{"id":1601,"date":"2022-02-09T09:25:36","date_gmt":"2022-02-09T15:25:36","guid":{"rendered":"https:\/\/freecovidvaccination.com\/?p=1601"},"modified":"2022-02-09T09:25:36","modified_gmt":"2022-02-09T15:25:36","slug":"fda-warns-against-using-e25bios-covid-test-and-offers-alternatives","status":"publish","type":"post","link":"https:\/\/freecovidvaccination.com\/?p=1601","title":{"rendered":"FDA Warns Against Using E25Bio’s COVID Test and Offers Alternatives"},"content":{"rendered":"

A U.S. Food and Drug Administration (FDA) safety communication warns people not to use the COVID-19 Direct Antigen Rapid Test distributed by E25Bio as it is not authorized, cleared, or approved by the agency due to lack of transparency by the company. As a result, its distribution or use in the United States is not permitted.<\/p>\n

\"FDA\"
Courtesy of Alexandra_Koch (Pixabay CC0)<\/figcaption><\/figure>\n

The test may be marketed using its trade name, E25Bio SARS-CoV-2 Antigen Test Kit. However, since the company has not provided the FDA with sufficient data that demonstrate the test’s performance is accurate, the agency’s concern centers around the risk of false results. Additionally, the\u00a0 FDA learned the E25Bio COVID-19 Direct Antigen Rapid Test might have been sold directly to the public with instructions for collecting the sample that could result in grave injury when not administered by qualified professionals.<\/p>\n

Injuries could include: damaging the tonsils\/throat from the swab, potentially inducing vomiting, or pieces of the swab breaking off. In addition, the FDA warns that test swabs could be fragile and not appropriately designed for swabbing the nasopharyngeal (back of the throat) or oropharyngeal (middle part of the throat just beyond the mouth), which could cause a problem them to break.<\/p>\n

No reports of injuries, adverse health consequences, or death associated with this test have been reported to the FDA. Nonetheless, the agency calls for health care providers<\/a>, testing program organizers, the general public, including caregivers to use a different test instead. In addition, health officials are asking for any problems with the E25Bio COVID-19 Direct Antigen Rapid Test to the FDA, including inaccurate test results or injuries from self-swabbed nasopharyngeal or oropharyngeal be promptly reported (using this link)<\/a>.<\/p>\n

FDA Explains COVID-19 Testing Basics<\/h3>\n
\"FDA\"
Courtesy of Jernej Furman (Flickr CC0)<\/figcaption><\/figure>\n

Diagnostic tests and antibody tests have different purposes. The first is basic; diagnostic tests detect an active COVID-19 infection present. There are two types of diagnostic tests, molecular, which detect genetic material, and antigen, which looks for specific proteins. Samples for these are typically collected with a nasal or throat swab or with saliva spit into a tube, according to the FDA.<\/p>\n

The second type looks for antibodies in a person’s immune system produced in response to SARS-CoV-2, the virus that causes COVID-19. An antibody test should be used to detect active infection since antibodies can take days or weeks to develop after an infection starts. Moreover, it may remain in the person’s blood for several weeks after the symptoms are gone. Usually, these tests use a blood sample, either from a finger stick or blood is drawn a physician or other medical personnel.<\/p>\n

Once a person is tested, the FDA states they need to quarantine and sequester themselves at home until they have their test results and follow a health care provider or public health expert’s advice.<\/p>\n

There are numerous types of COVID-19 tests the FDA recommends for a person to collect their specimen:<\/p>\n