Urine test is classified into initial test and confirmatory test.

The testing institution shall access the urine specimens into several lots and test them lot by lot, and the quantity of each lot shall be determined in respect of the testing method. Every lot of specimens for initial or confirmatory test shall include proper quantity of quality control urine and blind quality control urine, and shall be tested as common urine specimens.

The sources of the standard and quality control urine used by the testing institution shall be recorded and the content, date of production and validity period shall be marked.

The testing institution shall prepare a quality manual to prescribe all the standard operation procedures for laboratory operations, and the contents shall at least include the following items:
1. Chain of custody procedures;
2. Storage and withdrawal for use of specimens;
3. Analytical methods and procedures:
(1) Principle of each drug test.
(2) Methods to prepare reagent, standard and quality control urine.
(3) Testing methods and calibration procedures.
(4) Principle for judgment of testing result.
(5) Sensitivity, linear range, limit of detection, and limit of qauntification, of the testing method.
4. Quality management and quality assurance.
5. Measures for correction and prevention of system abnormity.
6. List of testing equipments and maintenance plan.
7. Employee training.
8. Procedures of producing test report and format of report.
9. Computer, software and laboratory information management system.
10. Using quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review to improve the effectiveness of management system continually.

The specimen shall be judged as positive if the initial test results indicate the concentration of drug or drug metabolite in the urine specimen not lower than the following cutoff values:
1. Amphetamines: 500 ng/mL.
2. Opiate metabolites: 300 ng/mL.
3. Marijuana metabolites: 50 ng/mL.
4. Cocaine metabolites: 300 ng/mL.
5. Ketamine metabolites: 100 ng/mL.
For the initial test results of abused drugs or their metabolites other than listed in the preceding paragraph, the cutoff values shall be determined according to the concentration as announced by the Taiwan Food and Drug Administration, Ministry of Health and Welfare. In absence of the announced concentration, the cutoff values may be determined by the testing institution based on the limit of quantification using its methods of analysis.

Where the initial test results are lower than the cutoff values set forth in the preceding Article, the urine specimen shall be judged as negative; and the residual specimen shall be disposed in accordance with the provision of article 9.

The testing institution may use two or more initial test methods to test a same kind of abused drug, and shall observe the provisions set forth in these Regulations.

Where the initial test results are not lower than the cutoff values or any doubt arises about the test result of the urine specimen, the confirmatory test shall be performed. If the test results are not lower than the following cutoff values, the specimen shall be judged as positive:
1. Amphetamines:
(1) Amphetamine: 500 ng/mL.
(2) Methamphetamine: Methamphetamine 500 ng/mL, and its metabolite amphetamine not less than 100 ng/mL.
(3) 3,4-Methylenedioxymethamphetamine (MDMA): 500 ng/mL. If both MDMA and MDA are found and the concentration of each is lower than 500ng/mL, but the total concentration is not lower than 500 ng/mL, the specimen shall also be judged as MDMA positive.
(4) 3,4-Methylenedioxyamphetamine (MDA): 500 ng/mL.
(5) 3,4-Methylenedioxyethylamphetamine (MDEA): 500 ng/mL.
2. Opiates:
(1) Morphine: 300 ng/mL.
(2) Codeine: 300 ng/mL.
3. Marijuana metabolite (Delta-9-tetrahydrocannabinol-9-carboxylic acid): 15 ng/mL.
4. Cocaine metabolite (Benzoylecgonine): 150 ng/mL.
5. Ketamine metabolites:
(1) Ketamine: 100 ng/mL. If both Ketamine and Norketamine are found and the concentration of each is lower than 100 ng/mL, but the total concentration is not lower than 100 ng/mL, the specimen shall also be judged as Ketamine positive.
(2) Norketamine: 100 ng/mL.
For the abused drugs other than listed in the preceding paragraph or other metabolites, the cutoff values shall be determined according to the concentration as announced by the Taiwan Food and Drug Administration, Ministry of Health and Welfare. In absence of the announced concentration, the cutoff values may be determined by the testing institution based on the limit of quantification using its methods of analysis.

Where the confirmatory test results are lower than the limit of quantification set forth in the preceding Article, the urine specimen shall be judged as negative; and the residual specimen shall be disposed in accordance with the provision of article 9.

For the drug abuse urine used for juridical cases, the limits of quantification may be used as cutoff values where necessary, without being limited by the provisions of Articles 15 and 18.

The test report shall be produced by the testing institution in writing or electronic format with anti-counterfeiting design.

Where necessary, the test consignor may request the testing institution to provide original test records or test results.

If the test consignor doesn't agree with the result of urine test, it may explain the reasons to request retest within fourteen days following receipt of test report.

The limit of quantification of abused drugs or their metabolites tested by the testing institution shall be used as the basis of the cutoff values for retest of urine specimens. Where the retest result are lower than the limit of quantification, the specimen shall be judged as negative; where not lower than the limit of quantification, positive.