Update on COVID-19 Laboratory Reporting Requirements

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the HHS Lab Data Reporting Guidance released on June 4, 2020 require every COVID-19 testing site to report specific data elements for every test (e.g., molecular, antigen,…

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CDC updates the LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services On Friday, July 24, the CDC updated the LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests to include new data elements in the “LOINC Mapping” tab: Testkit Name ID Testkit Name ID Type LOINC…

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CDC publishes new interim guidance for use of pooling procedures for SARS-CoV-2 diagnostic, screening, and surveillance testing

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services View the guidance here. Online resources: Frequently Asked Questions about Coronavirus for Laboratories Clinical Laboratory COVID-19 Response Weekly Calls CDC’s Laboratory Outreach Communication System (LOCS) COVID-19 Information for Laboratories CDC COVID-19 website Register for CDC Health Alert…

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FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboaratory Services The US Food and Drug Administration (FDA) recently granted an Emergency Use Authorization (EUA) amendment, authorizing an update to the Instructions for Use (IFU) of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This update includes the addition of…

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