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Procedure

New Test Development and Evaluation Procedure

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. Guidelines have been developed to assist laboratory scientists in the development and approval of new diagnostic tests through to their inclusion in Australian and New Zealand Standard Diagnostic Procedures (ANZSDPs) (http://www.scahls.org.au/). The first step encompasses the development of the test to the point where it is eligible for submission to SCAHLS for evaluation. If approved, the test may be included in the relevant ANZSDP at its next revision.

2. Purpose

The purpose of this procedure is to detail the process and responsibilities for managing new test development and evaluation.

3. Scope

This procedure applies to the development, evaluation and approval of new laboratory tests for diseases of production, feral, captive and leisure animals.

4. Definitions and references

Diseases – include infectious, toxic, parasitic, neoplastic, developmental, genetic, congenital, immunologic and nutritional diseases.

Production animals – include cattle, sheep, pigs, goats, alpaca, llama, buffalo, camel, deer, rabbits, poultry, crocodiles ,emus, ostrich and rhea.

Wild animals – include captive and wild native animal and introduced species including terrestrial and avian species.

Leisure animals – include horses, dogs, cats, caged birds and fancy breed poultry

5. Procedure

5.1 New Test Development

5.1.1 Working Group Members

New Test Development (NTD) will be facilitated by a working group led by an independent chair. The working group will consist of 3 or 4 members with relevant expertise in serological tests and/or Nucleic Acid Detection (NAD) and/or validation. Members will preferably have some corporate knowledge on the SCAHLS New Test Development and Evaluation Policy (http://www.scahls.org.au/).

5.1.2 New Test Development Records

5.1.2.1

The Chair will consult with SCAHLS members twice yearly for the purpose of updating records. Each State representative will receive a list of tests under development and will be required to provide an update to the Chair prior to each SCAHLS meeting.

5.1.2.2

The Chair will maintain and update a spreadsheet with lists of the following:

  • New tests being developed
  • Tests in routine use in diagnostic laboratories (often validated in-house, to OIE Stage II, but not submitted to SCAHLS for inclusion in ANZSDPs).
5.1.2.3

The working group will develop and maintain validation templates for submissions of new tests for evaluation and the Chair will provide an update of these at SCAHLS meetings.

5.2 New Test Evaluation

5.2.1 Working Group Members

New Test Evaluations (NTE) will be facilitated by a working group led by a member of SCAHLS. The working group will consist of members with relevantexpertise in serological tests and/or (NAD) and /or validation. Members will preferably have some corporate knowledge on the SCAHLS NTD and NTE Policy. All assessors are requested to ensure confidentiality and should declare any conflicts of interest to the Chair when it arises.

5.2.2 New Test Approval Process

(whether via SCAHLS working group or a contracted provider).

5.2.2.1

Submitters will forward dossiers to the SCAHLS E/O in electronic (PDF) format.

5.2.2.2

The Chair of the NTE Group will review submitted information to determine if it is in the correct format and provides sufficient validation data to be assessed. If not, it will be returned to the submitter with feedback explaining the corrective action required.

5.2.2.3

The working group will assemble a review panel. This should consist of two or more independent technical assessors who are experts in a relevant field and/or assay validation and may include members of the NTE working group.

5.2.2.4

Written reports from the assessors will be received by the NTE Chair and considered by the NTE working group. Where reviewers have differing opinions the working group will make the final decision to recommend, or not, the new test to SCAHLS for inclusion in ANZSDP.

5.2.2.5

The NTE Chair will complete the NTE Recommendation Template for consideration by SCAHLS members. The document will be forwarded to members OOS with a deadline of 4 weeks for approval; 2 weeks to provide any comments back to the working group and to resolve issues; 2 weeks to confirm acceptance or non-acceptance.

5.2.2.6

Endorsement of the new test will be by SCAHLS consensus (no dissenting voices). Approvals can also be granted subject to conditions.

5.2.2.7

Written feedback (consensus opinion) will be provided to the submitter from the Chair NTE. This will confirm the submission has been approved or provide a summation of the assessment and recommendations for remedial action. The assessors will not be identified in this communication.

5.2.2.8

Submitters may choose to resubmit the test after inclusion of further information. Where this is done within 6 months, the same review panel should be used to ensure faster turnaround times.

5.2.3 New Test Evaluation Records
5.2.3.1

The Chair of the NTE Group will maintain a summary list of tests under consideration, approved tests and relevant dates, correspondence and decisions. This information should be communicated to the SCAHLS E/O 6 monthly or at the next meeting of SCAHLS.

5.2.3.2

The Chair will provide an update of NTE activity at SCAHLS Meetings.

5.2.4 Target timeline for the assessment process
  • Review by NTE group and decision to proceed 2 weeks
  • Finding and confirming reviewers for protocol 3 weeks • Review by the assessment panel 3 months
  • Collation of assessors reports and development of recommendations to SCAHLS 4 weeks
  • SCAHLS review and recommendations. Provide written feedback to submitter 2 weeks
5.2.5 Costs

Charges are due at the time of submission to SCAHLS and will be invoiced once the submission is sent for independent review by an assessment panel. Payment for submissions will be used to cover costs of the reviewers. The SCAHLS E/O is responsible for invoicing the submitter to recoup these costs. The costs may be reviewed by SCAHLS from time to time and initially will be $3000 for new submissions. Extensions might be considered where the minor changes would not impact significantly on the fitness for purpose of the assay involved. The cost for review of an extension to an existing assay will be $2000. Assays submitted as extensions, that are not accepted by SCAHLS as extensions, may be resubmitted as a new test with payment of an additional $1000. SCAHLS decision on the evaluation of submitted dossiers will be final. Submitters may review and resubmit within six months, and will incur a cost of A$500.

6. Documentation

The following documentation supporting this procedure can be found on the SCAHLS website (www.scahls.org.au) or are available from the SCAHLS EO.

  • SCAHLS validation templates for serological and nucleic acid detection tests.
  • SCAHLS validation template for extension of existing assays.
  • SCAHLS ANZSDP Guide for Authors Policy and SOP.
  • SCAHLS New Test Development and Evaluation Policy (This Policy replaces the ‘Guidelines for New Diagnostic Tests’ Version 1).
  • SCAHLS New Test Evaluation Recommendation Template