To establish and validate auto verification criteria for Beckman Coulter iRECELL workstation, and improve the test efficiency under the promise of ensuring the reliability of the results.

A total of 5 359 urine specimens were collected from the clinical laboratory of five hospitals, namely, the Aerospace Center Hospital of Peking University, the Sixth People′s Hospital Affiliated to Shanghai Jiaotong University, the First Affiliated Hospital of Guangzhou Medical University, the First Affiliated Hospital of Wenzhou Medical University and the Shanxi Provincial People′s Hospital from September 2019 to April 2020. 355 specimens from healthy population were in the reference intervals group, 3 449 specimens were in the criteria establishment group, and 1 555 specimens were in the criteria verification group. Taking the microscopic examination results as the gold standard, the Beckman Coulter iRECELL workstation was used to detect the urine samples, and the auto verification criteria of the iRECELL workstation were established.. Each laboratory carried out strict indoor quality control to ensure the accuracy and stability of the results. The reference range of healthy population and the results of auto verification criteria (including true positive rate, true negative rate, false positive rate, false negative rate and auto verification pass rate) were calculated in the criteria establishment stage. The performance indicators of auto verification criteria were calculated, including effective interception rate, invalid interception rate, effective verification rate, invalid verification rate, automatic verification pass rate and auto verification pass accuracy rate in the criteria verification stage.

Taking the microscopic examination results as the gold standard, the auto verification criteria of Beckman Coulter iRECELL workstation were initially established. The auto verification pass rate was 52.51% (1 811/3 449); the microscopic examination rate was 2.58% (89/3 449); and the false negative rate, false positive rate, true negative rates and true positive rates were 2.26% (78/3 449), 11.86% (409/3 449), 47.00% (1 621/3 449) and 38.88% (1 341/3 449) respectively. The validation data were consistent with the criteria establishment data and improved to some extent. Finally, 20 auto verification criteria were set. The effective interception rate, invalid interception rate, effective verification rate, invalid verifacation rate and auto verification pass accuracy rate were 38.52% (599/1 555), 10.35% (161/1 555), 49.07% (763/1 555), 2.06% (32/1 555) and 87.59% (1 362/1 555) respectively.

The auto verification criteria for Beckman Coulter iRECELL workstation can improve the efficiency of urine test, reduce manpower and ensure the reliability of the test results

Urinalysis; Auto verification criteria; Criteria validation