ANZSDP Policy - Establishing the Need
Policy : Establishing the Need for an Australian and New Zealand Standard Diagnostic Procedure (ANZSDP)
1. Background
The Subcommittee on Animal Health Laboratory Standards (SCAHLS) seeks to sustain and improve the quality of livestock and livestock products and to assure market access through the application of best practice to veterinary laboratory services. Publication of standard laboratory procedures is an integral component of best practice.
The primary objectives of ANZSDPs are to facilitate the performance of test procedures and to ensure consistency between laboratories by using methods selected for their optimal accuracy, sensitivity, specificity and robustness. Secondary objectives are to provide guidelines for the methods to be used in external proficiency testing programmes and to aid the development of documentation for quality systems.
Procedures are made available in a retrievable electronic format from the SCAHLS website (http://www.scahls.org.au/). These describe tests and the availability of reagents consonant with the OIE Manual of Standards For Diagnostic Tests and Vaccines (http://www.oie.int/eng/normes/mmanual/A_summry.htm). The procedures are amenable to revision as required.
Any tests that differ in principle from an established (standard) test must be successfully evaluated by SCAHLS 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 to SCAHLS for evaluation. Tests will be evaluated in accordance with procedures for new test development and evaluation (Refer to SCAHLS New Test Development and Evaluation SOP and Policy documents).
2. Purpose
This policy describes the requirements and process for establishing the need for an ANZSDP and provides a brief outline of the editorial, approval and publication process. The policy is designed to help laboratory scientists, and others, to understand the rationale used in the selection and development of ANZSDPs.
3. Scope
This Policy applies to procedures developed for use in Australia and New Zealand veterinary laboratories.
4. Policy
The need for a new ANZSDP, or revision of an existing ANZSDP or Australian Standard Diagnostic Technique (ASDT) is determined by SCAHLS, often in consultation with senior Australian and New Zealand scientists. A senior author, and co-authors if necessary, are nominated by SCAHLS members in session.
The senior author, co-authors, SCAHLS Editor and SCAHLS Editorial committee work together to produce the final document. Following SCAHLS and Animal Health Committee (AHC) approval, the ANZSDP is published on the SCAHLS website (see SCAHLS Editorial and Approval Process for ANZSDPs)
To decide if a new procedure is warranted, consideration is given to a number of eligibility criteria.
An ANZSDP is warranted when at least one of the following eligibility criteria is satisfied:
- Laboratory testing is required for regulatory or industry-driven disease control programmes.
- Laboratory testing is required for the export of animals or animal products.
- Laboratory testing is required for major endemic diseases (those affecting a significant proportion of national herds and flocks).
- The disease occurs in Australia, has considerable industry significance, and the OIE standard is inadequate.
- Laboratory testing is required to confirm the presence of a significant zoonotic disease in animals.
5. Application
SCAHLS 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, in session, to satisfy one or more of the eligibility criteria. All procedures are reviewed six-monthly by SCAHLS.
New and revised ANZSDPs are designed to harmonise with the latest OIE version (where they exist) and are edited for consistency of information and style. When an ANZSDP is developed and an OIE version exists, the background information will reflect the OIE version, but may be revised to describe the disease in an Australian context.
Existing OIE procedures are generally suitable for Australian and New Zealand laboratories for those diseases to which none of the eligibility criteria (above) apply. However, SCAHLS may seek an expert scientific assessment of an existing OIE Procedure to determine if an ANZSDP is warranted.
In the event that an expert needs analysis is required, a relevant expert is nominated by SCAHLS members, in session. The SCAHLS Executive Officer (EO) writes to the nominated expert (Attachment 1) requesting a needs analysis and recommendations.
When a recommendation to develop an ANZSDPs is approved, the EO prepares an agenda paper for consideration at the next meeting of the committee. Nominations for authorship are then considered in session.
When nominations are received, development proceeds as described in ‘SCAHLS Editorial and Approval Process for ANZSDPs’.
Final approval for ANZSDPs is granted by Animal Health Committee (AHC) and publication is by posting on the SCAHLS website.
6. Exclusions
An ANZSDP will normally exclude those tests that have not been validated and approved by SCAHLS. However, the inclusion of procedures for the diagnosis of newly described, emerging or exotic diseases may be approved by the committee in some circumstances.
7. Accompanying Documentation
All accompanying documentation supporting this Policy can be found on the SCAHLS website (www.scahls.org.au) :
- SCAHLS Standard Operating Procedure: Writing an ANZSDP.
- SCAHLS Editorial and Approval Process for ANZSDPs.
- SCAHLS New Test Development and Evaluation Policy.
- SCAHLS Process for Managing New Test Approvals.
- SCAHLS Validation Templates for Serological and Nucleic Acid Detection Tests.