尿酸品質改進與參考值評估之研究

臨床檢驗室品質管理的最高目標，就是檢驗報告的品質保證。臨床檢驗常因分析前、分析中、分析後的錯誤而降低結果的可靠性。不同的錯誤其評估的步驟與處理的方法並無準則可遵循。在國內大多數臨床實驗室的檢驗參考值，都是直接採用廠商隨機所附的參考值，本科臨床生化檢驗室在此次汰換更新大型自動分析儀器時，十七項檢驗參考值中只有尿酸參考值由3.5～7.9 mg/dL改變為3.4～7.0 mg/dL，導致病人的血清尿酸檢驗高尿酸的此率由2.8%（193/6896）增加為16.7%（1151/6896），與臨床症狀及徵候並不符合，影響醫師數據判讀與臨床處置。本研究建立評估錯誤原因之步驟與品質改進之方法，包括精確度、準確度、實驗室內部品管、proficiency testing、兩儀器間相關性、分析前及分析後的錯誤等各項評估結果，證實病人高尿酸的比率增加並非由實驗室分析錯誤所導致。經由分析508人（男性258人，女性250人）建立本院尿酸檢驗之參考值，男性為3.4～8.2 mg/dL（5.8 ± 1.21），女性為2.8～7.4 mg/dL（5.1 ± 1.17），不分性別為3.2～8.0 mg/dL（5.6 ± 1.19），高尿酸的比率修正為3.0%（537/17909），證實因循直接採用儀器隨附之參考值是錯誤的決策。此篇研究結果顯示，臨床檢驗室在更換儀器，都應適時修正其參考值，並且建立自己實驗室尿酸檢驗參考值。

關鍵字

品質保證；尿酸分析；參考值

並列摘要

Quality assurance for each individual report is the ultimate goal of the quality control in a clinical diagnostic laboratory. Every mistake from application to report distribution will possibly disturb the reliability of the clinical diagnosis. There is however lack of standard rules to evaluate and manage the various errors happened in different laboratories. We encountered unexpected deviation of high uric acid analysis, while the reference range was altered from 3.5 ~ 7.9 mg/dL to 3.4 ~ 7.0 mg/dL according to the manufacturer's recommendation for the newly installed automatic biochemistry analyzer. The ratio of analysts with abnormal high uric unreasonably increased from 2.8% (193/6896) to 16.7% (1151/6896). Quality control of the uric acid analysis was queried by clinicians. But we found no defect in analysis itself after logically evaluating all possible errors in several aspects and systematically implanting several quality improvement trials. Alternation of the uric acid reference range was then proved to be the whence. After analyzing 258 males and 250 females randomly, we suggested reference ranges of uric acid 3.4 ~ 8.2 (5.8 ± 1.21) mg/dL and 2.8 ~ 7.4 (5.1 ± 1.17) mg/dL for men and women, respectively. The ratio for reporting abnormal high uric acid diminished to 3.0% (537/17090) through adapting these self-defined reference range instead. This result implicated the inappropriateness of complying with any reference range without investigation.

並列關鍵字

quality assurance ； uric acid ； reference range

國際替代計量

尿酸品質改進與參考值評估之研究

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