FDA releases performance data for COVID-19 molecular diagnostic tests

Sep 16, 2020 - 03:13 PM
FDA product update

The Food and Drug Administration yesterday released comparative performance data for 55 COVID-19 molecular diagnostic tests.

Test developers are required to assess their test’s performance against a reference panel of viral samples to receive emergency use authorization.

In the data, a lower product LoD (limit of detection) indicates a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. FDA plans to update the data as it receives additional results to help inform laboratories, health care providers and patients about the relative performance of available tests.

In other news this week, FDA awarded a research contract to the University of Liverpool and global partners to sequence and analyze SARS-CoV-2 and other coronavirus samples to help inform the real-time performance of molecular-based diagnostics.

Related News Articles

Headline
AHA responds to FDA request for information on AI-enabled medical devices
The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
Headline
Permanent recall issued for Baxter ventilation system
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
CDC data shows rise in flu, COVID-19 cases across states 
Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19…
Headline
Recall issued for mislabeled potassium chloride
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…
Headline
Study finds flu, COVID-19 infection temporarily raises risk of heart attack, stroke 
A study published Oct. 30 by the American Heart Association found that people have an elevated risk of heart attack and stroke following flu and COVID-19…
Headline
CDC adopts ACIP recommendations for COVID-19, chickenpox vaccines
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…