尿液沉渣內部品管如何符合品管規則－以符合Westgard Sigma Rules為例

How Does Internal Quality Control of Urine Sediment Comply with Quality Control Rules-Taking Compliance with Westgard Sigma Rules as an Example

范光平(Kuang-Ping Fan)；高竹蘋(Chu-Ping Kao)；利琇美(Hsiu-Mei Li)；張錦標(Jin-Biou Chang)；湯勝輝(Sheng-Hui Tang)

尿沉渣 ； EZ Rules 3 ； Sigma（σ） ； 偵錯率（P_(ed)） ； 假拒絕率（P_(fr)） ； TEa ； Urine sediment ； EZ Rules 3 ； Sigma(σ) ； error detection rate (P_(ed)) ； false rejection rate (P_(fr)) ； TEa

中華職業醫學雜誌

31卷3期（2024 / 07 / 25）

179 - 185

繁體中文;英文

目的：目前國內尿液沉渣的品管規則均採用估算的Sigma（σ）來選擇，其缺點是無法依據σ值選擇出適當的品管規則及品管次數，也無法評估P_(ed)與P_(fr)是否符合品管的管理目標。本研究主要探討品管規則中有不適當的σ值時，使用EZ Rule 3軟體調整選擇適當的TEa，並評估各檢驗項目的P_(ed)與P_(fr)，使能有效達到監控尿沉渣內部品管之品質。材料與方法：評估2022年7月至12月期間，使用UF-CONTROL^(TM)尿液品管液監控Sysmex UF-5000 Urine Sediment Analyzer（Sysmex Corporation^(TM)）尿沉渣分析儀設備效能，探討尿沉渣RBC、WBC、Epithelial Cell、CAST、Bacteria內部品管之品管規則及品管次數的適切性。應用EZ rules 3品管軟體評估內部品管的結果是否符合品管要求。以尿液品管液相對濃度的CAP survey結果，其CV%結果的3倍作為TEa。適當調降TEa，比較不同TEa對於尿沉渣分析內部品管之影響，包括各檢驗項目的σ值、品管規則選擇、品管次數與P_(ed)、P_(fr)之效能表現。結果：以尿液品管液相對濃度的CAP survey結果，其CV%結果的3倍計算各項TEa。RBC、WBC、Epithelial Cell、CAST、Bacteria之TEa分別為40%、40%、120%、160%、40%，將TEa標準適當調降如下：（1）Level 1有2項：Epithelial Cell調降為80%、CAST調降為107%；（2）Level 2有5項：RBC調降為20%、WBC調降為20%、Epithelial Cell調降為40%、CAST調降為80%、Bacteria調降為27%。TEa調整後之σ值變化為：Level 1，Epithelial Cell由12.2降至6，CAST由8.7降至5.7；Level 2，RBC由12.1降至6，WBC由15.9降至7.9，Epithelial Cell由22.1降至7.1，CAST由15.8降至7.8，Bacteria由8.3降至5.4。調整前有多項的σ值>6，造成P_(ed)及P_(fr)偏低，無法有效監控內部品管之表現；將TEa標準適當縮減後，上述各項可維持P_(ed)>90%與P_(fr)<5%，品管次數為2之要求。結論：以CAP survey對應相對品管液濃度的CV%結果的3倍計算各檢驗項目的TEa，來監控內部品管的表現並不完全適當。有可能造成σ值偏高，導致降低P_(ed)與P_(fr)。經適當縮減TEa數值後，可以建立更適合的內部品管監控條件。將過去σ值過高的項目有效降低，並可維持P_(ed)>90%與P_(fr)<5%，品管次數為2之要求。本研究可提供國內實驗室尿沉渣檢查選擇定量分析品管，在設定品管規則時作為參考。

Purpose: Currently, the quality control rules for domestic urine sediment are based on estimated Sigma(σ). The disadvantage is that it can't select appropriate quality control rules and quality control frequency based on the σ value, and it is also impossible to evaluate whether P_(ed) and P_(fr) comply with quality control management objectives. This study mainly discusses how to use EZ Rule 3 software to adjust and select the appropriate TEa when there is an inappropriate σ value in the quality control rules, and evaluate the P_(ed) and P_(fr) of each item to effectively monitor the quality of urine sediment internal quality control. Materials and methods: Perform urine sediment analysis using the Sysmex UF-5000 Urine Sediment Analyzer (Sysmex Corporation^(TM)). Use UF-CONTROL^(TM) urine quality control to monitor the instrument performance of the urine sediment analyzer. Evaluate the performance of internal quality control for urine sediment RBC, WBC, Epithelial Cell, CAST, and Bacteria during July to December 2022. Apply the EZ rules 3 quality control software to assess whether the results of internal quality control meet the quality control requirements. Using three times the coefficient of variation (CV%) results from the CAP survey relative to the concentration of urine quality control as the Total Error allowable (TEa). Appropriately adjusting TEa and comparing the impact of different TEa values on internal quality control of urine sediment RBC, WBC, Epithelial Cell, CAST, and Bacteria, including the σ values, selection of quality control rules, frequency of quality control, and the performance of P_(ed) and P_(fr). Results: Calculate TEa for each item by multiplying three times the CV% results from the CAP survey relative to the concentration of urine quality control. The TEa values for RBC, WBC, Epithelial Cell, CAST, and Bacteria are 40%, 40%, 120%, 160%, and 40% respectively. The TEa values are appropriately reduced as follows: (1) Quality control level I: Epithelial Cell is reduced to 80%, and CAST is reduced to 107%; (2) Quality control level II: RBC is reduced to 20%, WBC is reduced to 20%, Epithelial Cell is reduced to 40%, CAST is reduced to 80%, and Bacteria is reduced to 27%. The changes in σ values after adjusting TEa are as follows: For Level I, Epithelial Cell decreased from 12.2 to 6, and CAST decreased from 8.7 to 5.7. For Level II, RBC decreased from 12.1 to 6, WBC decreased from 15.9 to 7.9, Epithelial Cell decreased from 22.1 to 7.1, CAST decreased from 15.8 to 7.8, and Bacteria decreased from 8.3 to 5.4. Before adjustment, several σ values were >6, resulting in low P_(ed) and P_(fr), making it ineffective to monitor the performance of internal quality control. After appropriately reducing the TEa values, the above items can maintain P_(ed) > 90% and P_(fr) < 5%, meeting the requirement of 2 quality control runs. Conclusion: Monitoring the performance of internal quality control using three times the coefficient of variation (CV%) results from the CAP survey relative to the concentration of urine quality control as TEa may not be entirely appropriate. This could potentially result in higher σ values, leading to a decrease in P_(ed) and P_(fr). After appropriately reducing the TEa values, more suitable conditions for internal quality control monitoring can be established. It is possible to effectively reduce the previously high σ values of each item, and maintain P_(ed) > 90% and P_(fr) < 5%, meeting the requirement of 2 quality control runs. This study can provide a reference for domestic laboratories in selecting quantitative analysis for quality control rules in urine sediment examination.