Description

Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. For self-testing use. For use under an Emergency Use Authorization (EUA) only.

Disclosure:

This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Product Insert Information |FDA Emergency Use Authorization Letter

Accuracy Summary:

Positive Percent Agreement: 93.0%

Negative Percent Agreement: 100%

What is included with this kit?

This COVID-19 rapid antigen nasal test kit is sold in a single box and includes the following:

• (1) Rapid Testing Cassettes
  • Foil pouched test device containing one test strip which
    is encased in plastic device cassette.
• (1) Extraction Vials/Caps
  • The extraction vial contains 400 μl extraction buffer
    solution.
• (1) Disposable Nasal Swab
  • Swabs for shallow nasal specimen collection
• (1) Instruction For Use Insert

Intended Use of Rapid COVID-19 Antigen Nasal Test Kit

• This COVID-19 Antigen test is a lateral flow immunochromatographic assay
  intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
  nasopharyngeal swab specimens directly collected, or collected in BD universal transport media,
  from individuals suspected of COVID-19 by their healthcare provider within five days of symptom
  onset.
• This test is authorized for Over The Counter Use (OTC)
• Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen
  is generally detectable in anterior nasal swab specimens during the acute phase of infection.
• Positive results indicate the presence of viral antigens, but the clinical correlation with patient
  history and other diagnostic information is necessary to determine infection status. Positive
  results do not rule out a bacterial infection or co-infection with other viruses. The agent detected
  may not be the definite cause of disease. Laboratories within the United States and its territories
  are required to report all results to the appropriate public health authorities.
• Negative results are presumptive and confirmation with a molecular assay, if necessary, for
  patient management may be performed. Negative results do not rule out SARS-CoV-2 infection
  and should not be used as the sole basis for treatment or patient management decisions,
  including infection control decisions. Negative results should be considered in the context of a
  patient’s recent exposures, history and the presence of clinical signs and symptoms consistent
  with COVID-19.