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Chapter Law Content

Chapter 1 General Principles
Article 1
These Regulations are enacted pursuant to Paragraph Three, article 33-1 of Statute for Narcotics Hazard Control (hereinafter referred to as "the Statute ").
Article 2
These Regulations are applicable to all kinds of drug abuse urine testing institutions (hereinafter "testing institutions" for short) set forth in Paragraph One, article 33-1 of the Statute.
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.