Global Point of Care
BINAXNOW™ COVID-19 Ag card
FAST, EASY AND COST-EFFECTIVE
COVID-19 TESTING
When it comes to testing for COVID-19, your patients are looking for answers — and you're looking for a fast, easy and cost-effective way to help. Abbott has designed the BinaxNOW™ COVID-19 Ag Card for decentralized testing, so you can test right at the point of care and get results for your patients quickly and easily.
The BinaxNOW COVID-19 Ag Card test has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).*
Only available in the US.
Benefits
BinaxNOW COVID-19 Ag Card
cost-effective, easy-to-use rapid antigen test
- Simple, CLIA-waived test procedure**
- Direct nasal swab
- No instrument necessary
- Visually read results in 15 minutes
- Room temperature storage
Fast, easy test procedure***
Add the
extraction reagent
Insert the sample
nasal swab
Rotate the nasal swab
shaft three times
Close the test card;
wait 15 minutes
Results are
read visually
Helpful Documents
PRODUCT DOCUMENTS
SPECIFICATIONS
- Method: Lateral Flow
- Time to Result: 15 minutes
- Sample Type: Direct nasal swab
- Performance: Direct nasal swabs taken from individuals suspected of COVID-19 by their healthcare provider within seven days of symptom onset.
- Positive Percent Agreement (PPA): 84.6%
- Negative Percent Agreement (NPA) 98.5%
PPA data has been supplemented with the results of a study conducted by the National Institutes of Health (NIH) that pooled the results of several manufacturers’ tests when patients were serially tested. The data shows that repeat COVID-19 antigen testing after a negative test result can increase the chances of detecting COVID-19 in people with and without symptoms. The supplemental data indicates that antigen tests have demonstrated PPA as high as 100% for symptomatic patients (3 serial tests, 2 days after first PCR positive) and as high as 88.9% for asymptomatic patients (3 serial tests, 6 days after first PCR positive).1
- Kit Size: 40 Tests
- Kit Contents:
- 40 Test Cards
- 40 Nasal Swabs
- Positive Control Swab
- Reagent Bottle
- Package Insert
- Procedure Card
- 40 Patient COVID-19 Fact Sheets
- Healthcare Provider COVID-19 Fact Sheet
PRODUCT CODE
| BinaxNOW™ COVID-19 Ag Card | Code |
|---|---|
| BinaxNOW™ COVID-19 Ag Card (40CT) | 195-000 |
| BinaxNOW™ COVID-19 Ag Card Control Kit (10 Positive) | 195-080 |
| BinaxNOW™ COVID-19 Reagent Accessory Pack | 195-090 |
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VIEW REFERENCES
*The BinaxNOW COVID-19 Ag Card has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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.
** Before testing patients, federal regulations require testing sites to have a CLIA certificate issued by CMS. Sites performing only waived tests must obtain a Certificate of Waiver by applying for this certification for each location performing testing.
***Refer to the product package insert for full instructions, clinical data and information on serial testing.
- FDA Letter "Revisions Related to Serial (Repeat) Testing for the EUAs of Antigen IVDs." November 1, 2022. Accessed March 3, 2023. https://www.fda.gov/media/162799/download