台灣地區勞工醫院如何建立檢驗方法之評估

How to Establish the Method Evaluation for Test Method in Labor Hospitals

商弘昇(Hung-Sheng Shang)；利琇美(Shiu-Mei Li)；黃正一(Zheng-Yi Huang)；陳清梅(Ching-Mei Chen)；張錦標(Jin-Biou Chang)

實驗室認證 ； 方法評估 ； 檢驗品質 ； Laboratory accreditation ； method evaluation ； laboratory assay quality

中華職業醫學雜誌

20卷4期（2013 / 12 / 01）

245 - 251

繁體中文

檢驗方法評估就是檢驗誤差的評估與判斷，評估是否能符合規格要求或使用需求，以確保分析方法的可靠性。醫學實驗室認證機構之規範是檢驗品質最基本之要求，檢驗方法評估為實驗室認證所要求。檢驗室在檢驗前，應對檢驗分析方法先行評估，選擇適當的方法再使用，對整體品管系統有其重要性的影響。分析項目依分析方法與原理之不同，可適當選擇下列評估包括：精確度、準確度、線性、回收試驗、干擾、方法比較、偵測範圍、生物參考區間確認等。實驗室應制定方法評估之程序，確保分析結果之可靠性，以提升臨床醫療品質與檢驗品質。

To evaluate a test method is the evaluation and judgment process of its errors. To assure the reliability of the test method, a process is needed to evaluate a test method if it meets the manufacture's specification or users' requirements. The norm from accreditation body is a basic requirement for medical laboratories. A test method is supposed to be evaluated by laboratory accreditation requirements. A laboratory has to evaluate the test method before its implementation. It is very important to whole quality system to select a suitable method. A variety of evaluation methods can be selected depending on the methods and principles of test items, including precision, accuracy, linearity test, recovery test, interference effects, comparison test, analytic measurement range, reference interval validation and etc. A laboratory has to establish a documented procedure validating test methods to assure reliability of its test results and consequent improvements of clinical treatment quality and laboratory assay quality.