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Coronavirus Resources for Labs

An illustration of the 2019 novel coronavirus.

           Image credit: CDC


AACC has gathered essential information and resources to help laboratories prepare for coronavirus disease 2019 (COVID-19) testing—and to stay prepared for when new infectious diseases inevitably emerge in the future.

AACC COVID-19 Testing Directory

New item icon For Healthcare Professionals
The AACC COVID-19 Testing Directory is a resource for healthcare professionals seeking access to clinical laboratory testing services for SARS-CoV-2. The Directory is also a resource for laboratory medicine professionals to connect and collaborate.

Go to the Directory




AACC
Advocacy
COVID-19
Science & Education
General Outbreak
Preparedness

AACC Advocacy

New item icon AACC Applauds Senate for Updating Legislation to Ensure All Patients Have Access to COVID-19 Testing

MAR.26.2020 - The Senate responded to AACC's concerns and revised the CARES Act to ensure that it provides insurance coverage for all COVID-19 tests, regardless of whether they are performed under an FDA EUA.

Read AACC’s Statement

AACC Urges Congress to Ensure All COVID-19 Tests Are Covered by Insurance After New FDA Guidance

MAR.17.2020 - AACC remains concerned that the Families First Coronavirus Response Act does not provide coverage for COVID-19 tests unless the tests are performed under an FDA Emergency Use Authorization.

Read AACC’s Press Release

Families First Coronavirus Response Act Would Prohibit Insurers from Paying for Some COVID-19 Tests

MAR.14.2020 - AACC supports Congress's work on the Families First Coronavirus Response Act, but is asking Congress to fix language that could lead to surprise bills for COVID-19 tests performed in accordance with FDA policy but before the agency has completed review.

Read AACC’s Statement

New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing

MAR.6.2020 - As the COVID-19 outbreak grows, lawmakers released a bill that promotes duplicative, costly federal regulation of laboratory-developed tests. AACC is urging Congress not to act on this bill until its impact on healthcare can be evaluated.

Read AACC’s Press Release

AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing

MAR.2.2020 - AACC thanks the FDA for allowing CMS-certified labs to test for coronavirus prior to FDA approval. AACC will continue to work with the agency to ensure patients receive timely, accurate testing.

Read AACC’s Statement

AACC Calls on FDA to Allow Clinical Labs to Develop Their Own Tests for Coronavirus

FEB 28.2020 - A spike in coronavirus cases could overwhelm public health laboratories and delay patient care. To ensure access to essential testing, AACC is urging FDA to allow all qualified clinical laboratories to develop coronavirus tests without going through FDA review.

Read AACC’s Letter to FDA




COVID-19 Science and Education

Free Course on COVID-19 from AACC Learning Lab

AACC developed this content with leading scientists as part of AACC Learning Lab on NEJM Knowledge+. The free course covers COVID-19 transmission, complications, diagnosis, and more.

View the Course External Link


The SARS-CoV-2 Outbreak: Diagnosis, Infection Prevention, and Public Perception

Experts across the globe from clinical laboratories, public health laboratories, infection control, and the diagnostic industry share their views on the diagnosis and control of SARS-CoV-2.

Read the Clinical Chemistry Q&A External Link


Pearls of Laboratory Medicine: Coronavirus Disease 2019 (COVID-2019)

In this video, Giuseppe Lippi of the University Hospital of Verona, Italy, provides an overview of Coronavirus Disease 2019 (COVID-19).

Watch the English Video External Link

Watch the Chinese Video External Link


Clinical Chemistry Podcast: Why Clinical Labs Are Essential to Containing COVID-19

Dr. Matthew Binnicker gives an update on the coronavirus outbreak and discusses what is needed to bring this global epidemic under control. This podcast is in English and Chinese.

Listen to the Podcast


Emergence of Novel Coronavirus Disease and the Importance of Diagnostic Testing

Dr. Matthew Binnicker, a virology expert from the Mayo Clinic, discusses why partnership between clinical laboratories, public health agencies, and industry is essential to controlling this outbreak.

Read the Clinical Chemistry Opinion External Link

Two New Rapid Coronavirus Tests Could Play a Key Role in Efforts to Contain Growing Epidemic

Research in AACC’s Clinical Chemistry journal shows that two new tests accurately diagnose coronavirus infection in about 1 hour. These tests could play a critical role in halting this deadly outbreak by enabling healthcare workers to isolate and treat patients much faster than is currently possible.

Read the Clinical Chemistry Study External Link


Clinical Chemistry Podcast: Molecular Diagnosis of a Novel Coronavirus

Dr. Leo Poon of the University of Hong Kong gives expert insight into the 2019 novel coronavirus, and discusses the new molecular diagnostic assays his team has developed to detect and quantify this virus. This podcast is in English and Chinese.

Listen to the Podcast

Racing Towards the Development of 2019 Novel Coronavirus Diagnostics

The sensitive and specific detection of this virus is an important part of the global healthcare response to this outbreak.

Read the Clinical Chemistry Editorial External Link




General Outbreak Preparedness

Are We There Yet? Laboratory Preparedness for Emerging Infectious Diseases

Experts in the field discuss the roles and responsibilities of labs in responding to highly infectious diseases, and the burden of ongoing readiness for rare events.

Read the Clinical Chemistry Q&A External Link

Climate Change is Shifting the Course of Infectious Diseases

As climate change and other factors such as globalization and urbanization drive the spread of infectious diseases, clinical laboratorians should expect to be on the front lines whenever a new infectious disease occurs in an unexpected place.

Read the CLN Article

Predicting the Next Outbreak

With new tools at their disposal, researchers are learning about pathogens more quickly. But even better tools and more funding are needed, experts argue, while also cautioning that predicting the next pandemic is no exact science.

Read the CLN Article

Key Resources


Interactive Map of the Outbreak

Snapshot of coronavirus interactive map - click to visit

The HealthMap team at Boston Children’s Hospital has created a map of all the publicly reported coronavirus cases around the world. This map also automatically updates in real time to include new cases as they arise.

View Map External Link





Food and Drug Administration

Contact FDA: If you are trying to obtain an EUA for a COVID-19 test, send all comments and questions to CDRH-EUA-Templates@fda.hhs.gov.

You can also report issues with FDA-authorized COVID-19 tests or related materials by calling 1-888-INFO-FDA.

Other FDA resources and news:

Centers for Disease Control and Prevention

National Institutes of Health

In response to questions about turnaround time for laboratories to acquire positive control RNA, AACC has confirmed that the NIH Biodefense and Emerging Infections Research Resources Repository is prioritizing SARS-CoV-2 and anticipates a 12-72 hour turnaround.

Centers for Medicare and Medicaid Services


 

Discuss COVID-19 Testing With Other Lab Professionals

Joint the conversation on AACC Artery—AACC’s online member community. Current COVID-19 Artery discussions include:

COVID-19 Serologic Diagnostics

COVID-19 Biochemical/Hematologic Parameters

Limited Test Menu Planning