Performance validation of CLINITEK Atlas urine dry chemistry analyzer and its supplementary strips in clinical laboratory / 中华检验医学杂志

ABSTRACT

Objective To evaluate the clinical performance of CLINITEK Atlas urine dry chemistry analyzer and its supplementary strips,which could be used for other hospitals as reference.Methods Five hundred and one samples of random fresh urine were collected and analyzed by CLINITEK Atlas urine dry chemistry analyzer.10 parameters were reported for each sample,including SG,pH,BLD,LEU,PRO,GLU,KET,UBG,BIL and NIT.According to the medicals standard of the People's Republic of China,General Technical Requirements for Urine Analyzer(YY/T 0475-2004),General Technical Requirements for Chemical Reagent Strips for Urinalysis(YY/T 0478-2004)and physical,Chemical and Microscopic Examination of Urine(WS/T 229-2002),the precision,accuracy,carryover,stability,sensitivity and consistency of each parameter were evaluated.The agreement was assessed between the results for BLD and LEU obtained from CLINITEK Atlas analyzer and phase contrast microscope,and calculated the sensitivity and specificity of CLINITEK Atlas analyzer for BLD and LEU using phase contrast microscope as the gold standard.SG and pH test was performed among 200 specimens by CLINITEK Atlas analyzer,and then compared with the results obtained from MASTER-SUR-NM specific gravity refractometer and pH precision test strips respectively.In addition to SG and pH,the other eight parameters were compared with the results obtained from CLINITEK 500 urine analyzer,and Kappa value and consistency were calculated.Results The accuracy,precision,sensitivity,carryover and stability of 10 parameters could meet all the requirement of standards.SG and pH had good correlation with urine specific gravity refractometer (r =0.9838,P ＜0.001)and pH meter (r =0.8884,P ＜0.001),respectively.Compared with phase contrast microscope,BLD and LEU had coincidence rates of 90.4％ and 90.8％,respectively; Sensitivities were 90.7％ (301/332) and 83.3％ (200/240) ; Specificities were 89.9％ (152/169) and 97.1％ (255/261).Compared with CLINITEK 500,all the parameters,except for SG and pH,had good coincidence rates of ＞ 87.6％.Conclusion The performance of CLINITEK Atlas urine dry chemistry analyzer can meet the clinical requirements of all standards.