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The BinaxNOW COVID-19 Ag Card is a proven and trusted COVID-19 nasal swab antigen test that gives an accurate visual result in 15 minutes. The BinaxNOW COVID-19 Ag Card is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens via point of care. 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.

To perform the test, a nasal swab specimen is collected from the patient, 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.

Materials Provided for Abbott BinaxNOW™ COVID-19 Ag Card:

• 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 to take your COVID test properly
• Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results are obtained
• Product Insert (1)
• Procedure Card (1)

Additional Information for Abbott BinaxNOW™ COVID-19 Ag Card:

• For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only
  Lateral flow assay
• Rapid results in 10 minutes
• Nasopharyngeal swab specimen collection
• Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Detect SARS-CoV-2 nucleocapsid protein antigen
• Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity
• Designated as a CLIA waived tests (CLIA 195-000)
  

Clinical Performance Characteristics of Abbott BinaxNOW™ COVID-19 Ag Card:

Clinical performance characteristics of BinaxNOW™ COVID-19 Ag Card were evaluated in a multisite prospective study in the U.S in which patients were sequentially enrolled and tested. A total of ten (10) investigational sites throughout the U.S. participated in the study. Testing was performed by operators with no laboratory experience and who are representative of the intended users at CLIA waived testing sites. In this study, testing was conducted by sixty-two (62) intended users. To be enrolled in the study, patients had to be presenting at the participating study centers with suspected COVID-19. Patients who presented within 7 days of symptom onset were included in the initial primary analysis. Two nasal swabs were collected from patients and tested using the BinaxNOW™ COVID-19 Ag Card at all study sites. An FDA Emergency Use Authorized real-time

Polymerase Chain Reaction (RT-PCR) assay for the detection of SARS-CoV-2 was utilized as the comparator method for this study.

At all sites, one nasal swab was tested directly in the BinaxNOW™ COVID-19 Ag Card test according to product instructions and the other swab was eluted in viral transport media (VTM).

Swabs were randomly assigned to testing with the BinaxNOW or RT-PCR testing and were tested by minimally trained operators who were blinded to the RT-PCR test result. All sites shipped the VTM sample to a central testing laboratory for RT-PCR.

External control testing, using BinaxNOW™ COVID-19 Ag Card Positive and Negative Controls, was performed prior to sample testing each day, at all study sites.

The performance of BinaxNOW™ COVID-19 Ag Card was established with 460 nasal swabs collected from individual symptomatic patients (within 7 days of onset) who were suspected of COVID-19.

BinaxNOW™ COVID-19 Ag Card Performance within 7 days of symptom onset against the Comparator Method

BinaxNOW™ COVID19 Ag Card

Comparator Method

Positive Agreement: 99/117 84.6% (95% CI: 76.8% - 90.6%)

Negative Agreement: 338/343 98.5% (95% CI: 96.6% - 99.5%)

Patient Demographics

Patient demographics (gender and age) are available for the 460 samples used in the analysis of patients with symptom onset within the previous seven (7) days. The table below shows the positive results broken down by age of the patient:

Age Comparator Method

Total # Positive Prevalence

< 5 years 0 - -

6 to 21 years 17 3 17.6%

22 to 59 years 312 79 25.3%

60 years 131 35 25.4%

Patient demographics, time elapsed since onset of symptoms for all patients enrolled, are patients with symptom onset greater than

Available under FDA Emergency Use Authorization (EUA). Only available in the US. 

10 x 6 x 5 in.

Instructions For Use

Product Specifications

FDA Emergency Use Authorization Letter