Abstract:

Objective To establish an automatic urine analysis system audit rule and evaluate its clinical application effects. Methods Totally，112 753 urine samples were collected at the First Affiliated Hospital of Air Force Military Medical University from April 2019 to August 2020. According to the WS/T 616—2018 "Automatic Audit of Clinical Laboratory Quantitative Inspection"，urine analysis line（2 urine dry chemical analyzers and 3 urine visible composition analyzers） operation platform was used. In combination with the self-established relevant determination system，the urine determination reference interval，hemoglobin（Hb），red blood cell（RBC），leukocyte esterase（LEU） and white blood cell（WBC） grade corresponding confirmation relationship was determined. With the results of artificial microscopy as the gold standard，the audit rules of urine analysis line operation platform were established. The validity of audit rule was verified by true negative rate，false negative rate，true positive rate，false positive rate，microscopy rate，automatic audit and manual audit agreement rate（correct rate）. The clinical effectiveness was evaluated according to audit time. Results A total of 25 automatic urine analysis system audit rules and Delta Check rules were established. Validity verification results showed that the true negative rate was 44.03%（487/1 106），the false negative rate was 4.52%（50/1 106），the true positive rate was 29.75%（329/1 106），the false positive rate was 21.70%（240/1 106），and the microscopy rate was 33.54%（371/1 106）. The agreement rate between automatic audit and manual audit was 100.00%（7 338/7 338）. The results of clinical effectiveness evaluation showed that the total pass rate during the trial operation period from May to August 2020 was 65.0%. Compared with May to August 2019，the median audit times of non-microscopy samples and microscopy samples were decreased by 10.3 and 9.3 min from 8：00 to 11：00 daily from May to August 2020，the audit effectivenesses were increased by 47.0% and 18.3%，and the number of auditors was decreased by 1，respectively. Conclusions The established automatic urine analysis audit rule can ensure the quality requirements，improve work efficiency and have good clinical applicability.

Key words: Urine analysis, Automatic audit, Clinical effectiveness