CDC LOCS Lab Advisory: Guidance for LOINC In-Vitro Diagnostic (LIVD) Code Selection for Laboratories Using Laboratory-Developed Tests

For laboratories and testing sites that are using a Laboratory-Developed Test (LDT) that has not received a U.S. Food and Drug Administration Emergency Use Authorization (EUA), refer to these tips and links when selecting codes to report test results to public health agencies:

• LOINC and SNOMED-CT codes should identify the test that is being performed, not the in-vitro diagnostic (IVD) device used to process the test.
  • Regenstrief/LOINC provides information to select codes for Test Order and Test Result, SARS-CoV-2 LOINC Codes, and Basics. If you are familiar with LOINC coding, use the search function.
  • SNOMED-CT provides a list of codes to identify Laboratory Test Results Qualifier Values and Specimen Source.
• The Device Identification (DI) should include values for both the test kit and the IVD device.
  • The test kit is identified by “test kit name_manufacturer.” If the test kit has received an EUA, you may use the test kit name provided in the instructions for use . The manufacturer is the name of the laboratory that developed the test.
  • The IVD DI may be obtained from the manufacturer or found using ACCESSGUDID.

Laboratories may seek authorization for LDTs, but are not required to do so. If the LDT receives an EUA, the EUA will be added to the LOINC In-Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests.

Online resources:

• SNOMED-CT Basics
• FDA FAQs on Diagnostic Testing for SARS-CoV-2
• FDA Emergency Use Authorizations
• NIH Value Set Authority for COVID-19
• Interoperability Standards Advisory for COVID-19 Pandemic
• Interim Guidance for Rapid Antigen Testing for SARS-Cov-2
• COVID-19 Information for Laboratories
• Frequently Asked Questions about COVID-19 for Laboratories
• How to Report COVID-19 Laboratory Data
• CDC COVID-19 website
• Clinical Laboratory COVID-19 Response Calls
• CDC Laboratory Outreach Communication System (LOCS)

If you have any questions, please contact LOCS@cdc.gov.

This Lab Advisory was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.