COVID-19 Testing

Just How User-Friendly Are Current Rapid At-Home COVID-19 Test Kits?

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...]

Compliance Perspectives

What to Do If a Lab Employee Defies Your Mandatory Vaccination Policy

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

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

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

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

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

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

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

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

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...]


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