Evaluation of the CLINITEK® ATLASTM for Routine Macroscopic Urinalysis

Objectives: To evaluate the performance of a new, benchtop, fully automated urine analyzer the CLINITEK® ATLASTM and compare it with the URICHEM 1000 CHEMSTRIP® UA analyzer. Macroscopic analysis included measurement of 8 urine analyte chemistries and specific gravity by the refractive index method (SgRI). Methods: The analytical performance studies conducted were calibration stability, precision (within-run and day-to-day), comparison of results of 437 fresh patient urine specimens, analysis of time performance, and problem logging over a 16-day evaluation period. Results: Satisfactory calibration reproducibility, within-run (n = 10), and day-to-day (n = 16) precision was found because results fell within the ± one color-block by the proposed National Committee for Clinical Laboratory Standards (NCCLS) criteria. Patient results (n = 437) from the 2 analyzers giving the same color-block agreement was found to be for pH, 52%; glucose, 92%; ketones, 86%; protein, 79%; bilirubin, 97%; leukocytes, 72%; blood, 80%; and nitrite, 98%. The concordance defined by the NCCLS criteria as the agreement of results ± one color-block between the 2 analyzers was found to be for pH, 96%; glucose, 99%; ketones, 100%; protein, 95%; bilirubin, 100%; leukocytes, 97%; and blood 86%. The SgRI determined on ATLAS was correlated with the RD-10® Rapid Density analyzer with the following results: slope = 0.97, intercept = 0.033, r = 0.94, Syx = 0.003, for a range of values from 1.002 to 1.070. Conclusion: Our preliminary data indicate that the analytical performance, and automatable features for complete walk-away function of this analyzer can significantly increase the overall testing efficiency in the urinalysis laboratory