FDA publishes performance data for COVID-19 tests

By LabPulse.com staff writers

September 16, 2020 -- The U.S. Food and Drug Administration (FDA) published comparative performance data for about 55 COVID-19 molecular diagnostic tests. The data show the limit of detection of the tests against an FDA standardized sample panel.

The lower the limit of detection, the smaller amount of viral material in a sample, which is an indication of a more sensitive test. However, the data do not show a specific test's sensitivity, so it cannot be used alone to determine whether a test should be authorized. Instead, it gives labs and healthcare providers a resource to compare the relative performance of available tests, according to the FDA.

Test developers were required to assess the performance of their tests against the FDA reference panel as a condition of receiving their emergency use authorizations (EUA). The approximately 150 developers who were given reference panels were not told the amount of viral material in the FDA's samples to ensure accuracy.

Top companies earn 80% of revenue in IVD market
Most of the revenue in the IVD market is generated by fewer than 20 companies, according to a recent report by IVD market research firm Kalorama Information,...
FDA grants DetectaChem EUA for mobile COVID-19 test
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to DetectaChem for its mobile COVID-19 test kit.
Real-world data project will help FDA assess COVID-19 diagnostics
The U.S. Food and Drug Administration (FDA) plans to use real-world data to evaluate and foster development of COVID-19 molecular and antibody tests through...
FDA issues COVID-19 digital pathology device guidance
The U.S. Food and Drug Administration (FDA) has issued a guidance document regarding the use of remote digital pathology devices during the COVID-19 crisis.

Copyright © 2020 LabPulse.com

Last Updated ls 9/21/2020 8:29:55 AM

Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.