Veterinary point of care tests (PoCT) provide field-based or “pen-side” diagnostic information about disease states in animals. Implementation of PoCT tests will support more equitable and efficient access to veterinary testing across NSW, improving animal health outcomes and enhancing surveillance and emergency disease response activities. However, misuse or misinterpretation of tests and inaccurate test results for prohibited matter diseases represents a significant biosecurity risk with implications for producers, vets, communities, and industries. Due to these risks, PoC testing for prohibited matter is prohibited in NSW. It is an offence under Section 28 of the Biosecurity Act to deal with prohibited matter, and clause 4 of the Biosecurity Regulation 2017 states that testing for the presence of biosecurity matter is a dealing. Use of a PoCT for prohibited matter can only be conducted under an exemption order or prohibited matter permit.
Accreditation of a PoCT by the Australian Sub-committee of Animal Health Laboratory Standards (SCAHLS) or the World Animal Health Organisation (OIE) indicates fitness of a novel PoCT, which has been properly developed, optimised and standardised, for an intended purpose. In the absence of such accreditation, novel PoCT for prohibited matter need to be appropriately validated against their intended purpose and used by competent individuals according to manufacturer and regulatory standards to minimise the risk of a biosecurity event occurring. This policy describes the quality objectives and requirements for validation, implementation, management and use of PoCT for the purposes of diagnosis or screening for prohibited matter in NSW. It seeks to harmonise regulation of veterinary PoCT in NSW with other jurisdictions and regulatory approaches for human PoCT and promote a shared responsibility for mitigating biosecurity risk.