CDC Reverses Guidelines on Asymptomatic Testing for COVID-19, Potentially Increasing Test Volumes for Clinical Laboratories

The reversal of the asymptomatic testing guidelines may benefit clinical laboratories from a business standpoint moving forward.
CMS Releases New Resources for Clinical Laboratories Seeking Information About CLIA Certification During the Pandemic

A six-point primer to the new CMS clinical laboratory CLIA quick start guide released in September 2020.
Diagnostic Expert Weighs in on the Dangers of Allowing Research Staff to Perform COVID-19 Clinical Testing

Interview with Matthew J. Binnicker, PhD, on the potential negatives of resolving staffing shortages by using research scientists for clinical laboratory testing.
Many States Failing to Report Antigen-Based COVID-19 Test Results Appropriately

Four significant findings of a Kaiser Health News state antigen test survey.
FDA Authorizes First SARS-CoV-2 Antibody Test That Can be Performed at the Point of Care

With 47 COVID-19 antibody tests authorized for use under FDA EUA as of Sept. 24, 2020, only one is authorized as POC for fingerstick blood samples collected in patient care settings.
As Rollout of POC COVID-19 Testing Begins, One Antigen Test is Having Unexpected False-Positive Results

Clinical laboratory leaders need to be aware of situations where COVID-19 antigen tests may be inadequate.
Research Continues to Indicate the COVID-19 Pandemic May Have Started Earlier Than Initially Thought

Points of interest from new UCLA-University of Washington research attempting to trace hospital patients’ symptoms to earlier than thought COVID-19 cases.
FDA Publishes Comparative Performance Data for Some SARS-CoV-2 Diagnostic Tests

Lowest limit of detection noted.
CRISPR-Based COVID-19 Testing Technology Continues to Advance with Recently Announced Dartmouth Research Collaboration

Continued coronavirus research will provide more robust data about the efficacy of CRISPR-based technology as a new diagnostic testing method.
3 Major Moves Positioning Google Sister Company, Verily, to Reckon with Traditional Clinical Laboratories

Now an FDA EUA for Verily’s SARS-CoV-2 pooled testing that can test 12 samples at once—Google sister company’s clinical laboratory test leanings continue entry into market.