자동 요분석기 CLINITEK Novus의 성능 평가

Abstract

Background: We aimed to evaluate the performance of the CLINITEK Novus urine chemistry analyzer (Siemens, UK).

Methods: The precision, correlation, and carryover study were performed using two kinds of commercial quality control materials and 40-55 freshly collected patient specimens. We calculated exact and within-1-block agreement, along with kappa agreement, to compare the semi-quantitative results between urine chemistry analyzers. The urine specific gravity taken by a refractometer was compared with the analyzer results. Moreover, we analyzed additional urine specimens for protein to evaluate the agreement of results between those of the CLINITEK Novus and the AU680 analyzers (Beckman Coulter, Japan).

Results: The precision study showed acceptable results; within-1-block agreement was 100% in all tested items. The urine chemistry results from the CLNITEK Novus analyzer demonstrated ≥85.1% within-1-block agreements with those of the Uriscan Super, and the kappa test results were ≥0.81. The comparison of specific gravity with manual refractometer showed a good correlation (r=0.991), and the protein comparison with the AU680 analyzer also showed a good correlation (with exact and within-1-block agreements being 75.9% and 100.0%, respectively). The carryover rates were 0% in all tested items, except specific gravity and heavy blood tests.

Conclusions: The CLINITEK Novus analyzer showed good performance in terms of precision, comparison, and carryover in this study. Therefore, the CLINITEK Novus automated urine analysis is expected to be useful for routine urinalysis in a clinical laboratory.