On June 16, the US Food and Drug Administration (FDA) issued new guidance addressing two key issues related to SARS-CoV-2 testing: validation processes for test pooling of samples for test development … [Read more...]
COVID-19 Serology Testing
Now Even the “Good” Tests Are Coming Under Fire
May 26, 2020
The inaccuracy of serology tests that detect antibodies to the SARS-CoV-2 virus has become an issue of mounting concern. Even though the lack of sensitivity and specificity of these tests is well … [Read more...]
FDA Watch
Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time
April 20, 2020
The US Food and Drug Administration (FDA) has taken a lot of heat for wasting precious time in responding to the COVID-19 emergency. While this criticism is fair, it is also true that the agency has … [Read more...]
Pandemic & Progress
First Saliva COVID-19 Test Secures FDA Approval
April 19, 2020
One of the toughest parts of COVID-19 laboratory testing is the sample collection process. A swab must be inserted into each nostril, one at a time, to the nasopharynx at the back of the nasal cavity, … [Read more...]
Emerging Tests
Serology Testing Critical to COVID-19 Survival & Post-Crisis Transition
April 19, 2020
There are two kinds of people who have SARS-CoV-2 antibodies in their systems: Those who are currently infected with COVID-19 (both symptomatic and asymptomatic), and those who were infected but have … [Read more...]
Point of Care
Are Rapid Immunodiagnostic Tests for COVID-19 Ready for Prime Time?
April 19, 2020
The success of treatment, quarantine and, ultimately, return to normalcy, all hinge on the development and dissemination of tests capable of not just accurate but rapid detection of COVID-19 … [Read more...]
Emerging Tests
How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed
March 24, 2020
The criticism leveled at the Food and Drug Administration (FDA) over the lack of diagnostic tests for COVID-19 in the U.S. belies the unprecedented speed with which new coronavirus tests are reaching … [Read more...]
FDA Watch
SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals
March 24, 2020
Key new U.S. Food and Drug Administration product approvals announced from mid-February 2020 through March 20, 2020 include emergency use authorization (EUA) for eight different commercial tests for … [Read more...]
FDA Watch
FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
March 23, 2020
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA … [Read more...]
