Preliminary functional evaluation of a home-made biochemical detection system according to NCCLS EP10-A2.

Objective To evaluate the performance of a home-made biochemical testing system.Method The system consists of an OLYMPUS AU 400 biochemical analyzer,Roche c.f.a.s calibrator as well as its non-kit reagents.The testing was performed according to EP10-A2 protocol made by NCCLS to determine the indexes of CK,Tch,Urea and Pi.Their deviations,total imprecision,intercepts,slope rates,nonlinearities,carryover and drifts were calculated.T-test was used for data analysis.Result For measurement of CK,the deviation of low-,mid-,and high-value of Tch were all within the permissive ranges.There were no significant difference between their intercepts,slope rates,nonlinearities,carryover,and drifts.For the Urea,the low value deviation was beyond of permissive range while the mid and high values as well as total imprecision were in the permissive ranges.There were significant difference between the slope rates and no significant difference between their intercepts,nonlinearities,carryover,and drifts.For Pi,the low value deviation was beyond of permissive range while mid and high values as well as total imprecision were in the permissive ranges.There were significant difference between their intercepts and no significant difference between their slope rates,nonlinearities,carryover,and drifts.Conclusion The total imprecision were all less than 1 / 3 CLIA' 88 TEa,with lower carryover and better stability.Further improvement,especially the urea measurement and low Pi value,is required.