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

October 19, 2020
NILA Questions FDA Decision to Suspend EUAs for COVID-19 LDTs

Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

October 15, 2020
CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

CDC Publishes New Web Page on Point-of-Care Testing for COVID-19

October 7, 2020
NILA/AAB and Four Other Lab Groups Ask Pandemic Task Force to Address COVID-19 Supply/Reagent Shortages

October 5, 2020
NILA Members Report Continued Supply Shortages, Potential Increased COVID-19 Testing Capacity

Guidance for LOINC In-Vitro Diagnostic (LIVD) Code Selection for Laboratories Using Laboratory-Developed Tests

October 2, 2020
FDA Updates the SARS-CoV-2 Reference Panel Comparative Data

October 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

September 23, 2020
Lab Advisory: LOINC In-Vitro Diagnostic (LIVD) Codes for SARS-CoV-2 Antigen Tests

September 22, 2020
CDC, APHL and CSTE Standardized ELR Flat File

September 18, 2020
CDC Updates Guidance on Testing for SARS-CoV-2

September 9, 2020
U.S. FDA Update - FAQs on Testing for SARS-CoV-2

September 3, 2020
CMS Issues New Surveyor Guidance for SARS-CoV-2 Laboratory Test Result Reporting

August 31, 2020
Join the Next Clinical Laboratory COVID-19 Response Call Today, August 31 at 3:00 PM EDT

August 29, 2020
CMS Publishes New CLIA FAQs

August 26, 2020
CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting

August 24, 2020
FDA FAQ Update: New Information on Testing for SARS-CoV-2

August 18, 2020
NILA Applauds CRL for Launching Saliva-Based COVID-19 Test

August 16, 2020
CDC LOCS Lab Advisory: New COVID-19 Antigen Testing Guidance

CDC LOCS Lab Update: FDA Updates FAQs about Testing for SARS-CoV-2

CDC LOCS Lab Alert: Report False Negatives and False Positives from COVID-19 Testing & Review New Frequently Asked Questions

August 10, 2020
CDC Responds to NILA Request that Record Reporting Requirements for COVID-19 Tests be Reconsidered

August 5, 2020
CDC Updates Reporting FAQs for COVID-19 Testing

July 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
NILA Letter to HHS Secretary Azar Requests Delay in Implementation of Lab Data Reporting Guidance

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 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

June 10, 2020
FDA Posts Information from Independent Evaluations of COVID-19 Serological Tests

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 5, 2020
FDA Updates Policy about Serology Tests for COVID-19

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

May 1, 2020
CMS Issues Additional Guidance on SARS-CoV-2 Laboratory Testing

April 28, 2020
Trump Administration Releases COVID-19 “Testing Overview” and “Testing Blueprint”

April 27, 2020
CDC Weekly Call with Clinical Labs Audio and Transcript

April 24, 2020
NILA’s letter to CMS about reimbursement rates for antibody tests

April 22, 2020
NILA Releases White Paper on Importance of Proficiency Testing for COVID-19

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
Lab Advisory: Updated Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

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 7, 2020
Increased COVID-19 Specimen Collection Fees for SNF and Homebound Patients

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 Engages America’s Hospitals in Unprecedented Data Sharing

Trump Administration Provides Financial Relief for Medicare Providers

March 27, 2020
The CARES Act Provides Temporary, but Not Immediate Relief to Clinical Laboratories

March 26, 2020
Senate Passes Stimulus Package with Relief for Clinical Laboratories

CMS Issues CLIA Guidance and FAQs for Laboratories During the COVID-19 Pandemic

March 24, 2020
URGENT: NILA Members Call Your Senators Today

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

Discontinue Use of the A549/MV1LU Mix for Respiratory Viral Culture Panels and Review Updated Biosafety FAQs

March 20, 2020
NILA's COVID-19 Stimulus Request Letter to Capitol Hill

Supplies Needed for COVID-19 Testing

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
Change to Result Interpretation for CDC EUA Assay

March 15, 2020
Lab Advisory: Updated Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19)

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

Proper Handwashing Technique

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 NILA)
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