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Annales de Biologie Clinique. Volume 63, Number 6, 619-26, Novembre - Décembre 2005, article original

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Author(s) : J Steinmetz, J Henny, R Gueguen

Summary : The aim of this study was to evaluate the automated urine test strip analyzer Aution Max AX 4280 which uses strips able to measure 12 urinary parameters. For precision study, we considered glucose, protein, blood, leukocytes, nitrite, and pH and the four first were compared with usual methods: chemical measurement or microscopic examination. Reproducibility of the semi quantitative results was determined as the proportion of results falling into the same concentration range. Within-run reproducibility assessed using urine specimens were between 83% and 96%. Between day on quality controlled materials, it was higher (96%), and leukocytes were shared between two classes 250 and 500 cells/μL. For glucose and proteins, linearity was good and comparison with quantitative methods yielded high correlation. The false negative fraction was low and there was no false positive results. For blood, fraction of false positive was 7.5% for 0.3mg/L of hemoglobin compared with microscopic analysis and false negative fraction was 1.3%. For leukocytes, false positive fraction was 4%, false negative one was 7.8%. These results, values for sensitivity, specificity, predictive positive value, predictive negative value permitted to determine the cut-off values to realize second levels analysis: proteins are measured from 0.30g/L, glucose from 2.8 mmol/L, microscopic urinalysis was performed from hemoglobin more than 0.3mg/L and leukocytes more than 25 cells/μL.

Keywords : urinary test strip, automated urine test strip analyzer Aution Max AX 4280, glucose, proteins, blood, leukocyte