Standard
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AS/NZS 4308:2023
[Current]Procedures for specimen collection and the detection and quantification of drugs in urine
AS/NZS 4308:2023 sets out procedures for urine specimen collection, storage, handling, onsite drug screening tests and, if required, dispatch to a laboratory. It also covers applicability of urine for drug testing and general issues related to drug screening onsite and drug screening or confirmation in a laboratory.
Published: 10/11/2023
Pages: 46
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Introduction
1 Scope and general
1.1 Scope
1.2 Application
1.2.1 Drug analysis
1.2.2 Transitional period
1.3 Normative references
1.4 Terms and definitions
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
2.3.3.1 General
2.3.3.2 Specimen screening
2.4 Preparation for dispatch
2.5 Transportation to the laboratory
3 Onsite screening test procedure
3.1 General
3.2 Access to expertise
3.3 Procedure
3.3.1 General
3.3.2 Requirements for onsite screening tests
3.3.3 Requirements for quality control and proficiency testing
3.3.3.1 Quality control
3.3.3.2 Proficiency testing
3.4 Reporting of results
3.4.1 General
3.4.2 Conditions for reporting
3.4.3 Test report
3.4.4 Record keeping
3.4.5 Collation and reconciliation of test results
4 General laboratory requirements
4.1 General
4.2 Reagents
4.3 Apparatus
4.3.1 Volumetric glassware
4.3.2 Piston-operated volumetric apparatus
4.4 Laboratory security
4.5 Specimen reception and general acceptance criteria
4.5.1 Reception of specimens
4.5.2 General acceptance criteria
4.6 Specimen integrity testing
4.6.1 General
4.6.2 Creatinine concentration equal to or greater than 50 mg/L but less than 200 mg/L
4.6.3 Creatinine less than 50 mg/L
4.6.4 Other substances
4.7 Collation and reconciliation of test results
4.8 Storage of specimens
4.8.1 Short-term storage
4.8.2 Long-term storage
5 Laboratory screening procedures
5.1 General
5.2 Method
5.3 Laboratory personnel
5.3.1 Laboratory manager
5.3.2 Laboratory supervisor
5.3.3 Laboratory analyst
5.3.4 Access to expertise
5.3.5 Acceptance of results
5.3.6 Review of results
5.4 Number of determinations
5.5 Calibration
5.6 Blank determination
5.7 Quality control
5.8 Screening test cut-off levels
5.9 Acceptance criteria
5.10 Interpretation of results
5.11 Reporting of results
5.11.1 Conditions for reporting
5.11.2 Test report
5.12 Record keeping
6 Laboratory confirmatory procedures
6.1 General
6.2 Principle
6.3 Apparatus
6.4 Laboratory personnel
6.4.1 Laboratory manager
6.4.2 Laboratory supervisor
6.4.3 Laboratory analyst
6.4.4 Access to expertise
6.4.5 Acceptance of results
6.4.6 Review results
6.5 Confirmation procedures
6.6 Instrumentation
6.7 Number of determinations
6.8 Instrument setup
6.9 Blank determination
6.10 Quality control
6.11 Calculations
6.12 Interpretation of results
6.13 Acceptance criteria
6.13.1 General
6.13.2 Mass spectrometric detection
6.13.2.1 General
6.13.2.2 Selected ion monitoring mode
6.13.2.3 Tandem mass spectrometry
6.13.2.4 High resolution (accurate mass measurement) mass spectrometry
6.14 Test report
6.15 Record keeping
6.16 Disputed results
Appendix A
A.1 General
A.2 Immunoassay testing for optional drugs
A.3 Mass spectrometry testing for optional drugs
A.4 Testing for additional drugs
Appendix B
B.1 General
B.2 Collection, transportation and storage devices
B.3 Onsite creatinine testing devices
B.4 Onsite drug screening devices
Appendix C
C.1 General recommendations
C.2 Disinfection of spills
C.3 Disinfection of equipment
C.4 Waste disposal
Appendix D
D.1 Immunoassay
D.2 Gas chromatography
D.3 Gas chromatography/mass spectrometry
D.4 High performance liquid chromatography
D.5 Liquid chromatography/mass spectrometry
D.6 Tandem mass spectrometry
D.7 High resolution and accurate mass spectrometry
Appendix E
E.1 Laboratory manager
E.2 Laboratory supervisor
E.3 Laboratory analyst
E.4 Expert
Bibliography
Cited references in this standard
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