COBIO-Arkray Verification News

We just finished a verification project ofmulticenter research for the urinalysis workstation which is under the cooperation with Arkray, China-Japan Friendship Hospital and Eye Hospital China Academy of Chinese Medical Sciences. The purpose of this multi-center research plan is to verify the performance of the COBIO S80 automatic urine sediment analyzer, and according to the results of the automatic urine analysis workstationcombined by Arkray AX-4030 and COBIO S80 to develop different re-inspection rules according to different hospitals, so as to improve the inspection work efficiency and the quality of results.

The verification workstation includes the Arkray AX-4030 for dry chemistry testing and the COBIO S80 for urine sediment analysis, as well as a bridge to connect the two devices and automatically transfer samples. 2042 human urine samples are collected and tested from May to August 2020 and each sample was counted under the microscope by two experienced technologists in a double-blind method for the evaluation and comparison of the COBIO S80 instrument test results. The results of urine sediment analysis by COBIO S80 were more than 85% consistent with the results of gold standard of manual microscopic examination, less than 5% false negative and less than 10% false positive are found.It can obviously prove thatthe results of COBIO S80 and manual microscopic examination have a high coincidence rate, reflecting better accuracy, which can meet the needs of clinical use. Moreover, according to the results of this multi-center study, the re-inspection rules are also formulated, we carried out 64 rules for selective review and proved that hospitals can individually choose 30-40 rules from them and still get relative accurate results with much less workload.

We will introduce more details of the verification in next time. Thank you for following us.