Nearly a dozen at-home COVID-19 antigen test kits have received Emergency Use Authorization (EUA) from the US Food and Drug Administration. And that begs a crucial question: Just how user-friendly are … [Read more...]
COVID-19 Testing
Just How User-Friendly Are Current Rapid At-Home COVID-19 Test Kits?
January 20, 2022
Compliance Perspectives
What to Do If a Lab Employee Defies Your Mandatory Vaccination Policy
December 1, 2021
Mandatory vaccination policies have become a touchstone issue for not just labs but employers in just about every industry. And all of this begs a question of crucial importance: What should you do … [Read more...]
TESTING ADVICE
AACC Doubles Down on Not Using CT Values to Evaluate Performance of SARS-CoV-2 PCR Tests
November 29, 2021
Laboratories and health care providers should not use cycle threshold (CT) values to measure the performance of polymerase chain reaction (PCR) tests for SARS-CoV-2. That was the advice of the … [Read more...]
FDA Watch
Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs
October 5, 2021
On Aug. 2, 2021, the U.S. Food and Drug Administration (FDA) published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here is a quick briefing of … [Read more...]
COVID-19
White House Rolls Out Plan to Increase Nationwide Rapid, Point-of-Care COVID-19 Testing
September 21, 2021
Much has changed since the spring when Abbott, LabCorp, Quest and other major COVID-19 testing labs were demobilizing their coronavirus infrastructure and pivoting to normal business. The surge of new … [Read more...]
Tool
Model Lab Workplace Vaccine Passport Policy
September 8, 2021
Although courts have yet to weigh in on the issue, guidelines from the US Equal Employment Opportunity Commission and other regulatory agencies indicate that employers may implement vaccine passports … [Read more...]
Compliance Perspectives
The 5 Things to Do When Implementing a Vaccine Passport Policy at Your Lab
September 6, 2021
Like many labs and other health providers, you might have been undecided about whether to mandate that your employees get the COVID-19 vaccine. However, now that the FDA has fully approved a … [Read more...]
FDA Watch
Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees
September 6, 2021
Although the FY 2022 fees increase is less than half of last year’s increase, applying to the US Food and Drug Administration (FDA) for premarket review of medical devices will still be more expensive … [Read more...]
Testing Trends
FDA Regulation of COVID-19 Testing Enters a New Phase
August 26, 2021
The public health emergency (PHE) is still in effect but the honeymoon has ended. The leniency that the U.S. Food and Drug Administration (FDA) has displayed toward COVID-19 tests and test makers … [Read more...]
Clinical Guidelines
AHA Calls for Individualized Approach to Pediatric Cardiovascular Genetic Testing
August 23, 2021
Genetic testing of children can play a key role in determining a child’s risk of developing heritable cardiovascular disease. But testing should be limited to children with a high likelihood of … [Read more...]
