• DOI: 10.3109/00365519709055284

A multicentre evaluation of the urine analyser Miditron Junior was performed at four laboratories. The Miditron Junior analyser provides semi-quantitative results for erythrocytes, bilirubin, urobilinogen, ketone bodies, glucose, protein, nitrite, leukocytes, pH and relative density. Accuracy of the Miditron 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.