ABSTRACT
Objective To validate the performance parameters of DIRUI FUS-2000 automated urine analyzer declared by the manufacturer.Methods The fresh urine samples were diluted with special diluent to different concentration of suspension according to experimental requirements,then such parameters were validated as the precision,carrying pollution rate,detection limit and reportable range.At the same time,the coincidence rate of red blood cells and white blood cells was also verified in urine samples tested by FUS-2000 according to the result of manual inspection.Results RBC had the low and median values for within-run precision being 7.74％ and 6.13％ respectively,and WBC had the low and median values for within-run precision being 14.35％ and 2.45％ respectively.The negative and positive quality control materials had the between-run precision being 0％ and 3.43％ respectively.The carrying pollution rate was 0.08％ for RBC and 0.57％ for WBC,and the detection limits for RBC and WBC were both 10 ones per Liter.The reportable range was from 10 to 38 754 p/μl for RBC and from 10 to 32 202 p/μl for WBC.The coincidence rate with artificial microscopy was 90.83％ for RBC and 95.83％ for WBC.Conclusion FUS-2000's performance parameters are in line with the requirement,and it can be used for the clinical urine detection.The review criteria of FUS-2000 should be established to improve distinguishing sensitivity and specificity of RBC and WBC in urine.
ABSTRACT
Objective To validate the performance parameters of DIRUI FUS-2000 automated urine analyzer declared by the manufacturer.Methods The fresh urine samples were diluted with special diluent to different concentration of suspension according to experimental requirements,then such parameters were validated as the precision,carrying pollution rate,detection limit and reportable range.At the same time,the coincidence rate of red blood cells and white blood cells was also verified in urine samples tested by FUS-2000 according to the result of manual inspection.Results RBC had the low and median values for within-run precision being 7.74％ and 6.13％ respectively,and WBC had the low and median values for within-run precision being 14.35％ and 2.45％ respectively.The negative and positive quality control materials had the between-run precision being 0％ and 3.43％ respectively.The carrying pollution rate was 0.08％ for RBC and 0.57％ for WBC,and the detection limits for RBC and WBC were both 10 ones per Liter.The reportable range was from 10 to 38 754 p/μl for RBC and from 10 to 32 202 p/μl for WBC.The coincidence rate with artificial microscopy was 90.83％ for RBC and 95.83％ for WBC.Conclusion FUS-2000's performance parameters are in line with the requirement,and it can be used for the clinical urine detection.The review criteria of FUS-2000 should be established to improve distinguishing sensitivity and specificity of RBC and WBC in urine.
ABSTRACT
Objective To evaluate the function of IRISiQ200 full automated urine analyzer and its clinical application of user re-classification function.Methods The reproducibility,linearity and mutual infection rate of IRISiQ200 were detected.116 fresh urine specimen were obtained from outpatient and inpatient at random.After the specimen were detected with IRISiQ200,the doubtful urine sediment images were discriminated repeatedly by user reclassification.The microscopic quantitation in uncentrifuged samples was used as reference.Results IRISiQ200 showed good reproducibility,linearity and lower mutual infection rate.The performances by using iQ-200 were: erythrocytes Y=0.596X+11.353,R2=0.834;leukocytes Y=0.468X+5.745,R2=0.708;epithelial cells Y=0.524X-2.649,R2=0.815.The performances after reclassification: erythrocytes Y=0.895X-3.328,R2=0.997;leukocytes Y=0.786X-1.880,R2=0.976;epithelial cells Y=0.911X-5.502,R2=0.992.Conclusion IRISiQ200 full automated urine analyzer shows excellent performance.There is fine correlation between iQ-200 and microscopic quantitation in uncentrifuged samples,and the urine sediment can be observed intuitively by using reclassification function.The doubtful urine sediment images can be discriminated.It can degrade the instrument error and increase the detection accuracy greatly.[Chinese Medical Equipment Journal,2008,29(2):82-83,85]