Abstract:

Objective To evaluate the performance of CS-5100 automatic blood coagulation analyzer for the determinations of antithrombin Ⅲ（AT Ⅲ）,protein C（Pc） and protein S（Ps） activities. Methods According to the Clinical and Laboratory Standards Institute （CLSI） guidelines,the imprecision [coefficient of variation （CV）],accuracy,linearity,carry-over rate and reference interval of CS-5100 for the determinations of AT Ⅲ,Pc and Ps activities were validated. Results The within-run CV of CS-5100 for the determinations of AT Ⅲ,Pc and Ps activities were <1.9%,and the inter-day CV were <4.1%,meeting manufacturers' requirements. The bias of accuracy verification results was within biology CV requirements. The linear regression equation between AT Ⅲ linear validation theoretical value and measured values met the slope of 1±0.05,the determination coefficient （r²）≥0.95 and carry-over CV<10%. Reference interval verification results showed that the determination index R was ≥0.9. Conclusions The precision,accuracy,linearity,carry-over rate and reference interval of CS-5100 meet the requirements of quality control,which can ensure determination quality.

Key words: Automatic blood coagulation analyzer, Antithrombin Ⅲ, Protein C, Protein S, Performance verification