LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests
On June 4, 2020, the Department of Health and Human Services (HHS) announced new laboratory data reporting guidancepdf iconexternal icon for COVID-19 testing. Using LOINC and SNOMED-CT to identify and report SARS-CoV-2 test results in electronic reporting systems will facilitate timely and quality data reporting to state and federal public health agencies. The following document (developed per the LIVD specificationexternal icon) provides LOINC and SNOMED mappings for SARS-CoV-2 diagnostic tests available in the United States. The LIVD mapping catalogue provides coding for these data elements: LOINC test order, LOINC test result, SNOMED-CT test description, SNOMED-CT specimen source, and Device Identifier.
Mapping tool: LIVD SARS-CoV-2 Test Codes.xlsxexcel icon
LIVD publication date 2020-11-18.
CDC and its partners will review and update this tool as needed for new or discontinued tests. For more information or to contact CDC about this tool, email DLSInquiries@cdc.gov and use “LIVD Test Code Mapping Tool” in the subject line.
CDC publishes this information in collaboration with partners as a service to users. Partners include:
- The United States Food and Drug Administration (FDA)
- IVD Industry Connectivity Consortium (IICC)
- The Regenstrief Institute
- SNOMED International
- Association of Public Health Laboratories (APHL)
Users include (but are not limited to):
- Clinical laboratory personnel
- Federal, state, and local public health agencies
- IVD test developers or manufacturers
- Laboratory Information System (LIS) and Electronic Health Records (EHR) vendors
Partners and users should know that publication on this website does not infer an endorsement by CDC of any of the instruments or companies listed in this document. The use of an asterisk (*) next to a code in this tool means that the code has not been verified by the manufacturer; therefore, CDC cannot attest to the accuracy of the code. Test developers or manufacturers of one of these tests can contact FDA at SHIELD-LabCodes@fda.hhs.gov for information about verifying codes with CDC and its partners in this project, and should use this email address to provide feedback to FDA about the mapping tool.
If you need assistance to read the Excel spreadsheet presented here, please email DLSInquiries@cdc.gov and use “LIVD Test Code Mapping Tool” in the subject line.
Use of codes defined in the LIVD mapping tool will harmonize code selection between health care systems. Harmonization of codes between healthcare systems has been shown to improve semantic interoperability for laboratory reporting. The FDA, CDC, IICC, Regenstrief Institute, and APHL have developed this mapping tool for all SARS-CoV-2 diagnostic tests listed on the FDA Emergency Use Authorizationsexternal icon website. The LIVD mapping tool provides a concise document that defines LOINC and SNOMED-CT codes for reporting to public health agencies. The use of this mapping tool should reduce inaccuracies and time spent on the import of laboratory test results sent through laboratory information systems.
The LIVD specification outlines an industry-defined format to facilitate the publication and exchange of LOINC codes for vendor IVD test results, based on either vendor IVD test transmission codes or manual test identification, for use by laboratory personnel or laboratory applications. The format can be used as-is by IVD software systems to automate the mapping between vendor IVD test transmission codes and LOINC codes, significantly reducing the risk of erroneously mapped test results and units of measure. Find more information about the LIVD specification at http://ivdconnectivity.org/livdexternal icon.
Public health surveillance for reportable and nationally notifiable diseases and conditions relies on laboratory criteria to support case definitions and classification. The mapping of test results for electronic laboratory reporting systems used by clinical laboratories is challenging due to the numerous test platforms available. The ability for computer systems to transmit data that is unambiguous and has shared meaning (semantic interoperability) is needed to harmonize the large volume of laboratory test data both within and especially between healthcare systems.
A multi-stakeholder public-private partnership, Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) was convened to harmonize laboratory coding by ensuring the same type of test is described the same way using terminology standards, e.g., Logical Observation Identifiers Names and Codes (LOINC®), Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT®), Unique Device Identifiers (UDI), and Unified Code for Units of Measure (UCUM).
In June 2018, the Food and Drug Administration published guidance titled “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Testsexternal icon” to encourage instrument manufacturers to provide LOINC codes for their tests. IVD manufacturers are providing LOINC using the digital format provided by the IVD Industry Connectivity Consortiumexternal icon (IICC).
To increase semantic interoperability for laboratory reporting for detection of SARS-CoV-2, the FDA, CDC, IICC, Regenstrief Institute, and APHL have developed a LOINC map for all SARS-CoV-2 diagnostic tests listed on FDA Emergency Use Authorizationsexternal icon. The use of this mapping tool could reduce inaccuracies and time spent on the import of laboratory test results sent through laboratory information systems.
Find more information about this topic from:
- CDC COVID-19 Data and Reporting Q&A
- SARS-C0V-2 LOINC codes and Basicsexternal icon
- SNOMED CT Basicsexternal icon
- FDA FAQs on Diagnostic Testing for SARS-CoV-2external icon
- FDA Emergency Use Authorizationsexternal icon
- NIH Value Set Authority for COVID-19external icon
- Interoperability Standards Advisory for COVID-19 Novel Coronavirus Pandemicexternal icon