Before any work can commence, we must first establish the need for:
- a new Australian and New Zealand standard diagnostic procedure (ANZSDP), or
- revision of an existing ANZSDP or Australian standard diagnostic technique (ASDT).
This is part of a process to draft and review ANZSDPs by scientific experts, managed through a set of standardised procedures.
Policy
1. Background
The primary objective of an Australian and New Zealand standard diagnostic procedure (ANZSDP) is to standardise test procedures so as to ensure consistency between laboratories using methods selected for their optimal accuracy, sensitivity, specificity and robustness. Other objectives include the provision of standard methods that can be used in external proficiency testing programs and for the development of documentation for quality systems.
ANZSDPs describe tests and the availability of reagents consistent with the World Organisation for Animal Health (OIE) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals or the Manual of Diagnostic Tests for Aquatic Animals (hereafter referred to as ‘OIE Manual’). ANZSDPs are amenable to revision as required. Any tests that differ in principle from an established (standard) test must be favourably evaluated by the National Laboratory Task Group under the Animal Health Committee (AHC), before inclusion in an ANZSDP. Commercial suppliers and individual proponents seeking inclusion of a new test, or a new version of an existing test, in an existing ANZSDP will need to submit relevant data and information to AHC for evaluation. Tests will be evaluated in accordance with procedures for new test development and evaluation.
2. Purpose
This document describes the criteria and process for establishing the need for an ANZSDP, including a brief outline of the editorial, approval and publication process. The policy is designed to help laboratory diagnosticians and other scientists to understand the rationale used in the development of ANZSDPs.
3. Scope
This policy applies to terrestrial and aquatic ANZSDPs and any associated procedural documents managed by the National Laboratory Task Group.
4. Policy and process
The need for a new ANZSDP, or revision of an existing ANZSDP or Australian standard diagnostic technique (ASDT), is determined by the National Laboratory Task Group, often in consultation with relevant senior Australian and New Zealand scientists. Where relevant and if available, previous authors should be included in the revision of existing ANZSDPs. Laboratory task group members nominate a senior author and, if necessary, one or more co-authors (alternatively the senior author may nominate a co-author/s). If the nomination is accepted, the author/s and the National Laboratory Task Group work together to produce the final document. Following AHC approval, the final version of the ANZSDP is published on the Department of Agriculture, Fisheries and Forestry website—see Australian and New Zealand standard diagnostic procedures (ANZSDPs).
How to decide whether or not an ANZSDP is warranted
Did the Animal Health Committee (AHC) determine the need for a national standard operating procedure for a particular disease?
No, an ANZSDP is not required for this disease.
Yes, find out if there a relevant chapter in the OIE Manual for this disease.
Is there a relevant chapter in the OIE Manual for this disease?
No, find out if laboratory testing is required for regulatory purposes or industry-driven disease management.
Yes, determine whether the relevant OIE Manual chapter is adequate for Australian needs.
Is the relevant OIE Manual chapter adequate for Australian needs?
No, find out whether laboratory testing is required for regulatory purposes or industry-driven disease management.
Yes, an ANZSDP is not required for this disease.
Is laboratory testing required for regulatory purposes or industry-driven disease management?
No, an ANZSDP is not required for this disease.
Yes, an ANZSDP is required for this disease.
Did the Animal Health Committee (AHC) determine the need for a national standard operating procedure for a particular disease?
No, an ANZSDP is not required for this disease.
Yes, find out if there a relevant chapter in the OIE Manual for this disease.
Is there a relevant chapter in the OIE Manual for this disease?
No, find out if laboratory testing is required for regulatory purposes or industry-driven disease management.
Yes, determine whether the relevant OIE Manual chapter is adequate for Australian needs.
Is the relevant OIE Manual chapter adequate for Australian needs?
No, find out whether laboratory testing is required for regulatory purposes or industry-driven disease management.
Yes, an ANZSDP is not required for this disease.
Is laboratory testing required for regulatory purposes or industry-driven disease management?
No, an ANZSDP is not required for this disease.
Yes, an ANZSDP is required for this disease.
5. Application
The National Laboratory Task Group determines the need for revision of an existing ANZSDP, a new ANZSDP to replace an existing ASDT, or a new ANZSDP, based on evidence presented to satisfy the eligibility criteria.
New and revised ANZSDPs are designed to harmonise with the latest OIE Manuals (where they exist) and are edited for consistency of information and style. When an ANZSDP is developed and a relevant OIE Manual exists, the background information will reflect the OIE Manual, but should reflect the Australian and New Zealand context.
Existing OIE Manuals are generally suitable for Australian and New Zealand laboratories for those diseases to which none of these eligibility criteria apply. However, the National Laboratory Task Group may seek an expert scientific assessment of an existing OIE Manual to determine if an ANZSDP is warranted. Alternatively the relevant OIE Manual may be circulated to National Laboratory Task Group members, to determine whether it meets Australian and New Zealand needs.
In the event that an expert needs analysis is required, a relevant expert is nominated by National Laboratory Task Group members. The National Laboratory Task Group Executive Officer (EO) then writes to the nominated expert requesting a needs analysis and recommendations. This expert service is not expected to incur any fees.
When a recommendation to develop an ANZSDP is proposed, the EO prepares an agenda or out-of-session paper, which is circulated to National Laboratory Task Group members for approval of the ANZSDP and nominations for authorship. If National Laboratory Task Group members approve the need for a new or revised ANZSDP, endorsement is sought from the AHC for both the particular ANZSDP and the nominated author/s. If nominations are endorsed by the AHC, development proceeds as described in the editorial and approval process for ANZSDPs.
Final approval of an ANZSDP is granted by the AHC and publication is by posting on the Department of Agriculture, Fisheries and Forestry website.
6. Exclusions
An ANZSDP will normally exclude tests that have not been approved by the National Laboratory Task Group. However, the inclusion of tests that have not been approved may be appropriate, subject to National Laboratory Task Group approval.