Skip to Main Navigation Skip to Main Content Skip to Footer
search play2 play3 facebook twitter linkedin2 cross
ASCP
  • DASHBOARD
  • STORE
  • LOGOUT
  • STORE
  • LOGIN
Menu
  • My Role
  • Membership
  • Learning
  • Get Involved
  • Careers
  • About ASCP
  • Board of Certification
  • News
  • News
  • News Archive
  • Groups
  • Jobs
  • ASCP
  • News Archive
  • News Detail

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

Publication Date: Oct 5, 2020

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.

  • My Role
    • Pathologist
    • Resident
    • Lab Professional
    • Program Directors
    • Student
  • Membership
    • Renew Membership
    • Become a Member
    • Get Involved
    • Rewards
    • Member Center
  • Learning
    • Certificate Programs
    • Attend Live Events
    • Explore Books and Journals
    • Quality Improvement Education
    • Access My Education
    • ACCME
    • CC Resources
    • CMP Resources
    • ASCPedia
    • Featured Education
    • Immuno-Oncology
    • ASCP Annual Meeting
    • ASCP Virtual Town Hall Series
    • Inside the Lab
  • Get Involved
    • Get Recognized
    • Receive Awards
    • Serve Your Community
    • Center for Global Health
    • Serve Your Profession
    • Partners in Cancer Diagnosis
    • Institute for Science Technology & Public Policy
    • Choosing Wisely
    • Patient Champions
    • Discover Opportunities
    • Apply to Volunteer
    • Ambassadors
    • ASCP Mentorship Program
  • Careers
    • Find a Job
    • Post a Job
    • Learn About Careers
    • Discover Fellowships
    • Work at ASCP
  • About ASCP
    • Our Mission
    • Supporting Our Members
    • Our Community Efforts
    • ASCP Foundation
    • Contact ASCP
    • Media Relations
  • Board of Certification
    • Get Credentialed
    • Stay Credentialed
    • Verify Credentials
    • Program Directors
    • About BOC
    • Apply Now/Check Status/Update Info
    • Manage Your BOC Account
    • Declaration & Complete CMP
  • News
    • ePolicy News
Chicago (Headquarters)
33 West Monroe Street, Suite 1600, Chicago, IL 60603

Privacy Policy 

Terms of Use

Follow Us

Copyright ©2021 by American Society for Clinical Pathology. All Rights Reserved.