BinaxNOW
™
COVID19 Ag
CARD HOME TEST
Healthcare Provider Instructions for Use
For Use Under an Emergency Use Authorization (EUA) Only
For use with anterior nasal swab specimens
For in vitro Diagnostic Use Only
INTENDED USE
The BinaxNOW
™
COVID-19 Ag Card Home Test is a lateral flow immunoassay device intended for the qualitative
detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with
self-collected observed anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior
nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of
COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours
between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested
at least three times over five days with at least 48 hours between tests.
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 dierentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen which 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. Individuals who test positive with the BinaxNOW COVID-19 Ag Card Home Test should self-isolate and seek
follow up care with their physician or healthcare provider as additional testing may be necessary.
All negative results are 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 measures such as isolating from others and wearing masks.
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 of fever, cough and/or shortness of breath
may still have SARS-CoV-2 infection and should seek follow up care from their healthcare provider.
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and
to receive appropriate medical care. All healthcare providers will report all test results they receive from individuals who use
the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using
appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping
for SARS-CoV-2 Tests provided by CDC.
The BinaxNOW COVID-19 Ag Card Home Test is intended for non-prescription self-use and/or, as applicable for an adult
lay user testing another person aged 2 years or older in a non-laboratory setting. The BinaxNOW COVID-19 Ag Card
Home Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This
product has not been FDA cleared or approved.
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.
PRINCIPLES of the PROCEDURE
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.
REAGENTS and MATERIALS
Materials Provided (Your box may contain more than one test kit set)
Test Cards (1 or 2): A cardboard, book-shaped hinged test card containing the test strip
Extraction Reagent (1 or 2): Bottle containing <1 mL of extraction reagent
Nasal Swabs (1 or 2): Sterile swab for use with BinaxNOW COVID-19 Ag Card Home test
1 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use