基于生物学变异的质量规范在室内质控中的应用

目的探讨基于生物学变异导出的允许不精密度（CVA）和允许总误差（TEa）质量规范，在评价常规化学和血液学室内质控中的意义，更好提高实验室的检测水平。方法累计2年来常规生化和血液在控数据的室内质控变异系数（CV），应用CVA和TEa评价AMY、ALT、AST等26项常规生化项目和WBC、RBC、Hb等11项血液项目的不精密度水平，利用微软Excel的函数功能进行统计分析。结果通过室内质量控制在控数据的变异系数监测，与CVA和TEa水平进行比较，计算出在控数据室内质控CV小于基于生物学变异确定的质量规范的百分比。其中，ALT、DBIL、GGT、UREA、UA、TG、CK、K、Fe、WBC、RBC检测项目低、高浓度的CV达到CVA、TEa的最佳评价限；AMY、AST、TP、Alb、AKP、Glu、IP、TC、HDL—C、LDH、CHE、HCY、Hb、MCV、MCH、MCHC、PLT、Fib、Am检、坝0项目低、高浓度的CV达到CVA的适当限和TEa的最佳限；HCT、PT检测项目高浓度的CV达到CVA的最低限，低浓度的CV达到CVA的适当限，低、高浓度的CV达到TEa的期望限；Cr、Ca、Na、C1、Mg检测项目低、高浓度的CV均明显低于CVA的最低限，而基本达到TEa的期望限。结论基于生物学变异导出的CVA和TEa质量规范，可以作为不同层次实验室室内质控的评判标准；对于CV达到CVA最低限而TEa是期望限的检测项目必须进行干预，最大限度控制系统误差。

Application of quality specifications based on biological variation in internal quality control

Objective To explore the significance of allowed imprecision （CVA） and allowed total error （TEa） quality specifications based on biological variation derived in the evaluation routine chemistry and hematology internal quality control （IQC）, better improve laboratory detection level. Methods With 2 years of accumulated routine chemistry and hematology IQC coefficient of variation （CV） in the control data, the imprecision level was estimated with AMY, ALT, AST rank 26 routine chemistry projects and WBC, RBC, Hb rank 11 hematology projects by CVA and TEa, and statistically analyzed using microsoft excel function. Results Through monitoring the IQC cv in the control data, we compared the levels of CVA and TEa, counted the percentage for IQC cv in the control data less than quality specifications based on biological variation to determine. Among them, CV of low and high concentration to CVA, TEa best evaluation limit by ALT, DBIL,GGT,UREA, UA, TG, CK, K, Fe, WBC, RBC ; CV of low, high concentration to CVA proper limit and TEa best limit by AMY, AST, TP, Alb, AKP, Glu, IP, TC , HDL-C, LDH, CHE, HCY, Hb, MCV, MCH, MCHC, PLT, Fib, APTI＇; HCT, Fr cv of high concentration reached CVA minimum limit, CV of low concentration reached CVA proper limit, CV of low and high concentration reached TEa expectations limit ; Cr, Ca, Na, C1, Mg CV of low and high concentration were obviously lower than CVA minimum limit. And basically reached TEa expectations limit. Conclusion Based on biological variation derived CVA and TEa quality specifications, can be used as different levels laboratory evaluation criteria of IQC ; for the test project CV reaching CVA minimum limit and TEa expected limit must be intervened, for maximum limit in controlling systematic error.