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Mar 14, 2022 · While the Flowflex test that comes in a white box with the full name "Flowflex COVID-19 Antigen Home Test" is safe to use ... "Flowflex SARS-CoV-2 Antigen Rapid Test ...
- Jessica Rendall
- Wellness Writer
The Flowflex COVID-19 Antigen Home Test is a qualitative membrane based chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human ...
All subjects were screened for the presence or absence of COVID-19 symptoms within two weeks of study enrollment. The Flowflex COVID-19 Antigen Home Test was compared to an FDA authorized molecular SARS-CoV-2 test. The Flowflex COVID-19 Antigen Home Test correctly identified 93% of positive specimens and 100% of negative specimens.
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If you have an ACON Flowflex COVID-19 test, compare the packaging to the image above. Do not use the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in the dark blue packaging, as shown above. 1. Test users and caregivers:Talk to your health care provider if you think you were tested with the ACON Biotech Flowflex SARS-CoV-2 Anti...
The unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. Th...The ACON Laboratories Flowflex COVID-19 Antigen Home Test, authorized by the FDA on October 4, 2021, is not the subject of this Safety Communication and can continue to be used.A false-negative antigen test resultmeans that the test says the person does not have COVID-19 but they actually do have COVID-19. A false-negative result may lead to delayed diagnosis or inappropr...A false-positive antigen test result means that the test says the person has COVID-19 but they are actually do not have COVID-19. A false-positive result may lead to a delay in both the correct dia...The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is working with ACON Laboratories, Inc. to resolve this safety issue. ACON Laboratories, Inc. has initiated a recall for all unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Tes...
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOVor call 800-638-2041 or 301-796-7100.
Flowflex COVID-19 Antigen Home Test. 1. What is the Flowflex COVID-19 Antigen Home Test? The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. It is intended for self-testing use. For use under an Emergency Use Authorization (EUA) only. 2.
A positive test result for COVID-19 indicates that antigens from SARS -CoV-2 were detected, and therefore the individual being tested is infected with the virus and presumed to be contagious.
Aug 8, 2021 · Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients Shahad Saif Khandker , 1, † Nik Haszroel Hysham Nik Hashim , 2, 3, † Zakuan Zainy Deris , 2, 3 Rafidah Hanim Shueb , 2, * and Md Asiful Islam 4, *
