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FDA Warning: the E25Bio COVID-19 DART Test Should Not Be Used
Vidcast: https://youtu.be/mbafxXz_Ksk
The FDA is trumpeting a rare warning to consumers not to use the E25Bio COVID-19 Direct Antigen Rapid Test or DART. This test has not been authorized, cleared or approved by the FDA for sale and distribution in the US despite false labeling suggesting that it has been FDA authorized. This product may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.
The FDA is concerned that these test kits may yield false and misleading results as the E25Bio company has not provided the FDA with data that confirms the test’s accuracy. The FDA is also concerned that the instructions accompanying these test kits instruct users to collect samples from the throat by thrusting the swab through the nose into the upper throat or swabbing the middle portion of the throat through the mouth. Such self-collection may be hazardous.
This FDA warning will be embarrassing to MIT, the Mass. Institute of Technology as the E25Bio Co. is an MIT spinoff started by Professor Lee Gehrke and research scientist Irene Bosch, both of MIT’s Institute for Medical Engineering and Science.
Those who used this test kit and depended upon the results should retest with an FDA authorized rapid antigen test or with a PDR Covid test. Those who feel that they may have injured their noses or throats using the collection swab as directed should check with their providers.
Those with further questions may call the FDA’s Division of Industry and Consumer Education at 1-800-638-2041 or 1-301-796-7100.
https://content.govdelivery.com/accounts/USFDA/bulletins/3090e66
https://energy.mit.edu/news/mit-tata-center-startup-e25bio-produces-15-minute-tests-for-covid-19/
#CoVid #antigentest #FDA #approval #falsenegative #falsepositive #warning
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By Howard G. Smith MD, AM
Vidcast: https://youtu.be/mbafxXz_Ksk
The FDA is trumpeting a rare warning to consumers not to use the E25Bio COVID-19 Direct Antigen Rapid Test or DART. This test has not been authorized, cleared or approved by the FDA for sale and distribution in the US despite false labeling suggesting that it has been FDA authorized. This product may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.
The FDA is concerned that these test kits may yield false and misleading results as the E25Bio company has not provided the FDA with data that confirms the test’s accuracy. The FDA is also concerned that the instructions accompanying these test kits instruct users to collect samples from the throat by thrusting the swab through the nose into the upper throat or swabbing the middle portion of the throat through the mouth. Such self-collection may be hazardous.
This FDA warning will be embarrassing to MIT, the Mass. Institute of Technology as the E25Bio Co. is an MIT spinoff started by Professor Lee Gehrke and research scientist Irene Bosch, both of MIT’s Institute for Medical Engineering and Science.
Those who used this test kit and depended upon the results should retest with an FDA authorized rapid antigen test or with a PDR Covid test. Those who feel that they may have injured their noses or throats using the collection swab as directed should check with their providers.
Those with further questions may call the FDA’s Division of Industry and Consumer Education at 1-800-638-2041 or 1-301-796-7100.
https://content.govdelivery.com/accounts/USFDA/bulletins/3090e66
https://energy.mit.edu/news/mit-tata-center-startup-e25bio-produces-15-minute-tests-for-covid-19/
#CoVid #antigentest #FDA #approval #falsenegative #falsepositive #warning