COVID-19 Related Test Data and Reporting: FAQs on Testing for SARS-CoV-2
This page is part of the FAQs on Testing for SARS-CoV-2 and provides answers to frequently asked questions related to COVID-19 related test data and reporting.
Questions and answers regarding other policies described in the Policy for Coronavirus Disease-2019 Tests are found in other pages in this section.
Q: I am a laboratory performing COVID-19 testing. Do I need to report COVID-19 test results to public health authorities? (05/12/23)
A: Laboratories are required to report to state and local public health authorities in accordance with applicable state or local law.
For additional information, see the Diagnostic Data & Reporting page 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.
Q: When reporting COVID-19 related test results to appropriate public health authorities, should I use standard terminology (i.e., LOINC and SNOMED-CT)? (11/15/21)
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:
- CDC Frequently Asked Questions on Laboratory Data Reporting Guidance for COVID-19 Testing
- SARS-CoV-2 LOINC codes and Basics
- SNOMED CT Basics
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:
- Test developers: SHIELD-LabCodes@fda.hhs.gov.
- Test users (e.g., laboratories/healthcare providers): email@example.com.
Q: I have developed a SARS-CoV-2 test kit for distribution to clinical laboratories that are required to report test results to appropriate public health authorities. How can I assist laboratories to meet their reporting obligations? (5/27/20)
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.