J Clin Pathol Qual Control.
2001 Dec;23(2):299-306.
Laboratory Evaluation of Fully Automated Urine Cell Analyzer Sysmex UF-100
- Affiliations
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- 1Department of Clinical Pathology, Seoul National University Hospital, Seoul, Korea. jqkim@plaza.snu.ac.kr
Abstract
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BACKGROUND: During last decades there have been needed to establish the automation of urinary sediments in laboratory. UF-100 is designed to automatically classify particles by size without painstaking pretreatments, such as sample centrifugation, staining and making preparations. UF-100 is a flow cytometry using forward scattered light and fluorescence for identifying, clustering and counting the various urine sediments according to their size and contents. Thus we evaluated the performance of UF-100 for routine urinalysis.
METHODS
UF-100 was evaluated for its within-run, within-day, between-day using control material, UF-CHECK(Lot. A009). Within-day was estimated by 10 samples for one day, between-day was estimated by 2 samples per day for 30 days. The linearity was estimated by using urine specimens that were serially diluted for Parameters(RBC, WBC, epithelial cell and bacteria). The accuracy study was done by comparing the results of UF-100 with those of microscopic examination on 1890 urine specimens. The review rate was analyzed by the flags of UF-100 on 2049 urine specimens. All results on 517 urine specimens of outpatient were calculated in the 2.5- and 97.5 percentiles (Excel 2000, Microsoft co., USA) for reference range. We analyzed RBC-P70FSC(RBC-percentage 70 forward scatter light) and RBC-FSC- DW(RBC-forward scatter light-distribution width) of the 50 samples with dysmorphic RBC results over 70% in microscopy using UF-100.
RESULTS
Coefficients variation of within-run, within-day, and between-day precision were good, but the case of casts was more or less high. The linearity study of Parameters was revealed R2 = 0.9997, 0.9999, 0.9972, 0.9807. The accuracy study of concordance rate of RBC, WBC, epithelial cell were 94.0%, 94.0%, 97.3% in outpatients, 89.5%, 90.8%, 93.0% in inpatients. The instrument review rate(total count error, RBC discrimination error, conductivity error) and the parameter review rate(pathological cast, crystal, small round cell, sperm, yeast like cell) of UF-100 were 19.6% on 1008 samples in outpatients, 39.0% on 1041 samples in inpatients. Upper reference limits of RBC, WBC, epithelial cell, cast, bacteria, pathological cast, crystal, small round cell were 15.06/microliter, 15.61/microliter, 11.11/microliter, 1.66/microliter, 6558.56/microliter, 0.31/microliter, 7.42/microliter, 1.60/microliter. The high limits of confidence interval 99% for dysmorphic RBC over 70% in microscopy were RBC-P70FSC 74.75ch and RBC-FSC-DW 40.17ch.
CONCLUSIONS
UF-100 was satisfactory in results of within-run, within-day, between-day precision and linearity. The accuracy study of concordance of Parameters between UF-100 and microscopic examination showed acceptable. In conclusion, UF-100 is expected to be useful for urinalysis in routine laboratory.