EVALUATION OF THE CLINITEK(R) ATLAS(TM) FOR ROUTINE MACROSCOPIC URINALYSIS

Objectives: To evaluate the performance of a new, benchtop, fully auto mated urine analyzer the CLINITEK(R) ATLAS(TM) and compare it with the URICHEM 1000 CHEMSTRIP(R) UA analyzer. Macroscopic analysis included measurement of 8 urine analyte chemistries and specific gravity by the refractive index method (SgRI).Methods: The analytical performance st udies conducted were calibration stability, precision (within-run and day-to-day), comparison of results of 437 fresh patient urine specimen s, analysis of time performance, and problem logging over a 16-day eva luation period. Results: Satisfactory calibration reproducibility, wit hin-run (n =10), and day-to-day (n = 16) precision was found because r esults fell within the +/- one color-block by the proposed National Co mmittee for Clinical Laboratory Standards (NCCLS) criteria. Patient re sults (n = 437) from the 2 analyzers giving the same color-block agree ment was found to be for pH, 52%; glucose, 92%; ketones, 86%; protein, 79%; bilirubin, 97%; leukocytes, 72%; blood, 80%; and nitrite, 98%. T he concordance defined by the NCCLS criteria as the agreement of resul ts +/- one color-block between the 2 analyzers was found to be for pH, 96%; glucose, 99%; ketones, 100%; protein, 95%; bilirubin, 100%; leuk ocytes, 97%; and blood 86%. The SgRI determined on ATLAS was correlate d with the RD-10(R) Rapid Density analyzer with the following results: slope = 0.97, intercept = 0.033, r = 0.94, S-yx = 0.003, for a range of values from 1.002 to 1.070. Conclusion: Our preliminary data indica te that the analytical performance, and automatable features for compl ete walk-away function of this analyzer can significantly increase the overall testing efficiency in the urinalysis laboratory.