Main Binax Now Rapid COVID-19 Ag Card (40 Tests Per Box)
REAGENTS AND MATERIALS
- Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip
- Extraction Reagent (1): Bottle containing 7.5 mL of extraction reagent
- Nasal Swabs (40): Sterile swabs for use with BinaxNOWTM COVID-19 Ag Card test
- Positive Control Swab (1) : Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab
- Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results are obtained
- Product Insert (1)
- Procedure Card (1)
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 FDA cleared or approved; but has been authorized by FDA
under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high or waived complexity tests and 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.
3. Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).
4. This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens
5. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
6. Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories.
7. Treat all specimens as potentially infectious. Follow universal precautions when handling samples, this kit and its contents.
8. Proper sample collection, storage and transport are essential for correct results.
9. Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or open.
10. Do not use kit past its expiration date.
11. Do not mix components from different kit lots.
12. Do not reuse the used test card.
13. Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
14. Do not store or test specimens in viral transport media, as it may result in false positive or false negative results.
15. All components of this kit should be discarded as Biohazard waste according to Federal, State and local regulatory requirements.
16. Solutions used to make the positive control swab are non-infectious. However, patient samples, controls, and test cards should be handled as though they could transmit disease. Observe established precautions against microbial hazards during use and disposal.
17. Wear appropriate personal protection equipment and gloves when running each test and handling patient specimens. Change gloves between handling of specimens suspected of COVID-19.
18. INVALID RESULTS can occur when an insufficient volume of extraction reagent is added to the test card. To ensure delivery of adequate volume, hold vial vertically, ½ inch above the swab well, and add drops slowly.
19. False Negative results can occur if the sample swab is not rotated (twirled) prior to closing the card.
20. Swabs in the kit are approved for use with BinaxNOWTM COVID-19 Ag Card. Do not use other swabs.
21. The Extraction Reagent packaged in this kit contains saline, detergents and preservatives that will inactivate cells and virus particles. Samples eluted in this solution are not suitable for culture.
22. Do not store the swab after specimen collection in the original paper packaging, if storage is needed use a plastic tube with cap.