Background: Several automated urine sediment analyzers have been introduced to clinical laboratories. Automated microscopic pattern recognition is a new technique for urine particle analysis. We evaluated the analytical and diagnostic performance of the UriSed automated microscopic analyzer and compared with manual microscopy for urine sediment analysis.
Methods: Precision, linearity, carryover, and method comparison were carried out. A total of 600 urine samples sent for urinalysis were assessed using the UriSed auto-mated microscopic analyzer and manual microscopy.
Results: Within-run and between-run precision of the UriSed for red blood cells (RBC) and white blood cells (WBC) were acceptable at all levels (CV < 20%). Within-run and between-run imprecision of the UriSed testing for cast, squamous epithelial cells (EPI), and bacteria (BAC) were good at middle level and high level (CV < 20%). The linearity analysis revealed substantial agreement between the measured value and the theoretical value of the UriSed for RBC, WBC, cast, EPI, and BAC (r > 0.95). There was no carryover. RBC, WBC, and squamous epithelial cells with sensi-tivities and specificities were more than 80% in this study.
Conclusions: There is substantial agreement between the UriSed automated microscop-ic analyzer and the manual microscopy methods. The UriSed provides for a rapid turn-around time.