Draft Details

1.1     General

This Standard applies to targeted qPCR eDNA assays used to conduct eDNA biological surveys or assessments.

This Standard provides performance criteria pertaining to:

a)reporting

b)analytical performance, including the following criteria:

    i)specificity,

    ii)sensitivity,

    iii)quantification,

    iv)repeatability, and

     v)reproducibility.

c)field application, including:

     i)verification of target taxon detection using a sample matrix,

     ii)technical replicates run per environmental sample

     iii)assay controls for false positive (Type 1) errors, and

      iv)assay controls for false negative (Type 2) errors.

This Standard does not address field components, including sampling strategy and methodology, or interpretation of field survey results that accompany data generated from targeted eDNA assays. These elements are beyond the scope of the current Standard. It is important to acknowledge that standards suggested in this document may be influenced by upcoming standards for previous steps (e.g., sampling design, sampling methods) of an eDNA assay.

1.2     Users

This Standard is intended for use by the following primary users:

a)testing entities developing and using eDNA assays including commercial, industrial, government, and academic laboratories.

The Standard will also be used by and benefit:

b)industrial and commercial proponents of resource development projects whose businesses can have direct or indirect influences on aquatic and other ecosystems;

c)regulatory agencies including, but not limited to federal, Indigenous, provincial, and municipal resource managers;

d)contract administrators who oversee projects that utilize any aspect of eDNA methodology;

e)non-government stakeholders, including environmental non-government organizations, that may undertake eDNA monitoring studies or review or audit eDNA projects for compliance with reasonable expectations for due diligence;

f)professional biologists and qualified environmental professionals who undertake eDNA monitoring studies or who might audit a project to ensure competency and completeness;

g)academic researchers and educators for the purposes of improving and advancing the collective field of genetics research; and

h)others with a vested interest in eDNA studies, including aspects of project design, execution, and results interpretation.

1.3     Application

The requirements provided in this Standard apply to practitioners engaged in the delivery of targeted qPCR-based eDNA studies and the reporting of their results. Project results could influence decisions affecting the conservation and management of natural resources. Application of the Standard outlined herein will enable effective evaluation of methods during project implementation and enhance confidence in decision-making based on the project results.

1.4     Intended use

This Standard applies to the performance criteria of targeted qPCR assays used in eDNA studies and surveys. This Standard shall be used in conjunction with the CSA Group standard CSA/W214-21, Environmental DNA Reporting Requirements and Terminology, and should be used in conjunction with other Standards, e.g., ISO/IEC 17025, to enable laboratories to demonstrate that they operate competently and generate valid results.

While this Standard focuses on the most widely used eDNA detection methods, it is recognized that other methods may be suitable. This Standard is not intended to constrain future developments in eDNA approaches, methodologies, or implementations.

The elements of this Standard are relevant to multiple steps in the eDNA workflow addressed in the CSA Group standard CSA/W214-21, Environmental DNA Reporting Requirements and Terminology. Users shall read and refer to this Standard and the CSA Group standard CSA/W214-21 in their entirety.

Where quantitative measurements are required, users shall report these measurements using relevant standard measures and units.

1.5     Terminology

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy to comply with the Standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate explanatory or informative material from the text.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.