Rapid Antigen Test

COVID-19 Testing: Abbott BinaxNOW™
Rapid Antigen Test

The 15-minute BinaxNOW™ COVID-19 Ag Card Test has received FDA Emergency Use Authorization for at-home testing. This first-of-its-kind service for COVID-19 testing prescribes and ships the test directly to your home.

BinaxNOW™ COVID-19 Antigen Test: a breakthrough antigen test (CDC)

  • Simple test procedure using a nasal swab, and a test kit the size of a credit card
  • Receive results in 15 minutes
  • Detects active COVID-19 infection
  • Intended for individuals suspected of COVID-19 within the first seven days of symptom onset
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SUMMARY and EXPLANATION of the TEST

Coronaviruses are a large family of viruses that may cause illness in animals or humans. SARS-CoV-2 is an enveloped, single-stranded RNA virus of the ? genus. The virus can cause mild to severe respiratory illness and has spread globally, including in the United States. The BinaxNOW COVID-19 Ag Card Test is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 directly from nasal swabs, without viral transport media. The BinaxNOW COVID-19 Ag Card Test Kit contains all components required to carry out an assay for SARS-CoV-2.?

Frequently asked Questions

The BinaxNOW™ COVID-19 Antigen Self Test utilizes a nasopharyngeal swab and a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms.

The BinaxNOW™ COVID-19 Ag tests have been authorized by the FDA under an emergency use authorization for the detection of proteins from SARS-CoV-2.

The test is indicated for all people aged 15 years or older and for children as young as 2 years old when samples are collected by an adult. The test can be used for people with and without symptoms.

Testing will remain an essential part of our short- and long-term COVID-19 recovery strategy. Testing will be a key tool alongside vaccination as we get back to life. We don't yet know how long vaccines confer immunity and how variants will evolve

The tests should be administered twice over three days with at least 36 hours between tests

The BinaxNOW COVID-19 Ag Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens. SARS-CoV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card. To perform the test, a nasal swab specimen is collected under observation by or from the patient, then 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.

All patients will receive access to their test results through a HIPAA compliant online portal system.

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results should be treated as 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. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. BinaxNOW COVID-19 Ag Card Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).