Public Health

U.S. Needs 200 Million COVID-19 Screening Tests Per Month to Reopen Safely, Says New Report

How many COVID-19 screening tests per month will it take for the U.S. to reopen safely? One new report estimates the number as around 200 million, which is far below the 25 million tests currently … [Read more...]

EUA

FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic

The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation … [Read more...]

PANDEMIC

Hospitals, Labs, LTCs Face Big Fines for Failing to Meet New CMS COVID-19 Test Daily Reporting Rules

Nursing and other long-term care (LTC) facilities have been a hotspot for COVID-19 infection since the public health emergency began. On Aug. 27, CMS issued a new Interim rule requiring LTC facilities … [Read more...]

Tool

Telecommuter Home Office Hazard Assessment & Inspection Checklist

While not an OSHA obligation, it’s highly advisable to take measures to protect the health and safety of telecommuting lab employees who work from home. How? By having employees seeking approval to … [Read more...]

LDTs

FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling

It’s not uncommon for the FDA to revise the Emergency Use Authorization (EUA) for a particular diagnostics test to permit a new clinical use. In most cases, these expansions don’t even get an official … [Read more...]

FDA Watch

Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks

Shortages of the nasopharyngeal swabs used to collect respiratory samples for reverse transcription polymerase chain reaction (RT-PCR) tests has impeded the efforts of laboratories to meet the … [Read more...]

DATA

UK Antibodies Prevalence Study Suggests that Minorities Contract COVID-19 at Disproportionately Higher Rates

Many have suggested that minority populations have suffered adverse effects from COVID-19 disproportionate numbers. An August study from the United Kingdom provides powerful evidence to support this … [Read more...]

Top of the News

Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing

Free COVID-19 testing is a powerful and very compelling policy. The problem, of course, is that somebody has to pay for coronavirus testing. And the insurance companies have been designated as that … [Read more...]

COVID-19

Laboratory Organizations Ask HHS for Permission to Focus Scarce Testing Resources on those in Medical Need

With no hope that manufacturers will pick up the slack and furnish the reagents, swabs, PPE and other desperately needed COVID-19 testing supplies before the end of the year, laboratories are in the … [Read more...]

LDTs

HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization

One of the unforeseen results of the coronavirus public health emergency has been to bring the perennial controversy over U.S. Food and Drug Administration (FDA) premarket regulation of laboratory … [Read more...]


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