Regulations Governing Drug Abuse Urine Testing Operations Article 3
The terms used in these Regulations are defined as follows:1. Drug abuse: means the use of the narcotics referred to in the Statute for any purpose other than medical treatment and without prescription or instruction of physicians.2. Urine specimen: means the urine used for testing. Urine specimen (A) is used for routine test, and specimen (B) for retest.3. Test consignor: means the institution that consigns the urine test.4. Custody and control form: means the log sheet recording the operations conducted during the process from the collection of the urine specimen until test in the testing institution.5. Batch: a batch means a group of test specimens being pretreated and tested at the same time.6. Initial test: means the test that uses methods with different theoretical basis from the confirmatory test so as to eliminate negative specimens.7. Confirmatory test: means the test conducted to confirm the suspected existence of specific drug or drug metabolite in the initial test results by using the analysis methods of gas or liquid chromatography mass spectrometry.8. Retest: means the confirmatory test conducted over specimen (B) to confirm again the existence of the drug or drug metabolite in the urine specimen.9. Quality control urine: means the urine specimen used to confirm whether the urine test is conducted accurately, including quality control specimen prepared by tester and blind quality control specimen prepared by quality personnel.10. Standard: means the substance or solution used to prepare quality control urine.11. Calibrator: means the urine specimen with known concentration of drugused for quantitative comparison.12. Blind performance specimen: means the specimen prepared by the test consignor to perform blind performance test.13. Cutoff value: means the concentration of drug or drug metabolite used to judge whether the specimen is negative or positive.14. Limit of quantification: means the lowest concentration enabling the instrument to confirm and quantify the drug tested.
中文原文 濫用藥物尿液檢驗作業準則第3條
本準則名詞，定義如下：
一、濫用藥物：指非以醫療為目的，在未經醫師處方或指示情況下，使用本條例所稱之毒品者。
二、尿液檢體：指用於檢驗之尿液。
尿液檢體（甲）為供作例行檢驗者，尿液檢體（乙）為供作複驗者。
三、委驗機構：指委託檢驗機構檢驗尿液檢體之機構。
四、檢體監管紀錄表：指尿液檢體從採集至檢驗機構所經歷各項作業之紀錄表。
五、批：指同時進行前處理及測試之檢體群。
六、初步檢驗：指採用與確認檢驗不同原理之方法，以剔除陰性檢體之檢驗。
七、確認檢驗：指以氣相或液相層析質譜分析方法，用於確定經初步檢驗結果疑似含有某特定藥物或代謝物之檢驗。
八、複驗：指已經確認檢驗檢體，為確定藥物或代謝物存在而再進行乙瓶之確認檢驗。
九、品管尿液：指用於檢查尿液檢驗是否準確之尿液檢體，包括檢驗人員自行製備品管檢體及品管人員製備盲品管檢體。
十、標準品：指用於製備品管尿液之物質或溶液。
十一、校正檢體：指作為定量比對使用之已知藥物濃度之尿液檢體。
十二、盲績效監測檢體：指委驗機構為執行盲績效監測所製備之檢體。
十三、閾值：指判定檢體為陰性或陽性之濫用藥物或其代謝物濃度。
十四、最低可定量濃度：指儀器可確認檢測物並定量檢測物之最低濃度。
一、濫用藥物：指非以醫療為目的，在未經醫師處方或指示情況下，使用本條例所稱之毒品者。
二、尿液檢體：指用於檢驗之尿液。
尿液檢體（甲）為供作例行檢驗者，尿液檢體（乙）為供作複驗者。
三、委驗機構：指委託檢驗機構檢驗尿液檢體之機構。
四、檢體監管紀錄表：指尿液檢體從採集至檢驗機構所經歷各項作業之紀錄表。
五、批：指同時進行前處理及測試之檢體群。
六、初步檢驗：指採用與確認檢驗不同原理之方法，以剔除陰性檢體之檢驗。
七、確認檢驗：指以氣相或液相層析質譜分析方法，用於確定經初步檢驗結果疑似含有某特定藥物或代謝物之檢驗。
八、複驗：指已經確認檢驗檢體，為確定藥物或代謝物存在而再進行乙瓶之確認檢驗。
九、品管尿液：指用於檢查尿液檢驗是否準確之尿液檢體，包括檢驗人員自行製備品管檢體及品管人員製備盲品管檢體。
十、標準品：指用於製備品管尿液之物質或溶液。
十一、校正檢體：指作為定量比對使用之已知藥物濃度之尿液檢體。
十二、盲績效監測檢體：指委驗機構為執行盲績效監測所製備之檢體。
十三、閾值：指判定檢體為陰性或陽性之濫用藥物或其代謝物濃度。
十四、最低可定量濃度：指儀器可確認檢測物並定量檢測物之最低濃度。