Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

COVID-19 Omicron Variant Could Cause False-Negative Results In Tide Labs Test, FDA Says

Executive Summary

The US FDA said this week that the DTPM COVID-19 RT-PCR Test made by Tide Laboratories LLC could give erroneous readings because of the latest coronavirus variant.

You may also be interested in...



FDA Says Another COVID-19 Test Thrown Off By Omicron Variant

The US FDA has added the Linea COVID-19 Assay Kit to its list of diagnostics that could produce false-negative results due to the most recent coronavirus mutation.

Another COVID-19 Diagnostic Impacted By Omicron Variant

The Revogene SARS-CoV-2 test from Meridian Bioscience could give false-negative results because of the latest coronavirus variant. The good news is that the diagnostic hasn’t been distributed in the US, the FDA says.

FDA’s ‘Clearly Very Concerned’ About Delta COVID-19 Variant, CDRH’s Shuren Says

US FDA device center director Jeff Shuren said on 22 July that the agency is worried about the Delta variant, but is taking the steps necessary to ensure that coronavirus diagnostics give accurate readings.

Related Content

Topics

UsernamePublicRestriction

Register

MT144819

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel