精簡螢光檢測器搭配序列式注射系統用於臨床用鄰苯二甲醛消毒劑之濃度測定

Abstract

鄰苯二甲醛(o-phthalaladehyde)是一種臨床用於次重要醫療器材(semi-critical medical devices)且原濃度為0.55%之消毒劑，會隨著使用次數與存放時間衰減，其有效消毒濃度範圍介於 0.3%~0.55%，現行鄰苯二甲醛消毒劑濃度檢測方法大多利用化學試片以半定量判斷消毒劑濃度是否還在有效消毒範圍，此方法準確度低、檢測成本高、操作步驟繁雜，因此使用意願低而使得消毒劑管制效率不佳。本研究為改善上述缺陷，因此使用圖形化程式設計軟體(Labview 2014)完成自動化程序控制搭配自製精簡化螢光檢測器進行螢光強度檢測後將輸出訊號回傳至電腦利用Labview 2014程式進行數據讀取，開發一用於鄰苯二甲醛消毒劑濃度測定之高度自動化可攜式螢光檢測系統。 自動化程序包括多通道閥門與注射幫浦控制，利用自動化系統進行混合稀釋程序改善因手動化學實驗所造成之人為操作誤差，藉此提高檢測準確度、重複性及再現性；自製精簡化螢光檢測器則是將自製流動式系統、光學檢測電子電路、3D列印檢測器外殼分別製作完成後進行系統整合所製成。 先前實驗利用自動化流道系統搭配螢光檢測儀器(FP-1520)完成預稀釋30倍之0.25%~0.55%臨床用鄰苯二甲醛濃度測定，並且證明此系統具有高線性趨勢(R2≧0.99)、高重複性(RSD<±5%)、高再現性(RSD<±5%)等優勢；為改善螢光檢測儀器體積過於龐大及因光電倍增管感測靈敏度過高而需減弱輸出訊號使檢測敏感度降低之問題，因此本研究後續利用自製精簡化螢光檢測器取而代之，仍保有優良線性趨勢(R square≒0.965)及重複性(RSD<±5%)同時達到高檢測敏感度、高訊噪比、體積微小化、低儀器成本等效果，可應用於稀釋30倍之臨床用鄰苯二甲醛消毒劑濃度測定。

O-phthalaladehyde is a disinfectant used in the clinic for semi-critical medical equipment with an initial concentration of 0.55%. It will decay with the number of uses and storage time and is detected by chemical strips nowadays. However, the detection results of chemical test strips based on a semi-quantitative way decreased willingness to use test strips due to the low accuracy, expensive and complicated operation steps of this method, and reduced the efficiency of disinfectant control. We developed a Sequential Injection system with a compact fluorescence detector to determine whether o-phthalaldehyde is used as a disinfectant in the clinic. Automated procedures include multi-channel valve and syringe pump control and the use of automatic systems for mixing and dilution procedures to improve errors caused by manual chemical experiments, thereby improving detection accuracy, repeatability, and reproducibility and the self-made compact fluorescence detector integrated with the self-made flow system, optical detection electronic circuit, and 3D printed detection cell into a system. The pilot research used a fluorescence detection instrument (FP-1520) to complete the 30-fold pre-diluted 0.25%~0.55% Cidex OPA(Johnson & Johnson ,USA) determination. It proved this system has a fine linear correlation (R square≧0.99 ), repeatability (RSD<±5%), and reproducibility (RSD<±5%). To miniaturize the volume of the fluorescence detection instrument and optimize detection performance. Therefore, we developed a self-made simplified fluorescence detector to replace the instrument, which still maintained had a good linear correlation (R square≒0.965) and repeatability (RSD<±5%) while achieving well detection sensitivity, fine signal-to-noise ratio, miniaturized volume, low instrument cost, which can be applied to determine the concentration of 30-fold pre-diluted clinical ortho-phthalaldehyde disinfectant.