AS/NZS 4760:2019
Procedure for specimen collection and the detection and quantification of drugs in oral fluid
Ensures that the detection of drugs in oral fluid meets the expectations for testing of specimens for applications such as workplace, medico-legal, or court-directed purposes. This standard is not intended for clinical use or for drug exposure detection in sport, but it may be used if deemed relevant. This standard addresses procedures for the collection of oral fluid, on-site drug testing, handling and dispatch of specimens to the laboratory for screening tests (if applicable) and confirmatory testing.
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AS/NZS 4760:2019 PROCEDURE FOR SPECIMEN COLLECTION AND THE DETECTION AND QUANTIFICATION OF DRUGS IN ORAL FLUID
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE AND APPLICATION
1.1.1 Scope
1.1.2 Application
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.3.1 Adulteration
1.3.2 Amphetamine-type substances (Sympathomimetic amines)
1.3.3 Batch
1.3.4 Benzodiazepines
1.3.5 Blind testing
1.3.6 Calibration sample
1.3.7 Cannabinoids
1.3.8 Chain-of-custody
1.3.9 Chain-of-custody form
1.3.10 Cocaine and metabolites
1.3.11 Collection device
1.3.12 Collection facility
1.3.13 Collection site
1.3.14 Collector
1.3.15 Concentration
1.3.16 Confirmatory test
1.3.17 Confirmed positive result
1.3.18 Control specimen
1.3.19 Cut-off concentration
1.3.20 Donor
1.3.21 Drug
1.3.22 Drug-free specimen
1.3.23 Expert
1.3.24 Fit-for-purpose
1.3.25 Laboratory
1.3.26 Laboratory analyst
1.3.27 Laboratory record system
1.3.28 Laboratory specimen
1.3.29 Limit of detection (LOD)
1.3.30 Limit of reporting (LOR)
1.3.31 Negative result
1.3.32 Not-negative (unconfirmed) result
1.3.33 On-site
1.3.34 On-site screening test device
1.3.35 On-site testing
1.3.36 Opioids
1.3.37 Oral fluid specimen
1.3.38 Permanent record system
1.3.39 Proficiency testing program
1.3.40 Quality control
1.3.41 Referee specimen
1.3.42 Requesting authority
1.3.43 Sample
1.3.44 Screening test
1.3.45 Specimen dilution
1.3.46 Transportation device
1.3.47 Uncertainty of measurement
1.3.48 Verification of devices
SECTION 2 COLLECTION, STORAGE, HANDLING AND DISPATCH
2.1 GENERAL
2.2 COLLECTION SITE
2.2.1 General
2.2.2 Privacy
2.2.3 Security
2.2.4 Informed consent
2.2.5 Chain-of-custody
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 AND GENERAL ACCEPTANCE CRITERIA
3.6 RECONCILIATION OF TEST RESULTS
3.7 STORAGE OF SPECIMEN
3.7.1 Short-term storage
3.7.2 Long-term storage
SECTION 4 LABORATORY SCREEN TESTING
4.1 GENERAL
4.2 METHOD
4.3 LABORATORY SECURITY, SPECIMEN RECEPTION AND STORAGE OF SPECIMENS
4.4 RESPONSIBILITIES AND PERSONNEL
4.4.1 Laboratory supervision
4.4.2 Laboratory analyst
4.4.3 Analytical toxicologist
4.4.4 Acceptance of results
4.5 NUMBER OF DETERMINATIONS
4.6 CALIBRATION
4.7 BLANK DETERMINATION
4.8 QUALITY CONTROL
4.9 SCREENING TEST CUT-OFF LEVELS
4.10 ACCEPTANCE CRITERIA
4.11 INTERPRETATION OF RESULTS
4.12 REPORTING OF RESULTS
4.12.1 Conditions for reporting
4.12.2 Test report
4.13 RECORD KEEPING
SECTION 5 LABORATORY CONFIRMATORY PROCEDURES
5.1 SCOPE
5.2 PRINCIPLE
5.3 APPARATUS
5.3.1 Gas chromatograph/mass spectrometer
5.3.2 Liquid chromatograph/mass spectrometer
5.4 LABORATORY SECURITY, SPECIMEN RECEPTION AND STORAGE OF SPECIMENS
5.5 RESPONSIBILITIES AND PERSONNEL
5.5.1 Laboratory management
5.5.2 Laboratory supervision
5.5.3 Laboratory analyst
5.5.4 Acceptance of results
5.5.5 Review results
5.6 CONFIRMATORY PROCEDURES
5.7 INSTRUMENTATION
5.8 NUMBER OF DETERMINATIONS
5.9 INSTRUMENT SETUP
5.10 BLANK DETERMINATION
5.11 QUALITY CONTROL
5.12 CALCULATIONS
5.13 UNCERTAINTY OF MEASUREMENT
5.14 ACCEPTANCE CRITERIA
5.15 TEST REPORT
5.16 RECORD KEEPING
5.17 DISPUTED RESULTS
APPENDIX A - ON-SITE SCREENING TEST PROCEDURE
A1 GENERAL
A2 PERSONNEL
A3 PROCEDURE
A3.1 General
A3.2 Requirements for on-site drug testing
A3.3 Requirements for quality control and quality assurance, including proficiency testing
A4 REPORTING OF RESULTS
A4.1 General
A4.2 Conditions for reporting
A4.3 Test report
A4.4 Record keeping
A4.5 Reconciliation of test results
APPENDIX B - ADDITIONAL TESTING
APPENDIX C - VERIFICATION OF PERFORMANCE OF DEVICES USED FOR THE COLLECTION, ON-SITE TESTING, TRANSPORT AND STORAGE OF...
C1 GENERAL
C2 COLLECTION DEVICES
C3 ON-SITE TESTING DEVICES
C4 TRANSPORTATION AND STORAGE DEVICES
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 IMMUNOASSAY (IA)
E2 GAS CHROMATOGRAPHY (GC)
E3 GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS)
E4 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC or LC)
E5 LIQUID CHROMATOGRAPHY/MASS SPECTROMETRY (LC/MS)
E6 TANDEM MASS SPECTROMETRY(GC/MS/MS, LC/MS/MS)
E7 HIGH RESOLUTION AND ACCURATE MASS SPECTROMETRY
Amendments
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AS/NZS 4760:2019 PROCEDURE FOR SPECIMEN COLLECTION AND THE DETECTION AND QUANTIFICATION OF DRUGS IN ORAL FLUID
PREFACE
CONTENTS
FOREWORD
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE AND APPLICATION
1.1.1 Scope
1.1.2 Application
1.2 REFERENCED DOCUMENTS
1.3 DEFINITIONS
1.3.1 Adulteration
1.3.2 Amphetamine-type substances (Sympathomimetic amines)
1.3.3 Batch
1.3.4 Benzodiazepines
1.3.5 Blind testing
1.3.6 Calibration sample
1.3.7 Cannabinoids
1.3.8 Chain-of-custody
1.3.9 Chain-of-custody form
1.3.10 Cocaine and metabolites
1.3.11 Collection device
1.3.12 Collection facility
1.3.13 Collection site
1.3.14 Collector
1.3.15 Concentration
1.3.16 Confirmatory test
1.3.17 Confirmed positive result
1.3.18 Control specimen
1.3.19 Cut-off concentration
1.3.20 Donor
1.3.21 Drug
1.3.22 Drug-free specimen
1.3.23 Expert
1.3.24 Fit-for-purpose
1.3.25 Laboratory
1.3.26 Laboratory analyst
1.3.27 Laboratory record system
1.3.28 Laboratory specimen
1.3.29 Limit of detection (LOD)
1.3.30 Limit of reporting (LOR)
1.3.31 Negative result
1.3.32 Not-negative (unconfirmed) result
1.3.33 On-site
1.3.34 On-site screening test device
1.3.35 On-site testing
1.3.36 Opioids
1.3.37 Oral fluid specimen
1.3.38 Permanent record system
1.3.39 Proficiency testing program
1.3.40 Quality control
1.3.41 Referee specimen
1.3.42 Requesting authority
1.3.43 Sample
1.3.44 Screening test
1.3.45 Specimen dilution
1.3.46 Transportation device
1.3.47 Uncertainty of measurement
1.3.48 Verification of devices
SECTION 2 COLLECTION, STORAGE, HANDLING AND DISPATCH
2.1 GENERAL
2.2 COLLECTION SITE
2.2.1 General
2.2.2 Privacy
2.2.3 Security
2.2.4 Informed consent
2.2.5 Chain-of-custody
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 AND GENERAL ACCEPTANCE CRITERIA
3.6 RECONCILIATION OF TEST RESULTS
3.7 STORAGE OF SPECIMEN
3.7.1 Short-term storage
3.7.2 Long-term storage
SECTION 4 LABORATORY SCREEN TESTING
4.1 GENERAL
4.2 METHOD
4.3 LABORATORY SECURITY, SPECIMEN RECEPTION AND STORAGE OF SPECIMENS
4.4 RESPONSIBILITIES AND PERSONNEL
4.4.1 Laboratory supervision
4.4.2 Laboratory analyst
4.4.3 Analytical toxicologist
4.4.4 Acceptance of results
4.5 NUMBER OF DETERMINATIONS
4.6 CALIBRATION
4.7 BLANK DETERMINATION
4.8 QUALITY CONTROL
4.9 SCREENING TEST CUT-OFF LEVELS
4.10 ACCEPTANCE CRITERIA
4.11 INTERPRETATION OF RESULTS
4.12 REPORTING OF RESULTS
4.12.1 Conditions for reporting
4.12.2 Test report
4.13 RECORD KEEPING
SECTION 5 LABORATORY CONFIRMATORY PROCEDURES
5.1 SCOPE
5.2 PRINCIPLE
5.3 APPARATUS
5.3.1 Gas chromatograph/mass spectrometer
5.3.2 Liquid chromatograph/mass spectrometer
5.4 LABORATORY SECURITY, SPECIMEN RECEPTION AND STORAGE OF SPECIMENS
5.5 RESPONSIBILITIES AND PERSONNEL
5.5.1 Laboratory management
5.5.2 Laboratory supervision
5.5.3 Laboratory analyst
5.5.4 Acceptance of results
5.5.5 Review results
5.6 CONFIRMATORY PROCEDURES
5.7 INSTRUMENTATION
5.8 NUMBER OF DETERMINATIONS
5.9 INSTRUMENT SETUP
5.10 BLANK DETERMINATION
5.11 QUALITY CONTROL
5.12 CALCULATIONS
5.13 UNCERTAINTY OF MEASUREMENT
5.14 ACCEPTANCE CRITERIA
5.15 TEST REPORT
5.16 RECORD KEEPING
5.17 DISPUTED RESULTS
APPENDIX A - ON-SITE SCREENING TEST PROCEDURE
A1 GENERAL
A2 PERSONNEL
A3 PROCEDURE
A3.1 General
A3.2 Requirements for on-site drug testing
A3.3 Requirements for quality control and quality assurance, including proficiency testing
A4 REPORTING OF RESULTS
A4.1 General
A4.2 Conditions for reporting
A4.3 Test report
A4.4 Record keeping
A4.5 Reconciliation of test results
APPENDIX B - ADDITIONAL TESTING
APPENDIX C - VERIFICATION OF PERFORMANCE OF DEVICES USED FOR THE COLLECTION, ON-SITE TESTING, TRANSPORT AND STORAGE OF...
C1 GENERAL
C2 COLLECTION DEVICES
C3 ON-SITE TESTING DEVICES
C4 TRANSPORTATION AND STORAGE DEVICES
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 IMMUNOASSAY (IA)
E2 GAS CHROMATOGRAPHY (GC)
E3 GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS)
E4 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC or LC)
E5 LIQUID CHROMATOGRAPHY/MASS SPECTROMETRY (LC/MS)
E6 TANDEM MASS SPECTROMETRY(GC/MS/MS, LC/MS/MS)
E7 HIGH RESOLUTION AND ACCURATE MASS SPECTROMETRY
Amendments
AS/NZS 4760:2019
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.