AS/NZS 4760:2019 Australian Standard and New Zealand Standard for Oral Drug Test

AS/NZS 4760:2019 Australian Standard and New Zealand Standard for Oral Drug Test

Oral fluid (saliva) drug testing has become a widely used method for workplace drug screening across Australia and New Zealand. It is practical, non-invasive, and can be conducted almost anywhere on-site, without the need for a private facility or lengthened wait times.
Developed by Standards Australia and Standards New Zealand via their Joint Technical Committee (CH-039), which comprises toxicologists, forensic experts, employer associations, employee unions and pathological organisations from both nations.

The AS/NZS 4760:2019 provides a standardised framework that governs how oral fluid specimens are collected, screened, and confirmed, ensuring results are reliable and legally sound. To gain this certification, the product must be tested by an independent body in Australia to ensure the product complies fully with the standard.

The protocols for collecting and testing oral fluid for drugs, as well as its packaging and transportation to a laboratory, are thoroughly outlined. This includes the relevance of oral fluid in drug testing and addresses general concerns associated with on-site drug screening, as well as laboratory drug screening and/or confirmation.

On-site screen tests:

This requires the establishment of procedures, including quality controls, proficiency assessments, validation of collection, testing, and transportation equipment as suitable for their intended use, along with competency-based training. The Standard details how each step is to be completed.

A negative result is below the relevant cut-off concentration, and a not-negative (unconfirmed) result is a screening test result that is at or above the relevant cut-off concentration and therefore does not exclude the presence of a drug or class of drugs. A not-negative result may be reported as ‘unconfirmed’ or ‘requires further testing’.

Privacy procedures for collection and screening tests of oral fluid specimens should allow for individual privacy. Collection shall be witnessed by the collector, and security procedures should be in place for specimens that require laboratory testing to ensure the integrity of the specimens whilst stored onsite and during transportation.

Collection and testing should be conducted only after the donor signs a written informed consent form. This form may be either a document separate from the chain-of-custody form or a component of the chain-of-custody form.
Chain-of-custody forms shall be completed by the collector and donor.
Collection, handling, including preparation, and transportation of oral fluid specimens from one individual or place to another shall always be accomplished through chain-of-custody procedures.
To ensure the collection of pure oral fluid specimens and the accurate identification of the donor, it is essential that both the donor and the collector observe the collection process at all times, as well as any screening tests, until the labelling and sealing of the specimen(s) is finalized.
Confirmatory testing of a not-negative or unconfirmed result is performed in a laboratory using a validated and appropriate mass spectrometry method.

Laboratory Testing:

Screening tests may be conducted by immunoassay or by mass spectrometry. Confirmatory testing shall be conducted using mass spectrometry.
The screening methods applied in a laboratory are immunoassay and chromatography-based techniques. There are procedures to abide by when applying each method, and the Standard outlines these.

The laboratory will have the correct equipment and reagent grades as defined in ISO 3696. It will also have procedures for laboratory security, specimen reception and general acceptance criteria, reconciliation of test results, and storage of specimens.
This also includes calibration of each batch, quality control, and reporting of the results. Additionally, the laboratory has the responsibility of having access to a qualified and experienced expert, and supervision of the laboratory by someone with the relevant higher-level education such as a degree in the relevant field.

The laboratory must also demonstrate that they can interpret the results and reliably detect the drugs at the cut-off concentrations, which are in the table below for each of the two types of screening.

Finally, the laboratory must submit a test report with specific information to be kept in a secure location for a period consistent with the requesting authority’s policy or per the National Pathology Accreditation Advisory Council (NPAAC) Guidelines or equivalent.
AS/NZS 4760:2019 establishes a baseline for oral fluid drug testing in Australian/New Zealand workplace settings. It is designed for reliability, uniformity, and the creation of defendable results — not merely to establish compliant procedures.

This information serves as a guide only. Please seek your own independent advice when forming decisions.