Multi-center validation study finds 87.6% auto verification pass accuracy rate for urine analysis workstation

Multi-center study finds 87.59% auto verification pass accurate rate

A multi-center study analyzing 5,359 urine specimens collected from the clinical laboratories of five hospitals set out to establish and validate auto verification criteria (iWARE Data Management Software) for the iRICELL urinalysis workcell solution and improve the test efficiency by ensuring the reliability of the results. A total of 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. 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.

The study concluded:

  • The auto verification criteria for iRICELL urinalysis workcell can improve the efficiency of urine tests, reduce manpower and ensure the reliability of the test results
  • Taking manual microscopic examination results as the gold standard, the auto verification criteria of iRICELL urinalysis workcell 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
  • A total of 20 independent auto verification criteria were determined, including 17 screen review criteria, 2 microscopic examination criteria and one dry chemical confirmation criterion
  • The effective interception rate, invalid interception rate, effective verification rate, invalid verification 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
  • With the application of the auto verification criteria, the rate of manual microscopic re-examination is notably lowered

At a Glance

5359
Urine samples collected
87.59 %
(1,362/1,555) Auto verification pass accuracy rate
3.9 %
(48/1,555) False negative rate

Source: Liu Xuekai, Chen Weibin, Li Xiaolong, et. al. Establishment and validation of auto verification criteria for urine analysis workstation in a multi‐center study [J]. Chinese Journal of Laboratory Medicine, 2020, 43(12): 1225-1231. DOI: 10.3760/cma.j.cn114452-20200427-00433.