The Mississippi State Department of Health is providing the following guidance for Mississippi laboratories that are certified by CLIA to perform high complexity testing to ensure availability of reliable testing for rapid detection of the agent that causes COVID-19.
The SARS-CoV-2 (virus that causes COVID-19) is a recently identified coronavirus that is associated with a human respiratory illness that can be severe. On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of SARS-CoV-2. Rapid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness.
Laboratories certified by CLIA to perform high-complexity testing can obtain validated EUA assay kits from an authorized manufacturer and verify test performance prior to implementing testing with the kit in their own laboratories. Assays that have been authorized for emergency use by the FDA remain subject to the CLIA regulations.
To perform testing and report patient test results, a laboratory must:
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 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. For more information, please refer to the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019.
FDA authorization: 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. More about the FDA EUA option »
State authorization: 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.
Currently, the State of Mississippi has decided to provide laboratories with an in-state process for COVID-19 testing authorization. Laboratories currently certified to perform CLIA high-complexity testing may develop their own SARS-CoV-2 test or modify a test currently authorized under an Emergency Use Authorization by following the steps below.
Please contact the MSDH at EUARequest@msdh.ms.gov with any COVID-19 EUA questions.
|FDA Policy for Diagnostic Tests for Coronavirus Disease-2019||https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency|
|More about the FDA EUA option »||https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations|
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