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BinaxNOW COVID-19 Ag Card Home Test, NAVICA app, and eMed digital health solution
$45.00 per test
The 15-minute BinaxNOW™ COVID-19 Ag Card Home Test is a complete at-home solution to rapid COVID-19 testing. This BinaxNOW COVID test is the first FDA/EUA-authorized, virtually guided, COVID-19 rapid test with automated results reporting. Live testing support from eMed Certified Guides ensures improved sample collection and confidence in results. This product is good to use for international re-entry into the United States.
The 15-minute BinaxNOW™ COVID-19 Ag Card Home Test has received FDA Emergency Use Authorization for at-home testing in collaboration with eMed, a digital health solution. This first-of-its kind service for COVID-19 testing prescribes and ships the test directly to your home. A trained telehealth professional then guides you through the at-home self-test via video call using the BinaxNOW COVID-19 Ag Card Home Test and Abbott’s complementary NAVICA™ mobile app to enable the testing process and display BinaxNOW COVID-19 test results. Note: the CVS product does not come with the NAVICA™ app or eMed™ digital health solution. This product is good to use for international re-entry into the United States.
BINAXNOW COVID-19 Ag Card Home 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
NAVICA Mobile App: designed to restore confidence in daily life
- Display your COVID-19 test result and review previously stored COVID-19 test results
- Receive an encrypted, digital NAVICA Pass with a negative test result, similar to an airline boarding pass
- Share your NAVICA Pass with NAVICA-enabled organizations such as employers and schools to verify your negative COVID-19 test results
eMed Digital Health Solution: your guide to at-home testing
- Provides a digital platform for fast, easy and affordable at-home COVID-19 testing
- Includes certified guides to direct and supervised testing via video call.
SUMMARY and EXPLANATION of the TEST
Coronaviruses are a large family of viruses which may cause illness in animals or humans. SARS-CoV-2 is an enveloped, single-stranded RNA virus of the β genus. The virus can cause mild to severe respiratory illness and has spread globally, including the United States. The BinaxNOW COVID-19 Ag Card Home 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 Home Test kit contains all components required to carry out an assay for SARS-CoV-2.
Similar to some of our other COVID-19 tests, The BinaxNOW™ COVID-19 Ag Card Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset or adult collected nasal swab samples from individuals aged four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The BinaxNOW COVID-19 Ag Card Home Test is to be performed only with the supervision of a telehealth proctor. The BinaxNOW COVID-19 Ag Card Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection.
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.
So how does it work?
The BinaxNOW COVID-19 Ag Card Home 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.
The BinaxNOW™ COVID-19 Ag Card Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. The test 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 diagnostic tests 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.
Feel free to contact us any time with questions at firstname.lastname@example.org, and we’d be happy to help you out!
- DO NOT OPEN THE BOX UNTIL INSTRUCTED TO DO SO! Failing to follow this instruction could invalidate your test results.
- Here is a how-to video describing how to use the test, from Abbott.
- Here is a technical document describing how to use the test from the EUA submission.
- Here are some simplified Meenta instructions for using this product.
- The CDC also had some very useful instructions for nasal swab collections here.
- Test Cards (1): A cardboard, book-shaped hinged test card containing the test strip
- Extraction Reagent (1): Bottle containing <1 mL of extraction reagent
- Nasal Swabs (1): Sterile swab for use with BinaxNOW COVID-19 Ag Card Home test Materials
Required but not Provided
- Clock, timer or stopwatch Smart
- Phone:* Apple is IOS 11 or newer Android is version 8 or newer *Required to download the NAVICA app from the Google play store or Apple app store
1. This BinaxNOW COVID test is for in vitro diagnostic use.
2. This test has not been FDA cleared or approved but has been authorized by FDA under an EUA.
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. Proper sample collection and handling are essential for correct results.
7. Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or open.
8. Do not touch swab tip when handling the swab sample.
9. Do not use kit past its expiration date.
10. Do not mix components from different kit lots.
11. All kit components are single use items. Do not use with multiple specimens. Do not reuse the used test card.
12. Wash hands thoroughly or use hand sanitizer after handling. It is recommended gloves (not provided) also be used during testing.
13. Dispose of kit components and patient samples in household trash.
14. 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, 1/2 inch above the swab well, and add drops slowly.
Want to learn more about picking the perfect COVID-19 test for your situation? Check out our blog on this topic here.
- Credit Card
- HSA Card
- PO Number
Note: These products and services are not returnable.