Explanation of preanalytical issues with SARS-CoV-2 (COVID-19) testing in clinical laboratories and what to expect in the event of a second wave of infections in the fall.
FDA Issues Warning Letter to KBMO Diagnostics for Advertising Unauthorized At-Home SARS-CoV-2 Testing
Explanation of warnings issued to KBMO Diagnostics related to at-home COVID-19 testing.
Where to start when working on a laboratory developed test using next generation sequencing (NGS) technology for diagnosing SARS-CoV-2, according to Timothy Stenzel, MD, PhD.
At-home SARS-CoV-2 warning letters and implications for clinical laboratories and pathologists.
Clinical Laboratories May Be Affected by Health Insurers’ Push to Reduce Their Payment Obligations for COVID-19 Tests
Overview of complaints around COVID-19 test payment expectations and attempts to reduce health insurers’ legislative and regulatory requirements.
FDA Releases EUA Templates for Clinical Laboratories and Manufacturers Creating Tests for the Broad Screening of Asymptomatic Individuals
Selected quotes from Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health at the FDA on the June 16, 2020, updates to EUA templates.
In an exclusive interview, Frederick (Fritz) Kiechle, MD, PhD, explains how and why saliva has emerged as a sample type for detecting SARS-CoV-2, the coronavirus that causes COVID-19.
CDC Provides Additional Supporting Information on New Data Reporting Requirements for Clinical Laboratories
Four important statements from a June 8 CDC clinical laboratory call covering COVID-19 test data reporting requirements.
Start and Scale COVID-19 Testing with Essential Tools that Support the Business and Workflow of Your Lab
Take away from this webinar a clear understanding of how your lab can rapidly ramp up its COVID-19 testing, offer the right support for the right tests (RT-PCR, serology) and effectively serve physician customers, while maintaining adherence to security and compliance requirements.
Westgard QC Webinar Part 2 Points of Interest: Achieving High Confidence Levels in the Quality and Accuracy of COVID-19 Serology Tests
Pearls from the 90-minute educational webinar, “Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests,” presented June 11 and featuring James O. Westgard, PhD, and Sten Westgard.