AS/NZS 4308:2008
Procedures for specimen collection and the detection and quantitation of drugs of abuse in urine
Ensures that the detection of drugs in urine meets the expectations for testing of specimens for medico-legal, workplace or court-directed purposes. Addresses appropriate procedures for the collection of urine, on-site screening, handling and dispatch of specimens to the laboratory for screening and confirmatory tests.
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AS/NZS 4308:2008 PROCEDURES FOR SPECIMEN COLLECTION AND THE DETECTION AND QUANTITATION OF DRUGS OF ABUSE IN URINE
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.3.1 Accreditation
1.3.2 Adulterant
1.3.3 Amphetamine type substances (Sympathomimetic amines)
1.3.4 Benzodiazepines
1.3.5 Blind testing
1.3.6 Calibration standard
1.3.7 Cannabinoids
1.3.8 Cannabis metabolite
1.3.9 Chain-of-custody
1.3.10 Chain-of-custody form
1.3.11 Cocaine metabolites
1.3.12 Collecting agency
1.3.13 Collecting site
1.3.14 Collector
1.3.15 Concentration
1.3.16 Confirmatory test
1.3.17 Control specimen
1.3.18 Cut-off concentration
1.3.19 Donor
1.3.20 Drug free
1.3.21 Integrity testing
1.3.22 Laboratory
1.3.23 On-site drug screening device
1.3.24 On-site screening
1.3.25 Opiates
1.3.26 Permanent record system
1.3.27 Proficiency testing program
1.3.28 Referee specimen
1.3.29 Reference compound
1.3.30 Requesting authority.
1.3.31 Sample
1.3.32 Screening tests
1.3.33 Specimen
1.3.34 Thermometer
1.3.35 Uncertainty of measurement
1.3.36 Verification of on-site devices
SECTION 2 SPECIMEN COLLECTION, STORAGE, HANDLING AND DISPATCH
2.1 GENERAL
2.2 COLLECTING SITE
2.2.1 General
2.2.2 Privacy
2.2.3 Security
2.2.4 Chain-of-custody
2.2.5 Access
2.3 INTEGRITY AND IDENTITY OF THE COLLECTED SPECIMEN
2.3.1 General
2.3.2 Precautions
2.3.3 Collection procedure
2.4 PREPARATION FOR DISPATCH
2.5 TRANSPORTATION TO THE LABORATORY
SECTION 3 GENERAL LABORATORY REQUIREMENTS
3.1 GENERAL
3.2 REAGENTS
3.3 APPARATUS
3.3.1 Volumetric glassware
3.3.2 Piston operated volumetric apparatus
3.4 LABORATORY SECURITY
3.5 SPECIMEN RECEPTION
3.6 SPECIMEN INTEGRITY TESTING
3.6.1 General
3.6.2 Creatinine concentration greater than 50 mg/L but less than 200 mg/L
3.6.3 Creatinine less than 50 mg/L
3.6.4 Other substances
3.7 RECONCILIATION OF TEST RESULTS
3.8 STORAGE OF SPECIMEN
3.8.1 Short-term storage
3.8.2 Long-term storage
SECTION 4 LABORATORY SCREENING PROCEDURES
4.1 GENERAL
4.2 METHOD
4.3 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS
4.4 PERSONNEL
4.4.1 Laboratory supervisor
4.4.2 Screening analyst
4.4.3 Access to expertise
4.4.4 Acceptance of results
4.4.5 Accreditation
4.5 NUMBER OF DETERMINATIONS
4.6 BLANK DETERMINATION
4.7 QUALITY CONTROL
4.8 SCREENING TEST CUT-OFF LEVELS
4.9 ACCEPTANCE CRITERIA
4.10 CONFIRMATORY TESTING
4.11 REPORTING OF RESULTS
4.11.1 Conditions for reporting
4.11.2 Test report
4.12 RECORD KEEPING
SECTION 5 LABORATORY CONFIRMATORY PROCEDURES
5.1 GENERAL
5.2 PRINCIPLE
5.3 APPARATUS
5.3.1 Gas chromatograph/mass spectrometer
5.3.2 Liquid chromatograph/mass spectrometer
5.3.3 Tandem mass spectrometry
5.4 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS
5.5 PERSONNEL
5.5.1 Laboratory management
5.5.2 Laboratory supervisor
5.5.3 Analyst
5.5.4 Review results
5.5.5 Accreditation
5.6 CONFIRMATION CRITERIA
5.7 INSTRUMENTATION
5.8 NUMBER OF DETERMINATIONS
5.9 BLANK DETERMINATION
5.10 INSTRUMENT SETUP
5.11 QUALITY CONTROL
5.12 CALCULATIONS
5.13 ACCEPTANCE CRITERIA
5.14 UNCERTAINTY OF MEASUREMENT
5.15 TEST REPORT
5.16 RECORD KEEPING
5.17 DISPUTED RESULTS
APPENDIX A - ON-SITE SCREENING PROCEDURE
A1 GENERAL
A2 PERSONNEL
A3 PROCEDURE
A3.1 General
A3.2 Requirements for on-site screening
A3.3 Acceptance of results
A4 REPORTING OF RESULTS
A4.1 Test report
A4.2 Record keeping
A4.3 RECONCILIATION OF TEST RESULTS
APPENDIX B - VERIFICATION OF PERFORMANCE OF ON-SITE DEVICES AROUND THE CUT-OFF
APPENDIX C - CHAIN-OF-CUSTODY FORM
APPENDIX D - RECOMMENDED PRECAUTIONS FOR HANDLING BIOLOGICAL SPECIMENS
D1 GENERAL RECOMMENDATIONS
D2 DISINFECTION OF SPILLS
D3 DISINFECTION OF EQUIPMENT
D4 WASTE DISPOSAL
D5 BIBLIOGRAPHY
APPENDIX E - PRINCIPLES OF OPERATION
E1 GAS CHROMATOGRAPHY
E2 GAS CHROMATOGRAPHY/MASS SPECTROMETRY
E3 HIGH PRESSURE LIQUID CHROMATOGRAPHY
E4 IMMUNOASSAY
E5 LIQUID CHROMATOGRAPHY/MASS SPECTROMETRY
E6 TANDEM MASS SPECTROMETRY(GC/MS/MS, LC/MS/MS)
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References
Safety in laboratories - Microbiological aspects and containment facilities
Related Information
Guidance for Managing Drug and Alcohol-Related Risks in Adventure Activities
Ministry: WorkSafe New Zealand
Section: How to test
Citation context:The preferred initial test for drugs is a urine test, followed up if necessary by blood testing. The urine test standard is AS/NZS4308:2008 Procedures for Specimen Collection and the Detection & Quantitation of Drugs of Abuse in Urine.
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AS/NZS 4308:2008 PROCEDURES FOR SPECIMEN COLLECTION AND THE DETECTION AND QUANTITATION OF DRUGS OF ABUSE IN URINE
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.3.1 Accreditation
1.3.2 Adulterant
1.3.3 Amphetamine type substances (Sympathomimetic amines)
1.3.4 Benzodiazepines
1.3.5 Blind testing
1.3.6 Calibration standard
1.3.7 Cannabinoids
1.3.8 Cannabis metabolite
1.3.9 Chain-of-custody
1.3.10 Chain-of-custody form
1.3.11 Cocaine metabolites
1.3.12 Collecting agency
1.3.13 Collecting site
1.3.14 Collector
1.3.15 Concentration
1.3.16 Confirmatory test
1.3.17 Control specimen
1.3.18 Cut-off concentration
1.3.19 Donor
1.3.20 Drug free
1.3.21 Integrity testing
1.3.22 Laboratory
1.3.23 On-site drug screening device
1.3.24 On-site screening
1.3.25 Opiates
1.3.26 Permanent record system
1.3.27 Proficiency testing program
1.3.28 Referee specimen
1.3.29 Reference compound
1.3.30 Requesting authority.
1.3.31 Sample
1.3.32 Screening tests
1.3.33 Specimen
1.3.34 Thermometer
1.3.35 Uncertainty of measurement
1.3.36 Verification of on-site devices
SECTION 2 SPECIMEN COLLECTION, STORAGE, HANDLING AND DISPATCH
2.1 GENERAL
2.2 COLLECTING SITE
2.2.1 General
2.2.2 Privacy
2.2.3 Security
2.2.4 Chain-of-custody
2.2.5 Access
2.3 INTEGRITY AND IDENTITY OF THE COLLECTED SPECIMEN
2.3.1 General
2.3.2 Precautions
2.3.3 Collection procedure
2.4 PREPARATION FOR DISPATCH
2.5 TRANSPORTATION TO THE LABORATORY
SECTION 3 GENERAL LABORATORY REQUIREMENTS
3.1 GENERAL
3.2 REAGENTS
3.3 APPARATUS
3.3.1 Volumetric glassware
3.3.2 Piston operated volumetric apparatus
3.4 LABORATORY SECURITY
3.5 SPECIMEN RECEPTION
3.6 SPECIMEN INTEGRITY TESTING
3.6.1 General
3.6.2 Creatinine concentration greater than 50 mg/L but less than 200 mg/L
3.6.3 Creatinine less than 50 mg/L
3.6.4 Other substances
3.7 RECONCILIATION OF TEST RESULTS
3.8 STORAGE OF SPECIMEN
3.8.1 Short-term storage
3.8.2 Long-term storage
SECTION 4 LABORATORY SCREENING PROCEDURES
4.1 GENERAL
4.2 METHOD
4.3 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS
4.4 PERSONNEL
4.4.1 Laboratory supervisor
4.4.2 Screening analyst
4.4.3 Access to expertise
4.4.4 Acceptance of results
4.4.5 Accreditation
4.5 NUMBER OF DETERMINATIONS
4.6 BLANK DETERMINATION
4.7 QUALITY CONTROL
4.8 SCREENING TEST CUT-OFF LEVELS
4.9 ACCEPTANCE CRITERIA
4.10 CONFIRMATORY TESTING
4.11 REPORTING OF RESULTS
4.11.1 Conditions for reporting
4.11.2 Test report
4.12 RECORD KEEPING
SECTION 5 LABORATORY CONFIRMATORY PROCEDURES
5.1 GENERAL
5.2 PRINCIPLE
5.3 APPARATUS
5.3.1 Gas chromatograph/mass spectrometer
5.3.2 Liquid chromatograph/mass spectrometer
5.3.3 Tandem mass spectrometry
5.4 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS
5.5 PERSONNEL
5.5.1 Laboratory management
5.5.2 Laboratory supervisor
5.5.3 Analyst
5.5.4 Review results
5.5.5 Accreditation
5.6 CONFIRMATION CRITERIA
5.7 INSTRUMENTATION
5.8 NUMBER OF DETERMINATIONS
5.9 BLANK DETERMINATION
5.10 INSTRUMENT SETUP
5.11 QUALITY CONTROL
5.12 CALCULATIONS
5.13 ACCEPTANCE CRITERIA
5.14 UNCERTAINTY OF MEASUREMENT
5.15 TEST REPORT
5.16 RECORD KEEPING
5.17 DISPUTED RESULTS
APPENDIX A - ON-SITE SCREENING PROCEDURE
A1 GENERAL
A2 PERSONNEL
A3 PROCEDURE
A3.1 General
A3.2 Requirements for on-site screening
A3.3 Acceptance of results
A4 REPORTING OF RESULTS
A4.1 Test report
A4.2 Record keeping
A4.3 RECONCILIATION OF TEST RESULTS
APPENDIX B - VERIFICATION OF PERFORMANCE OF ON-SITE DEVICES AROUND THE CUT-OFF
APPENDIX C - CHAIN-OF-CUSTODY FORM
APPENDIX D - RECOMMENDED PRECAUTIONS FOR HANDLING BIOLOGICAL SPECIMENS
D1 GENERAL RECOMMENDATIONS
D2 DISINFECTION OF SPILLS
D3 DISINFECTION OF EQUIPMENT
D4 WASTE DISPOSAL
D5 BIBLIOGRAPHY
APPENDIX E - PRINCIPLES OF OPERATION
E1 GAS CHROMATOGRAPHY
E2 GAS CHROMATOGRAPHY/MASS SPECTROMETRY
E3 HIGH PRESSURE LIQUID CHROMATOGRAPHY
E4 IMMUNOASSAY
E5 LIQUID CHROMATOGRAPHY/MASS SPECTROMETRY
E6 TANDEM MASS SPECTROMETRY(GC/MS/MS, LC/MS/MS)
Previous versions
AS/NZS 4308:2008
Online Library subscription pricing
The cost of your subscription will depend on which standards you want to access, and how many people in your organisation need to be able to access the Online Library subscription at the same time (concurrent users). During your subscription period, we are also able to make any necessary changes and ensure you are aware of any pricing changes that result. For a quote, contact our Online Library team by emailing onlinelibrary@standards.govt.nz.