目的：2019年2月CLIA公佈新版標準。大多數生化定量項目的TEa都縮小，僅少數項目(如Cl、Na、T.CHOL等)維持不變。應用TEa在生化定量分析內部品管，主要在計算Sigma值及評估選擇品管規則與品管次數等。本研究主要探討2019年版TEa標準在生化分析內部品管的影響。材料與方法：評估2019年5至2019年10月期間。以Beckman Coulter® DxC 700 AU生化分析儀器，評估 14項生化項目。比較2003年及2019年的TEa標準，以EZ rules 3評估各生化項目的Sigma值，及選擇品管規則與品管次數，偵錯率(Ped) 與假拒絕率(Pfr)。以Windows Excel(2016版)統計各生化項的品管失敗率。結果：(1) 2019年TEa與2003年TEa標準的Sigma值大致相近。2019年TEa下修百分比較大的項目，其2003年的Sigma值也較高。2019年TEa標準縮小超過40％的4項目(AMY、UA、MG、TG)，在2003年標準其Sigma值也高達20％。(2)TEa下修幅度與Sigma變化幅度一致。比較新舊TEa標準所得之Sigma值，發現所有15個品項，Sigma值與TEa標準的變化成正比。(3)2019年的TEa其Sigma值有明顯的改善。比較新舊TEa標準所得之Sigma值，發現4個項目可降至20甚至10以內，而有7項目由超過10降至接近10或低於10。(4)14項生化項目的偵錯率(Ped)與假拒絕率(Pfr)無明顯變化。大多數項目可維持Ped > 98 %與 Pfr < 5 %，與舊標準時無明顯變化。唯CRE與TP兩項因調整後的Sigma值小於6，品管規則須改為13s/22s/R4s/41s才能達到Ped > 95 % 與 Pfr < 5 %之要求。(5)品管規則改變後的品管失敗率，TP由0%上升至2%，而CRE則仍維持0%。結論：過去檢驗室使用2003年TEa標準，各生化項目的Sigma值較大，多數項目都為單一品管規則，無法呈現真實的Ped 與 Pfr，及無法早期偵測出系統性或隨機性誤差。引用2019年TEa標準，各生化品項的Sigma值降低，對於品管失敗率影響不大，能呈現真實的Ped與 Pfr，因此更能符合內部品質管制的要求。

Purpose: CLIA announced a new version of the standard in February 2019. The TEa of most biochemical quantitative items have been narrowed, and only a few items (such as Cl, Na, T.CHOL, etc.) remain unchanged. The application of TEa in the biochemical quantitative analysis of internal quality control is mainly used to calculate the Sigma value, evaluate the selection of quality control rules and quality control times. This study mainly explores the impact of the 2019 TEa standard on the internal quality control of biochemical analysis. Materials and methods: During the period from May 2019 to October 2019, 14 biochemical items were evaluated With Backman Coulter AU680 biochemical analysis instrument. Compared the TEa standards in 2003 with 2019, we use EZ rules 3 to evaluate the Sigma value of each biochemical item, selecting quality control rules and quality control times, error detection rate (Ped) and false rejection rate (Pfr). We use Windows Excel (2016 version) to calculate the quality control failure rate of each biochemical item. Results: (1) The Sigma value of TEa in 2019 and the TEa standard in 2003 are roughly similar. Items with a large percentage of TEa under revision in 2019 have a higher Sigma value in 2003. The 4 items (AMY, UA, MG, TG), whose TEa standard has been narrowed by more than 40% in 2019, have a high Sigma value as 20% in 2003. (2) The range of TEa downward revision is consistent with the change range of Sigma. Compared the Sigma values obtained from the new with old standard of TEa, it is found that the Sigma values for all 15 items are proportional to the change in the TEa standard. (3) The Sigma value of TEa in 2019 has been significantly improved. Comparing the Sigma values obtained from the new and old TEa standards, it is found that 4 items can be reduced to 20 or even less than 10, and 7 items fall from more than 10 to close to 10 or less than 10. (4) There was no significant change in the error detection rate (Ped) and false rejection rate (Pfr) of the 14 biochemical items. Most projects can maintain Ped> 98% and Pfr <5%, and there is no significant change from the old standard. Only the adjusted Sigma values of CRE and TP are less than 6, and the quality control rules must be changed to 13s/22s/R4s/41s to meet the requirements of both Ped> 95% and Pfr <5%. (5) The failure rate of quality control of TP are increasing from 0% to 2%, while CRE remains 0% after the change of quality control rules. Conclusion: In the past, the laboratory facility used the standard of 2003 in TEa, and the Sigma value of each biochemical items was relatively broad. Most of the items were under a single quality control rule, which could not only present the true Ped and Pfr, but also not detect early systematic or random errors. Quoting the 2019 TEa standard, the Sigma value of each biochemical items is reduced, which has little effect on the failure rate of quality control. It can show the real Ped and Pfr, so it can better meet the requirements of internal quality.