目的：在某次的外部能力試驗AFP(α-fetoprotein)項目的評比結果不合格，經調查原因為試劑組運送過程的溫度過高，導致試劑不穩定而造成檢驗結果的不準確。本研究主要評估試劑組的運送溫度對檢測結果之影響，及建立放射免疫分析試劑運送、接收及驗收之準則。
方法：(1)統計近6個月實驗室內部品管的CV%結果，(2)外部品管(RIQAS)近3次評比結果，(3)實際
評估：當試劑套裝組運送至實驗室時，使用遠紅外線溫度計測量試劑簽收時的溫度並加以紀錄。採用外部及內部品管之檢體，由同一人進行操作分析，在相同的操作環境下，使用不同批號的AFP試劑組，共測試了3個批號的試劑套裝組。
結果：(1)內部品管control 1、 control 2及control 3的CV平均值，分別為5.8%、5.7%、6.0%，(2)外部品管(RIQAS)之評比結果都可接受，(3)無論外部或內部品管檢體，運送溫度符合要求(2-8℃)之試劑批號360A(7℃)，其檢測值均明顯較運送溫度不符合要求(≧16℃)的試劑(359A及358A)為低。
結論：AFP試劑在較高的温度運送，其分析結果明顯高於溫度較低之試劑，顯示試劑運送過程的溫度確實會影響分析結果。實驗室管理階層應建立RIA試劑運送與接收及驗收之標準作業流程，以提升檢驗分析之品質。

Purpose: Various factors will mislead the result of laboratory examinations. One of the proficienttests of the α-fetoprotein (AFP) was failed. After excluding all the possible potential errorsfrom human operation, we highly suspected this failure is caused because of the temperaturechanges during the transfer process. In this study, we want to explore the effect of the laboratorystudy of the radio-immunoassay (RIA) kit during the transportation. Furthermore, we would alsolike to establish the standard procedure of RIA kits in the transportation, reception, and acceptance.
Methods: (1) Collection and analysis the CV% of the laboratory quality control result in recent6 months. (2) Recent 3 times of the results of proficient tests (RIQAS). (3) A far-infrared thermometerwas applied in the reception procedure of RIA kits. Three lot numbers of AFP kits were acquired;the RIA studies were performed by a well-trained senior operator. Specimens were acquiredfrom the internal and external control kit, and all the operation environments were maintainedas the same.
Results: (1) Average CV results of the internal control 1, 2, and 3 were 5.8%, 5.7%, and 6.0%,respectively. (2) The result of RIQAS study was within the acceptable range. (3) The receptiontemperature of lot No. 360A was 7°C; this is in accordance with the acceptance standard of theRIA kits (2°C -8°C). The other two kits, lot No. 359A and 358A, were higher than 16°C. We foundthat the result from the lot No. 360A was significantly lower than those from the 359A and 358A.
Conclusion: For AFP kits in a higher temperature during transportation, the result of RIA testwere higher than that kept under the acceptable temperature. For a good RIA laboratory, standardoperatory procedures for RIA kits transfer, receiving, and acceptation should be established andmonitored.