SARS-CoV-2 (formerly 2019-nCoV) is a recently identified coronavirus that causes human respiratory illness that can be severe. COVID-19 is the term used for illness caused by the virus. For purposes of this document, COVID- 19 and SARS-CoV-2 are synonymous.
The CAP is providing the following guidance for CAP-accredited laboratories to ensure availability of reliable testing for rapid detection of the agent that causes COVID-19.
Laboratories using Emergency Use Authorization (EUA) Assays
CAP-accredited laboratories can obtain validated EUA kits from an authorized manufacturer and verify test performance to perform testing in their own laboratories. To perform testing and report patient test results, a laboratory must:
- Meet all personnel requirements for performance of moderate- and high-complexity testing.
- Follow the assay or test system's protocol as authorized by the US Food and Drug Administration (FDA) without modification.
- Verify test method performance specifications on site following the CAP’s All Common Checklist requirements COM.40300, COM.40475, and COM.40500. Validated EUA kits are not considered laboratory-developed tests (LDTs).
- Include both positive and negative samples in the study.
- Update the laboratory’s CAP activity menu using the following, newly added activities:
- nCoV 2019, amplif. (includes rapid)(EUA/not FDA) OR
- nCoV 2019 antibodies.
- RNA/DNA Extraction – the CAP is temporarily allowing laboratories to accept extractions from non-accredited sites following validated extraction procedures.
Laboratories must perform quality control each of day of patient testing. For checks of new reagent lots and shipments, the laboratory may use reference materials or controls provided by the manufacturer. The CAP encourages laboratories to continue to evaluate assay performance as testing continues and more positive specimens become available for verification studies.
LDTs and Development of EUA Assays
The FDA issued a revised guidance on March 16, 2020, which offers two different options for accelerating the development of certain laboratory tests for COVID-19.
- The first option involves pursuing EUA from the FDA as described in the FDA guidance released on February 29, 2020 and in the revised guidance. This option allows testing to be performed after completion of the validation, but before the laboratory receives EUA from the FDA. The FDA recommends submitting an EUA request within 15 days after completing the validation.
- The second option allows state authorization of high-complexity, CLIA-certified laboratories to perform tests developed and validated by their laboratory for COVID-19 in their state. If a state chooses to authorize laboratories within its state to develop and perform a test for COVID-19, it does so under the authority of its own State law, and under a process that it establishes. Laboratories developing tests following this path engage directly with the appropriate state authorities, instead of with the FDA. These laboratories are not required to pursue an EUA with the FDA.
The revised guidance also includes new information for commercial manufacturers to expand the nation’s capacity for COVID-19 testing during the public health emergency. The FDA guidance states that it does not intend to object to commercial manufacturers developing and distributing COVID-19 test kits after completion of the manufacturer’s validation of the test for specimen testing prior to the FDA granting an EUA, under certain conditions. The FDA considers 15 days a reasonable period of time to prepare and submit an EUA request.
The revised guidance also includes new information for commercial manufacturers and laboratories developing and using serology tests that identify antibodies (eg, IgM, IgG) to COVID-19 from clinical specimens. These tests are considered less complex than molecular tests and provide more limited information.
Laboratories performing an LDT should refer to the following CAP checklist requirements for validation of LDTs in the All Common Checklist: COM.40350, COM.40500, COM.40850. Additional requirements in the All Common Checklist and Microbiology Checklist apply.