This page provides answers to frequently asked questions related to COVID-19 related test data and reporting.
This section includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised). In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.
For a directory of FAQs related to SARS-CoV-2 testing, see FAQs on Testing for SARS-CoV-2.
A: Laboratories are required to report to state and local public health authorities in accordance with applicable state or local law.
In addition, under section 18115 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Public Law 116-136), laboratories, including those in patient care settings operating under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation, must report the results of COVID-19 tests to the Department of Health and Human Services (HHS) or its designee, in such form and manner as the Secretary may prescribe, during the declared public health emergency.
For additional information, see the laboratory data reporting guidance and FAQs from the Department of Health and Human Services (HHS).
When FDA issues an Emergency Use Authorization (EUA) for a COVID-19 test, the letter of authorization includes a condition that requires authorized laboratories performing COVID-19 testing to have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. FDA considers this condition to include authorized laboratories reporting test results to HHS in accordance with section 18115 of the CARES Act.
A: In order to reduce reporting burdens for testing facilities and ensure that the core COVID-19 related test data is accurate and meaningful, pre-harmonized terminology standards -- LOINC and SNOMED-CT codes -- are available. Using this basic and simple approach to ensuring the same test is described the same way can help establish infrastructure needed to accomplish our mission of protecting and promoting public health.
Testing facilities' use of LOINC and SNOMED-CT terminology standards, when available, should help improve the accuracy of reporting of their SARS-CoV-2 and COVID-19 related test results. As noted on the CDC's Reporting COVID-19 Laboratory Data page, standard use of these laboratory terminology codes ensures that the same type of test is represented uniformly across the United States.
For IVD tests, LOINC codes can be used to represent the "question" a diagnostic test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes can be used to represent the diagnostic "answer" (e.g., SARS-CoV-2 RNA was detected). For more information on laboratory data reporting, and these terminology standards please refer to:
For assistance in the assignment of LOINC and SNOMED codes, please refer to the LIVD mapping catalog for available SARS-CoV-2 tests and/or contact:
A: Assistance from test developers can be invaluable in harmonizing the application of terminology standards (i.e., LOINC, SNOMED-CT and UCUM) and helping ensure that the same type of test is described the same way. This helps to enable Real-World Evidence (RWE) aggregation and analysis. For all SARS-CoV-2 tests, developers can supply pre-harmonized LOINC codes representing the "question" a diagnostic test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes representing the diagnostic "answer" (e.g., SARS-CoV-2 RNA was detected).
For support in the assignment of appropriate LOINC and SNOMED-CT codes or to request modification of your test in the LIVD mapping catalog for SARS-CoV-2 tests, SARS-CoV-2 test developers can contact SHIELD-LabCodes@fda.hhs.gov.