Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test) Date Manufacturer(s) Test Receiving EUA July … [Read more...]

Current Issue of DTET

Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download DTET content: I agree that I am the the only person who is accessing my … [Read more...]

The Business of Testing

Pandemic Energizes Search for Genomics-Based Early PTSD Detection Diagnostics

COVID-19 is destroying not only lives and the economy but also mental health. The global pandemic is widely expected to result in a dramatic increase in post-traumatic syndrome disorder (PTSD) cases. … [Read more...]

Testing Strategy

COVID-19 May Spread via Fecal Matter & Not Just Respiratory Droplets

It is a truism that almost nobody questions. Because COVID-19 is a respiratory disease, diagnosis and discharge of patients from hospitals is based on respiratory specimens. However, a new analysis … [Read more...]

Diagnostic Breakthroughs

Researchers Develop Scalable Antibody Test to Detect COVID-19 Immunity

Scalable, accurate assays capable of not only COVID-19 detection but actual immunity to the virus will be critical for social distancing, virus surveillance and treatment. And now researchers at the … [Read more...]

Test Quality

Physicians Stress Urgent Need for COVID-19 Antibody Reference Testing Standard

Widespread COVID-19 testing is essential to safely reopen the US. While test availability has been the main focus, test accuracy may prove to be the bigger issue. If a test erroneously delivers a … [Read more...]

LDTs

FDA Sets the Bar on Specimen Pooling & Asymptomatic Screening for SARS-CoV-2 Test Development

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...]

FDA Watch

After Initial Resistance, Agency Warms to Home COVID-19 Testing

Back in March, the US Food and Drug Administration (FDA) stated that the newly liberalized clearance scheme it was deploying to expedite the COVID-19 diagnostic testing pipeline did not apply to … [Read more...]

Emerging Tests

FDA Pulls Back the Reins on Makers of Unproven Coronavirus Serology Assays

The U.S. Food and Drug Administration continues to struggle in its quest for a regulatory policy to unlock the potential of blood-based COVID-19 serology testing while reining in fraudulent marketing … [Read more...]

COVID-19 Serology Testing

Now Even the “Good” Tests Are Coming Under Fire

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...]


(-00000g2)