CLSI EP43
Implementing a Laboratory Test Under Emergency Use Conditions
This white paper delves into public health emergencies, exploring how emergency use authorizations (EUAs) can be utilized and the implications of EUAs for medical laboratories and other testing sites.
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Free
{{FormatPrice(nonMemberPrice)}} List PriceThis white paper is intended to help laboratories and manufacturers anticipate and prepare for using EUA tests under the challenging conditions described above. It provides general advice on points to consider and resources that may be available to help medical laboratories select and implement a suitable EUA test. Specifically excluded from this paper are general considerations of emergency preparedness (see CLSI document GP36).
EP43 follows the Test Life Phases Model introduced in CLSI document EP19, which describes how CLSI documents can be useful for a manufacturer that develops and validates a test, as well as the end-user laboratory that implements a test. For all tests, including those covered under an EUA, the performing laboratory is required to verify performance claims as part of implementation. This white paper focuses on ways laboratories can stay abreast of rapidly emerging information and how they can implement tests issued under an EUA.
EP43 does not focus on what manufacturers should consider in creating, developing, or validating a test intended for EUA. In the United States, the FDA provides information for test developers in EUA templates posted on the FDA's website. The regulatory requirements for manufacturers developing EUAs, and potentially for laboratories developing and using LDTs, vary depending on the jurisdiction and are therefore beyond the scope of this white paper. Test developers (both manufacturers and laboratories) should seek regulatory information directly from the pertinent regulatory authorities.
NOTE: This white paper is not intended to replace guidance from regulatory authorities for manufacturers or test developers for developing EUA tests. Changes in the EUA regulatory process may occur, and it is the test developer's responsibility to be aware of such changes.
This white paper is intended to help laboratories and manufacturers anticipate and prepare for using EUA tests under the challenging conditions described above. It provides general advice on points to consider and resources that may be available to help medical laboratories select and implement a suitable EUA test. Specifically excluded from this paper are general considerations of emergency preparedness (see CLSI document GP36).
EP43 follows the Test Life Phases Model introduced in CLSI document EP19, which describes how CLSI documents can be useful for a manufacturer that develops and validates a test, as well as the end-user laboratory that implements a test. For all tests, including those covered under an EUA, the performing laboratory is required to verify performance claims as part of implementation. This white paper focuses on ways laboratories can stay abreast of rapidly emerging information and how they can implement tests issued under an EUA.
EP43 does not focus on what manufacturers should consider in creating, developing, or validating a test intended for EUA. In the United States, the FDA provides information for test developers in EUA templates posted on the FDA's website. The regulatory requirements for manufacturers developing EUAs, and potentially for laboratories developing and using LDTs, vary depending on the jurisdiction and are therefore beyond the scope of this white paper. Test developers (both manufacturers and laboratories) should seek regulatory information directly from the pertinent regulatory authorities.
NOTE: This white paper is not intended to replace guidance from regulatory authorities for manufacturers or test developers for developing EUA tests. Changes in the EUA regulatory process may occur, and it is the test developer's responsibility to be aware of such changes.