Since the start of 2022, the U.S. Food and Drug Administration has issued several warnings about COVID-19 tests, including one Tuesday regarding the SD Biosensor Inc. STANDARD Q Ag Home Test.
According to the FDA, this test is “not authorized, cleared, or approved by the FDA for distribution or use,” in the U.S. and it could produce false results.
These nasal swab sample tests are used to detect proteins called antigens from SARS-CoV-2, the virus that causes COVID-19. They packaged in white and magenta boxes.
While the FDA does not recommend using the SD Biosensor Inc.
STANDARD Q Ag Home Test, it has not received any reports of injuries, adverse health consequences, or death associated with use of the product.
However, it said “a false-negative result may lead to delayed diagnosis or inappropriate treatment…which may cause people harm including serious illness and death,” or further spread of COVID-19. On the other hand, false positive results could lead to patients receiving delayed or inappropriate care for their actual illness.
Those who have already used the test should consult their health care providers with concerns about results.
Any health care providers and testing program organizers who have used this test in the past two weeks should consider retesting patients using an FDA authorized or cleared SARS-CoV-2 diagnostic test.
“If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest,” said the FDA.
People should also report any problems with the SD Biosensor Inc. STANDARD Q Ag Home Test to the FDA, including suspected false results. SD Biosensor, Inc. has initiated a recall for all unauthorized SD Biosensor STANDARD Q COVID-19 Ag Home Tests that were distributed in the U.S.
While the FDA does not recommend use of SD Biosensor Inc.
STANDARD Q Ag Home Test, a different test called the SD Biosensor COVID-19 At-Home Test distributed by Roche was approved by the administration in January and is recommended for use.
In addition to the SD Biosensor STANDARD Q COVID-19 Ag Home Tests, the FDA issued two more safety communications Tuesday regarding COVID-19 tests. One warned against using a test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” that is packaged in a dark blue box and another warned against using the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging.
Both tests may lead to false results, there are no reports of injuries or adverse health effects related to them.
Other tests identified for possible false result issues in safety communications by the FDA this year include: the E25Bio COVID-19 Direct Antigen Rapid Test, Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test, ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.
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