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 using Emergency Use Authorization (EUA) Assays
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:
- 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 prior to running patients for accuracy, precision, and other pertinent performance characteristics of the method. Any verification instructions provided by an EUA kit manufacturer must be followed. Validated EUA kits are not considered laboratory-developed tests (LDTs).
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.
Laboratory Developed Tests and the 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. 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.
How to Apply
- Obtain the MSDH SARS-CoV-2 Testing Evaluation Checklist for State of Mississippi EUA and complete all required assay performance evaluation steps identified in the document.
- Complete a MSDH SARS-CoV-2 Biosafety Risk Assessment for the test/assay as set-up in your facility.
- Complete the MSDH SARS-CoV-2 Nucleic Acid Amplification Testing Assay Validation Template for State of Mississippi EUA to demonstrate your laboratory’s completion of the required assay performance evaluation.
- When all validation studies are completed and your facility is ready to apply for testing authorization, submit the following to EUARequest@msdh.ms.gov:
- MSDH SARS-CoV-2 Testing Evaluation Checklist for State of Mississippi EUA
- MSDH SARS-CoV-2 Biosafety Risk Assessment
- After your email is received, your facility will be provided a link to an electronic storage file to upload the following:
- MSDH SARS-CoV-2 Nucleic Acid Amplification Testing Assay Validation Template for State of Mississippi EUA
- All validation data (instrument print-outs, data charts, etc.)
- Within 3 days of data receipt, your facility will be provided notification from the MSDH about your authorization status and any required data remediation.
- Authorization to perform the proposed test by the MSDH is required before patient testing may commence.
Please contact the MSDH at EUARequest@msdh.ms.gov with any COVID-19 EUA questions.