文章詳目資料
藥物食品檢驗局調查研究年報
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中文摘要
本計畫係針對不同pH値對於尿液中甲基安非他命及鴉片類藥物之檢驗用 免疫學分析套組所可能產生之影響進行評估，俾爲尿液檢體初步檢命之參考。 本計畫所評估之免疫學分析套組包括：AbuSignTM，TDxR&EmitR d.a.u.TM 三種。評估結果顯示，㈠尿液pH値改變及摻加明礬對TDxR無影響。㈡對 AbuSign™套組，pH値變化對嗎啡測試無影響，對甲基安非他命濃度爲600ng/ ml及3000ng/ml之尿液，pH値爲2.0時，呈偽陰性反應，甲基安非他命濃度爲 600ng/ml，pH値爲4.0及大於10.0時，無明顯反應。㈢對EmitR d.a.u.TM於甲 基安非化命濃度爲600 ng/ml，pH値低於6.0以下時，呈偽陰性反應。㈣對 AbuSign™套組，明礬濃度2.5%以上時，對甲基安非他命及嗎啡均無法測試， 明礬濃度爲1.0%時，對嗎啡仍呈陽性反應，對甲基安非他命濃度爲600 ng/ml 時，則呈偽陰性反應；對甲基安非他命濃度爲3000 ng/ml時，反應線不明顯。 ㈤對EmitR d.a.uTM明礬濃度高於5.0%以上，對甲基安非他命及嗎啡均呈偽陰 性反應，明礬濃度爲2.5%時，只對甲基安非他命濃度爲600 ng/ml時，呈偽陰 性反應，明礬濃度爲1.0%時，對嗎啡及甲基安非他命測試均無影響。㈥添加 明礬對TDXR％’則試不致呈偽陰性反應。
英文摘要
TDxr, EmitR d.a.u.™ and AbuSign ™ commerically available kits for methamphetami ne and opiate assays were evaluated for the effects of pH of urine and the addition of alum. Assays were tested at pH 2.0，4.0，6.0, 8.0, 10.0，12.0 and 1.0，2.5，5.0，7.5% of alum, in urine. Results indicate that pH changes of urine have no effect on TDxr. False negative results ocurred at pH out of range 6.0-8.0 for AbuSign™ and pH lower than 6.0 for EmitR d.a.u.™ when methamphetamine concentration is 600 ng/ml. At pH 2.0 and methamphetami ne at a concentration of 600, 3000 ng/ml, false negative results were observed with AbuSign™ kit. While different concentrations of alum in urine have no effect on TDxR immunoasays, nevertheless it exhibited significant infulence on AbuSign™ and EmitR assays as well.