Coronavirus Resource and News Center
There are multiple posted messages to date concerning the novel Coronovirus outbreak (now named COVID-19), with more messages to be added. For up to the date information from the CDC, click here.
In the News
12/21/2020
NILA Comments on CMS Rules for Posting COVID-19 Pricing Data (NILA News Story)
12/2/2020
Lab Group Letter to Biden Transition Team regarding COVID-19 Supply Shortage
11/21/2020
FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
11/20/2020
FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
11/19/2020
FDA Authorizes Drug Combination for Treatment of COVID-19
11/18/2020
Waste Management Guidance for SARS-CoV-2 Point-of-Care Testing
11/17/2020
CDC Releases 6th Edition of Biosafety in Microbiology and Biomedical Laboratories
11/16/2020
FDA Update on FAQs on Testing for SARS-CoV-2
11/12/2020
CMS IQCP Clarification for EUA Tests
11/11/2020
CMS Takes Steps To Ensure Medicare Beneficiaries Have Wide Access To COVID-19 Antibody Treatment
11/3/2020
CDC Updates Specimen Collection Guidelines for COVID-19
11/1/2020
Join the Next Clinical Laboratory COVID-19 Response Call on today, November 2 at 3:00 PM EDT
10/15/2020
CDC Publishes New Web Page on Point-of-Care Testing for COVID-19
10/2/2020
FDA Updates the SARS-CoV-2 Reference Panel Comparative Data
10/1/2020
CSTE Posts New Electronic Laboratory Reporting Points of Contact for COVID-19
CMS Releases New Laboratory Quick Start Guide for CMS CLIA Certification
9/23/2020
Lab Advisory: LOINC In-Vitro Diagnostic (LIVD) Codes for SARS-CoV-2 Antigen Tests
9/22/2020
CDC, APHL and CSTE Standardized ELR Flat File
9/18/2020
CDC Updates Guidance on Testing for SARS-CoV-2
9/9/2020
U.S. FDA Update - FAQs on Testing for SARS-CoV-2
9/3/2020
CMS Issues New Surveyor Guidance for SARS-CoV-2 Laboratory Test Result Reporting
8/31/2020
Join the Next Clinical Laboratory COVID-19 Response Call Today, August 31 at 3:00 PM EDT
8/29/2020
CMS Publishes New CLIA FAQs
8/26/2020
CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting
8/24/2020
FDA FAQ Update: New Information On Testing For SARS-CoV-2
8/18/2020
NILA Applauds CRL For Launching Saliva-Based COVID-19 Test
8/5/2020
CDC Updates Reporting FAQs for COVID-19 Testing
7/31/2020
Update on COVID-19 Laboratory Reporting Requirements
HEALS Act Introduced - Read NILA's Summary
July 28, 2020
FDA Issues COVID-19 Testing and Policy Updates
CMS Updates Data on COVID-19 Impacts on Medicare Beneficiaries
July 24, 2020
CDC Releases New Test Pooling Guidance for SARS-CoV-2
July 23, 2020
CDC Publishes Primers and Probes for Research Use Only SARS-CoV-2 Multiplex Assay
CDC Releases New Test Pooling Guidance for SARS-CoV-2
July 22, 2020
Update on Laboratory Reporting Guidance for SARS-CoV-2
July 18, 2020
FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel
July 16, 2020
FDA Releases New Information On Testing For SARS-CoV-2
July 11, 2020
CDC Publishes New General Laboratory Safety Guidance
July 10, 2020
Laboratory Stakeholders Ask Administration To Improve Access To Testing Supplies
July 9, 2020
CDC Multiplex Assay Receives Authorization from FDA
July 8, 2020
Letter to VP Pence from NILA and other organizations addressing demand for COVID-19 testing supplies
July 7, 2020
FDA Letter Warns Of False Positive Results With BD SARS-CoV-2 Reagents For The BD Max System
July 1, 2020
DOT Issues Safety Notice for Transportation of COVID-19 Diagnostic Samples
June 29, 2020
FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2
June 26, 2020
NILA Letter to Senator Alexander Regarding Future Pandemics
June 22, 2020
Join Today's Clinical Laboratory COVID-19 Response Weekly Call on Monday, June 22 at 3:00 PM EDT
June 20, 2020
FDA Updates Website, Issues Warning Letters, and Revokes Chembio EUA
June 19, 2020
Detection of Ciprofloxacin-resistant, β-lactamase-producing Neisseria meningitidis Serogroup Y Isolates
June 12 ,2020
CDC Updates Laboratory Biosafety Guidelines and Questions & Answers
Join the Next Clinical Laboratory COVID-19 Response Weekly Call on Monday, June 15 at 3:00 PM EDT
June 10, 2020
FDA Posts Information from Independent Evaluations of COVID-19 Serological Tests
June 8, 2020
Join the Next Clinical Laboratory COVID-19 Response Weekly Call on Monday, June 8 at 3:00 PM EDT
June 6, 2020
HHS Issues New CARES Act Guidance
June 1, 2020
Lab Alert: Molecular Transport Media (MTM) and Cyanide Gas
May 29, 2020
FDA responds to April 20 letter regarding serology testing
May 27, 2020
CDC Releases Interim Guidance for Coronavirus Disease (COVID-19) Antibody Testing
May 22, 2020
FDA Removes Several COVID-19 Antibody Tests and Provides Additional Information
May 11, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript
May 9, 2020
New COVID-19 Data Tracker Website for Laboratories
May 7, 2020
Updated LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Test Results
May 6, 2020
CDC Posts New Information about Serology Testing for COVID-19
CMS Issues Updated COVID-19 Frequently Asked Questions about Medicare Fee-for-Service Billing
May 4, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript
FDA Releases Revised Policy for COVID-19 Serology Testing
May 2, 2020
CDC Releases Test Code Mapping Guide
April 28, 2020
Release Of COVID-19 Testing Overview And Testing Blueprint
April 27, 2020,
CDC Weekly Call with Clinical Labs Audio and Transcript
April 20, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript
AAB/NILA letter to FDA and CMS regarding COVID-19 testing
April 15, 2020
CMS Increases Medicare Payments For COVID-19
April 13, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript
April 10, 2020
AAB/NILA Response Letter to Senators Duckworth, Durbin, and Markey, Regarding COVID-19
April 9, 2020
Laboratory Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
April 6, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript
April 1, 2020
Laboratory Advisory: Updated Clinical Guidance on Testing Persons for Coronavirus Disease (COVID-19)
March 30, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript
Trump Administration Provides Financial Relief For Medicare Providers
Trump Administration Engages America’s Hospitals In Unprecedented Data Sharing
March 27, 2020
The CARES Act Provides Temporary, But Not Immediate Relief To Clinical Laboratories
March 26, 2020
CMS Issues CLIA Guidance and FAQs for Laboratories During the COVID-19 Pandemic
March 23, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript
March 21, 2020
CDC Posts New Standard Operating Procedure for Creating Viral Transport Media
March 20, 2020
NILA's COVID-19 Stimulus Request Letter to Capitol Hill
March 19, 2020
CDC to Convene Clinical Laboratory COVID-19 Response Weekly Calls Beginning on Monday, March 23, 2020 at 3:00 PM ET
March 17, 2020
Update On AAB COVID-19 Precautions
Change to Result Interpretation for CDC EUA Assay
March 14, 2020
Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease (COVID-19)
March 13, 2020
FDA FAQs on Diagnostic Testing for SARS-CoV-2
March 12, 2020
COVID-19 Lab Letter to Vice President (PDF)
March 10, 2020
CDC Updated Guidance On Testing Persons For Coronavirus Disease 2019 (COVID-19)
FDA Releases FAQs On Diagnostic Testing For SARS-CoV-2 (COVID-19)
U.S. Department Of Labor Offers Guidance For Preparing Workplaces For Coronavirus
March 9, 2020
Coronavirus testing rollout marred by confusion and false starts (Yahoo! News)
March 6, 2020
Federal Register Notice Regarding Policy For Labs Performing Coronavirus Tests
Virus Testing Questions Remain After HHS Briefs House
March 5, 2020
CMS Announces New HCPCS Code For Coronavirus Lab Tests
Lawmakers Introduce Legislation To Expand Nation’s Diagnostic Testing Capabilities
Senator Murray's (D-WA) Letter to Vice President Mike Pence
March 4, 2020
COVID-19 Public Health Reporting for Laboratories that Develop or Use Laboratory Developed Tests with Intent to Obtain EUA
CMS Memo on Suspension of Survey Activities
March 2, 2020
FDA Guidance To Develop Novel Molecular Diagnostic Tests For SARS-CoV-2
Laboratory Biosafety COVID-19 Frequently Asked Questions
February 27, 2020
Criteria to Guide Evaluation of Person Under Investigation (PUI) for COVID-19
February 25, 2020
Update: Public Health Response to the Coronavirus Disease 2019 Outbreak
February 24, 2020
Public Health Response to the Coronavirus Disease 2019 Outbreak
February 21, 2020
Frequently Asked Questions about Biosafety and COVID-19
February 18, 2020 (from CRB)
Important FDA Notification Regarding Coronavirus
February 12, 2020
Lab Update: Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV)
February 12, 2020 (from AAB)
CMS Update On Coronavirus Assay
February 8, 2020
Lab Update: Updated Information about the Emergency Use Authorization for the CDC 2019-nCoV RT-PCR Diagnostic Panel
February 7, 2020
Persons Evaluated for 2019 Novel Coronavirus
February 5, 2020
Lab Update: Information about Emergency Use Authorization for 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel
February 1, 2020
Lab Alert: Updated Specimen Submission Information for the 2019 Novel Coronavirus
January 29, 2020
Lab Advisory: Published Assay Information for the 2019 Novel Coronavirus (2019-nCoV)
January 22, 2020
The Basics: What We Know — and Don’t Know — About the Virus Spreading in China and Beyond
January 20, 2020
Lab Advisory: Outbreak of 2019 Novel Coronavirus (2019-nCoV) in Wuhan, China
