I dunno if anyone will not have heard, but the fancy Cue Health NAAT molecular #Covid test, with the handheld gizmo, has been revealed to be a near fraud. The FDA found that the company implemented non-approved changes to reagent formulations and device firmware post-EUA that will have significantly reduced the test’s accuracy.

In response to the FDA’s letter, the company elected to go out of business.

Don’t use these tests.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cue-health-inc-675673-05092024

#CueHealth #CovidIsNotOver #CovidTesting

Another one bites the dust 🪦

"The final nail in the coffin may have come on May 9, when the Food and Drug Administration told Cue that the agency had inspected its San Diego facility and found the company had changed its COVID-19 tests and that they now gave less reliable results. "

#biotech #CueHealth #COVID19

https://www.sfgate.com/tech/article/cue-health-layoff-every-worker-19474324.php

At the suggestion of others, I switched to Aptitude's Metrix for NAAT Covid19 testing (Thank you to those who suggested it!!). It's a little more fiddly as far as parts and process, but I'll take that over "false negatives" and "closing down".

https://stillcoviding.ca/en/news/san-diego-covid-19-testmaker-cue-health-is-shutting-down/

#CovidIsNotOver #CovidTesting #Covid #covid19 #CueHealth #Cue

ooh boy... #covid19 #covidtesting #CueHealth

https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication

So we're going to need to stop using our Cue Health Covid tests until they sort out stuff...

https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication

I'm not really comfortable tossing my tests yet, but at our house, we're going to move to two-RATs-in-48-hours testing.

Sucks. A lot.

#CueHealth #Cue #CovidTests #Covid19 #Covid

Nothing like coming out of self-imposed 5 day quarantine after a trip and seeing the Cue NAAT COVID-19 test say negative. It's not fun, but honestly it beats knowing you brought shit home to the rest of your household. And since there were two of us this time, it was less lonely.

#LivingWithCovid #CovidIsNotOver #CueHealth