FDA Issues Updated Guidance for Convalescent Plasma, Outlines How Donors and Plasma Should Be Tested

Points of interest from the US Food and Drug Administration’s November 2020 update to investigational COVID-19 convalescent plasma guidelines.
New Tool by Cleveland Clinic and Epic Can Predict Which Patients Are Likely to Test Positive for COVID-19

Predictive tool for COVID-19 highlights the advantages of coupling machine learning with laboratory data.
FDA Issues First EUA for At-Home COVID-19 Test

More about the first at-home COVID-19 test, a rapid, single-use molecular diagnostic test kit for the qualitative detection of SARS-CoV-2 RNA from self-collected nasal swab specimens.
With COVID-19 Testing Needed for Travel, Fake Negative COVID-19 Tests Emerge as a Problem

How clinical laboratories can respond to a black market for fake negative COVID-19 test results.
FDA Issues Three EUAs for At-Home Collection COVID-19 Tests

Tests of interest as part of new FDA-allowed at-home specimen collection options.
Lessons Learned from New York City COVID-19 Contact Tracing Program

Three strategies that benefited the community’s contact tracing program.
Special Report Answers Numerous Questions About Developing a COVID-19 Employee Testing Program

Essential guidance on legal, risk management, regulatory, and compliance issues for clinical laboratories and employers that are partnering for employee COVID-19 testing.
COVID-19 Testing May Increase Threefold Over Flu Season, Experts Project

Two factors influencing demand for COVID-19 testing during flu season, according to recent analysis.
As Flu Season Approaches, FDA Provides Clinical Laboratories Flexibility to Modify Influenza and RSV Tests

Breakout of examples of modifications that will and will not be permitted with influenza and RSV clinical lab tests during the public health emergency.
Billing Expert Identifies Reimbursement Hurdles That Clinical Laboratories are Facing and How to Overcome Them

Interview with Mick Raich of Vachette Pathology on evolving payer and reimbursement rules and resolving billing and reimbursement difficulties for COVID-19 testing.