Study on the quality management of biological variation allowed total error in detection of serum lipid / 国际检验医学杂志

ABSTRACT

Objective To study on the application of biological variation total allowable error in quality management of serum lipid detection .Methods The σ score ,quality goal index (QGI) ,priority improvement measures and performance evaluation of lipid accuracy criteria were evaluated ,including cholesterol (CHOL) ,triglyceride (TG) ,high density lipoprotein (HDL‐C) ,low density lipoprotein (LDL‐C) ,which included in the standard of accuracy of the Ministry of Health in 2015 .The reason for unsatisfactory re‐sults of cholesterol (CHOL) test were analyzed .Results Based on the three levels of quality specifications derived in biological var‐iation ,when the total allowable error was located at an appropriate level ,the σ score of TG ,HDL‐C ,LDL‐C reached 6 ,it was not re‐quired for improvement .While the score of CHOL performance analysis was poor ,accuracy was required to give priority to impro‐ving .When the total allowable error reached the best level ,only the σ score of TG achieved “good” in the four items ,improvement of precision was needed .When the total allowable error was located at the lowest level ,the σ score of TG ,HDL‐C ,LDL‐C was grea‐ter than 6 ,the score of performance analysis reached the “excellent” .The σ score of CHOL (2 .9) had been closen to 3σ ,accuracy was required to be corrected .Conclusion The biological variation derived total allowable error is easy to meet the requirements of the quality management in serum lipid determination by current technologies and methods .The theory of 6σ quality can reflect the performance of detection indexes ,and improve the quality of analysis effectively .