FDA Changes Storage Requirements for Pfizer COVID-19 Vaccine, Facilitating Faster and More Widespread Use
New storage requirement for Pfizer vaccine makes it easier for clinical laboratory personnel to access vaccine.
FDA Issues New Guidance for Test Developers on How to Plan for Genetic Variants
Toward the performance of diagnostic tests, three main components are addressed by this new guidance.
Over $23 Million of COVID-19 Tests May Go to Waste in Hawaii as Large Volumes of Tests are Set to Expire
How the state plans to address potential waste of COVID-19 tests.
New Jersey Laboratory Sues Thermo Fisher, Alleging Problems With COVID-19 Testing Technology
Notice of complaint filed: TaqPath COVID-19 Combo Kit
Emerging SARS-CoV-2 Mutations: Impact on TaqPath Assay Performance and its Clinical Implications
Attend this webinar and learn the important clinical implications (epidemiological, prognostic, and predictive) of new COVID-19 “variants of concern,” the importance of early detection of these variants, and steps your lab can take to confidently detect the COVID-19 virus with a very high degree of specificity and sensitivity, given new variants.
First Study to Ever Deliberately Infect Humans With SARS-CoV-2 Set to Provide Valuable Information About Viral Load
This new SARS-CoV-2 study carries risks and controversy.
White House Announces Over $1.6 Billion to Increase Availability of COVID-19 Testing
New federal funding for pandemic response moves in three directions.
FDA Issues EUA for Point-of-Care COVID-19 PCR Test
Advancing Visby Medical’s PCR test, a new EUA for the “personal” PCR test expands its use to patient care settings operating under certain certificates.
New Research Identifies Which Point-of-Care COVID-19 Tests Meet WHO’s Target Product Profiles
Findings of new research that focuses on the performance of rapid COVID-19 antigen and antibody tests.
Lessons One Clinical Laboratory Has Learned as It Passes Its One Millionth COVID-19 Test
Intermountain Healthcare Laboratories credit “adaptiveness” to achieving COVID-19 test milestone.