COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [Read more...]
Tool: Mandatory COVID-19 Vaccination Policy
January 14, 2021
It behooves you to ensure that lab workers get vaccinated against COVID-19 to protect not only themselves but also co-workers, patients and others at your facility. But what if workers neglect or just … [Read more...]
Tool: Voluntary COVID-19 Vaccination Policy
January 14, 2021
It behooves you to ensure that lab workers get vaccinated against COVID-19 to protect not only themselves but also co-workers, patients and others at your facility. But what if workers neglect or just … [Read more...]
Tool: Lab Worker’s Acknowledgement of Decision to Decline COVID-19 Vaccination
January 14, 2021
It behooves you to ensure that lab workers get vaccinated against COVID-19 to protect not only themselves but also co-workers, patients and others at your facility. But what if workers neglect or just … [Read more...]
FDA Watch
Agency Greenlights First Over-the-Counter, At-Home COVID-19 Testing Kit
January 10, 2021
Nearly 250 COVID-19 diagnostic tests have gotten Emergency Use Authorization (EUA) from the FDA since the pandemic started. Almost all of them have been prescription products. In addition, 25 test … [Read more...]
FDA Watch
Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit
January 6, 2021
Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for … [Read more...]
Consumer Fraud
OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams
January 6, 2021
Pharma companies, diagnostics manufacturers, labs and other parts of the healthcare industry have done a commendable job in pivoting in response to the current public health industry. Sadly, it seems … [Read more...]
Compliance Perspectives
Can You Require Lab Workers to Get the COVID-19 Vaccination?
January 6, 2021
Although it’s clearly a positive development for the world at large, the almost miraculous emergence of a vaccine for COVID-19 in less than a year poses legal challenges for employers in general and … [Read more...]
Emerging Tests
New Collaboration Seeks to Develop Handheld Breathalyzer Test for COVID-19
January 6, 2021
A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a major breakthrough in the effort to contain the spread of the virus. That … [Read more...]
Inside the Lab Industry
Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market
January 6, 2021
What COVID-19 antigen assays lack in accuracy with regard to RT-PCR testing is offset by their speed, low cost and scalability. In the long term, these advantages make point-of-care COVID-19 antigen … [Read more...]
