Assessment of the performance of red blood cells folic acid analyzer / 重庆医学

ABSTRACT

Objective Through performance analysis of domestic red blood cells folic acid instrument to verify its testing ability. Methods According to national committee for clinical laboratory standards(NCCLS)EP5-A2,the precision was obtained through two level quality product detection within 20 days then the intra-assay variation coefficient(CV),inter-assay CV and CV in labora-tory was calculated and compared with the precision requirement coming from the red blood cells folic acid biological variation.Ac-cording to EP6-A,the linear evaluation was investigated with method of polynomial regression.By measuring the red blood cells fo-lic acid from 20 persons who presented the total healthy people,the reference scope given by the manufacturer was verified.Results Within the group CV was less than 6.67%(1/4 of biological variation allow total error),between the group CV was less than 8.90%(1/3 of biological variation allow total error),the laboratory CV was less than 13.35%(1/2 of biological variation allow to-tal error).At medical decision level,the calculated bias and the confidence limit were smaller than the allow range of error.Both fac-tors of quadratic polynomial and cubic polynomial regression models were not statistically significant compared with zero,so detec-tion system was linear.The reference scope given by manufacturer was not suitable for the local people.Conclusion The precision, accuracy and linearity of domestic red blood cells folic acid analyzer were accord with requirements.The laboratory should establish reference interval suitable for the local population.