Clinical Performance Evaluation of Feces Analyzer KU-F10
| Autor: | Shaoqing Ju, Yingjuan Shi, Fang Bao, Hui Cong |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Detection limit
Spectrum analyzer business.industry Fecal occult blood Clinical performance Gold standard (test) Repeatability Sensitivity and Specificity General Biochemistry Genetics and Molecular Biology Coincidence Automation Feces Occult Blood parasitic diseases Leukocytes Humans Medicine Colorectal Neoplasms Nuclear medicine business |
| Zdroj: | Clinical Laboratory. 67 |
| ISSN: | 1433-6510 |
| DOI: | 10.7754/clin.lab.2020.200512 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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