用6σ法設置生化檢驗項目室內質控目標值

目的：用6西格瑪（6σ）質量管理理論評價載脂蛋白A1（APOA1）、載脂蛋白B（APOB）、β_2微球蛋白（β_2M）、脂蛋白（a）[LP(a)]四個項目的分析性能，並設置這些項目的室內質量控制目標值。方法：收集2021年4月～6月，上述4個項目的室內質控數據，用生物學變異數據及三等分析質量指標值，分別計算每個項目不同分析濃度的σ值。性能評價：σ>4時為優；3<σ<4時為良；2<σ<3時為中；σ<2時為差。結果：在三等分析質量指標下室內質控項目APOA1水平1/水平2的σ值分別為優等1.51/1.68、中等3.82/4.26、低等6.13/6.82；APOB水平1/水平2的σ值分別為優等3.10/4.40、中等6.82/10.2、低等10.8/15.3；β_2M水平1/水平2/水平3的σ值分別為優等1.14/1.66/1.67、中等3.71/4.23/4.26、低等5.95/6.80/6.84；LP（a）水平1/水平2/水平3的σ值分別為優等2.65/4.49/6.49、中等5.80/9.80/14.2、低等8.92/15.1/21.8。結論：通過σ法評價APOA1、APOB、β2M、LP（a）能達到中等質量指標，適合的室內質控目標CV（Coefficient variation, CV）值分別為3.25%、3.45%、2.95%、4.25%。

關鍵字

6σ ；室內質控；目標

並列摘要

Objective: To evaluate apolipoprotein A1 (APOA1), apolipoprotein B (APOB), β2 microglobulin (β2M), lipoprotein (a) [LP(a)] with 6 sigma (6σ) quality management theory. To analyze the performance of each item, and set the internal quality control target value of these items. Methods: To collect the internal quality control data of the above 4 items from April to June 2021, and use the biological variation data and the third-class analysis quality index values to calculate the σ value of the different analysis concentrations of each item. Performance evaluation: σ>4 is excellent; 3<σ<4 is good; 2<σ<3 is medium; and σ<2 is poor. Results: Under the third-class analysis quality index, the σ values of internal quality control items APOA1 level 1/level 2 were excellent 1.51/1.68, medium 3.82/4.26, and low 6.13/6.82; APOB level 1/level 2σvalues were respectively It is excellent 3.10/4.40, medium 6.82/10.2, low 10.8/15.3; β2M level 1/level 2/level 3's σ values were excellent 1.14/1.66/1.67, medium 3.71/4.23/4.26, low 5.95/6.80 /6.84; the σ values of LP(a) level 1/level 2/level 3 were excellent 2.65/4.49/6.49, medium 5.80/9.80/14.2, and low 8.92/15.1/21.8. Conclusion: The evaluation of APOA1, APOB, β2M, and LP(a) by the σ method can achieve intermediate quality indicators. The suitable internal quality control target CV (Coefficient Variation, CV) values are 3.25%,3.45%, 2.95%, 4.25% respectively.

並列關鍵字

6σ ； Internal quality control ； The goal

主題瀏覽