Summary And Explanation Of The Test
Coronaviruses are a large family of viruses that can cause disease in animals or humans. SARS-CoV-2 is an enveloped single-stranded RNA virus of the genus β. The virus can cause mild to severe respiratory disease and has spread throughout the world, including the United States. BinaxNOWTM COVID-19 Ag Card is a rapid lateral flow immunoassay for qualitative detection and diagnosis of SARS-CoV-2 directly from nasal swabs, without viral transport media. The BinaxNOWTM COVID-19 Ag Card Kit contains all the necessary components to perform a SARS-CoV-2.
- Rapid identification of potentially contagious individuals
- Test results in 15 minutes
- Large-scale deployment at the point of care
- It can be used in a wide variety of non-laboratory environments.
- No special/additional instruments required
- A self-contained tube with a “breakable” swab minimizes personnel exposure
- The extraction tube is completely closed for disposal.
Principles Of The Procedure
BinaxNOWTM COVID-19 Ag Card is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect the SARS-CoV-2 nucleocapsid protein from nasal swab specimens SARS-CoV-2 specific antibodies and a control antibody are immobilized on membrane support as two distinct lines and combined with other reagents/pads to build a test strip. This test strip and a well to contain the swab sample are mounted on opposite sides of a hinged cardboard test card in the form of a book.
To perform the test, a nasal swab sample is taken from the patient, 6 extraction drops of Reagent from a dropper bottle is 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 pushed up firmly until the tip of the swab is visible through the upper hole.
The swab is rotated 3 times clockwise and the card is closed, putting the extracted sample in contact with the test strip. The test results are visually interpreted at 15 minutes based on the presence or absence of visually detectable pink/purple lines. Results should not be read after 30 minutes.
Reagents And Materials
- Test Cards (40): a hinged book-shaped cardboard test card containing the test strip
- Extraction reagent (1): a bottle containing 7.5 ml of extraction reagent
- Nasal Swabs (40) – Sterile swabs for use with the BinaxNOWTM COVID-19 Ag Card Test
- Positive control swab (1): non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried on a swab
- Negative Control Swab – Use of a sterile patient swab ensures appropriate negative results are obtained
Materials required but not provided
Clock, timer or stopwatch
Materials available as an optional accessory
Swab Transport Tube Accessory Pack
1. For in vitro diagnostic use.
2. This product has not been cleared or approved by the FDA; but it has been cleared by the FDA under a EUA for use by laboratories certified under the Clinical Laboratory Improvement 1988 Amendments (CLIA), 42 U.S.C. §263a, to perform moderate, high, or waived complexity tests and in the Point of Care (POC), that is, inpatient care settings that operate under a CLIA Certificate of Exemption, Certificate of Compliance or Certificate of Accreditation
3. Federal law restricts the sale of this device to or by order of a licensed professional (US) only).
4. This product has only been authorized for the detection of SARS-CoV-2 proteins, not for any other virus or pathogen
5. This product is only authorized for the duration of the declaration that the circumstances exist that justify the authorization of the emergency use of in vitro diagnostics for the detection and / or diagnosis of COVID-19 under Section 564
6. Laboratories within the United States and its territories are required to report all results to the corresponding public health laboratories.
7. Treat all samples as potentially infectious. Follow universal precautions when handling samples, this kit and its contents.
8. Proper specimen collection, storage, and transportation are essential to obtain correct results.
9. Leave the sealed test card in its foil pouch until just before use. Do not use it if the bag is damaged or open.
10. Do not use the kit after its expiration date.
11. Do not mix components from different kit lots.
12. Do not reuse the used test card.
13. Improper or inappropriate collection, storage, and transportation of specimens may lead to false testing results
14. Do not store or test specimens in viral transport media as this may result in false-positive or false-negative results.
15. All components of this kit must be disposed of as biohazard waste in accordance with federal laws, State and local regulatory requirements.