Performance evaluation of DIRUI FUS-2000 automated urine analyzer for detecting urinary RBC and WBC
10.7687/j.issn1003-8868.2017.08.082
- VernacularTitle:迪瑞FUS-2000全自动尿液分析仪检测尿液红细胞、白细胞的性能评价
- Author:
wei Wei CUI
1
;
ping Yan MEI
;
lin Zhen NIE
;
shan Yi WANG
Author Information
1. 南京医科大学附属南京医院医学检验科
- Keywords:
automated urine analyzer;
urine;
red blood cell;
white blood cell;
performance evaluation
- From:
Chinese Medical Equipment Journal
2017;38(8):82-85
- CountryChina
- Language:Chinese
-
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.
