Thread by @DrEricDing

⚠️FALSE NEGATIVES—The FDA has identified **3** COVID-19 molecular tests that are not able to detect the #Omicron variant & warned that diagnostics from 📌Applied DNA Sciences, 📌Meridian Bioscience & 📌Tide Laboratories will return false negative results.
medtechdive.com/news/fda-updat…

2) FDA noted on its website that Tide's DTPM COVID-19 RT-PCR test is currently being performed in the U.S. by more than 30 laboratories, providing the names and cities where the labs are located, but added that the diagnostic "is not believed to be used for high volume testing."

3) In the case of Meridian Bioscience's Revogene SARS-CoV-2 test, FDA said that the company has not yet distributed the diagnostic and does not intend to do so inside or outside the U.S. until the issue is resolved.

4) No information on the current use of Applied DNA Sciences' Linea COVID-19 Assay Kit is provided by the agency's website.

The Applied DNA Sciences is the first two-viral target assay to fail to detect omicron. Meridian's and Tide's diagnostics are both single-target tests.

5) FDA updates its list of tests that are problematic for variants here on this website— so far it’s just these 3 tests against #Omicron. Hope it doesn’t expand. fda.gov/medical-device…