scope:

General

This Standard specifies the minimum requirements and best practices for the development, validation, and use of laboratory-developed tests in clinical and research laboratories for the screening, diagnosis, and management of clinical conditions.

It does not provide specific details on how to achieve these requirements since they are provided in many other sources which are considered current best practice. References to these resources will be provided in this Standard.

Note: See also Annex Afor recommended resources.

Inclusions

The Standard is intended to be used by organizations and individuals that are developing LDTs for the purpose of providing results that can be used in the screening, diagnosis, or management of clinical conditions.

Exclusions

This Standard does not apply to the following:

a) tests developed in-house but distributed outside of the laboratory;

Note: Tests distributed outside of the laboratory fall outside the definition of "laboratory-developed test". These are considered to be commercially distributed IVDDs and are regulated by Health Canada under the Medical Devices Regulations.

b) LDTs that are developed by a laboratory or manufacturer solely for RUO or IUO (i.e., where there is no reporting of patient results); and

c) accredited, non-clinical laboratories which have their own standard for development, validation, and use of LDTs.

The Standard does not apply to laboratory-developed tests that are developed by a laboratory for RUO/IUO until such time that the test becomes applied to clinical testing and has undergone suitable validation according to the requirements in this Standard.

Notes:

1) The RUO/IUO labeling is meant to serve as a warning to prevent such products from being used in clinical diagnosis or patient management. However, clinical laboratories can validate tests using RUO reagents or components through their own procedures as described in this Standard, and subsequently offer it for clinical diagnostic use as a laboratory-developed test once validated.

2) Refer also to the Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only. Guidance for Industry and Food and Drug Administration Staff document issued on November 25, 2013, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety.

Terminology

In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order 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 from the text explanatory or informative material.

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

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.