Clinical Performance Evaluation of Feces Analyzer KU-F10.

ABSTRACT

BACKGROUND: Systematic performance verification is required before a laboratory can introduce a new measure-ment procedure for reporting results of patient testing. The aim of this study was to explore the basic performance and clinical application value of KU-F10 Feces analyzer. METHODS: We collected 530 fecal specimens in our hospital from October 2019 to February 2020, using manual methods as the gold standard. Then we made a comprehensive evaluation from repeatability, carried pollution rate, coincidence rate of formed element, and coincidence rate of fecal occult blood test. RESULTS: The sensitivity of white blood cells was 90.3%, the specificity was 99.2%, and the coincidence rate with microscopy was 98.7%; the sensitivity of the instrument to detect red blood cells was 90.3%, the specificity was 98.2%, and the coincidence rate with microscopy was 97.7%, The sensitivity of the instrument to detect fungi is 100.0%, the specificity is 98.7%, and the coincidence rate with the microscopy is 98.7%. The sensitivity of the in-strument to detect fat globules is 94.7%, the specificity is 99.0%, the coincidence rate with the microscopy is 98.9%. Comparison of instrumental fecal occult blood test and reagent B fecal occult blood result: On the 387 cases tested fecal samples, the sensitivity of the instrument was 83.8%, the specificity was 96.5%, and the coincidence rate with the results of microscopy was 92.3%. FOB minimum detection limit is 0.1 µg/mL and detection range is 0.1 to 2,000 µg/mL. CONCLUSIONS: The KU-F10 feces analyzer has an advantage of a high degree of automation, simple operation procedures, fast detection speed, improved working environment, improved work efficiency, and higher clinical application value.