BinaxNOW
™
ANTIGEN SELF TEST
COVID-19
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 Antigen Self Test is a rapid lateral flow immunoassay for the
qualitative detection of SARS-CoV-2 directly from anterior nasal swabs, without viral transport
media. The BinaxNOW COVID-19 Antigen Self Test kit contains all components required to carry
out an assay for SARS-CoV-2.
PRINCIPLES of the PROCEDURE
The BinaxNOW COVID-19 Antigen Self Test is an immunochromatographic membrane assay
that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from direct
anterior 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, an anterior nasal swab specimen is collected by 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
Test Cards (2): A cardboard, book-shaped hinged test card containing the test strip
Extraction Reagent (2): Bottle containing <1 mL of extraction reagent
Nasal Swabs (2): Sterile swab for use with BinaxNOW COVID-19 Antigen Self Test
Patient Instructions for Use (1)
Individual Fact Sheet (1)
PRECAUTIONS
1. 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. Wear safety mask or other face covering when collecting anterior nares swab specimen from a
child or another individual.
4. Use of gloves is recommended when conducting testing.
5. Keep testing kit and kit components out of the reach of children and pets before and after use.
6. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for
any other viruses or pathogens.
7. The emergency use of 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.
8. Proper sample collection and handling are essential for correct results.
9. Do not use a kit that has been opened and/or tampered with.
10. Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or
open.
11. Do not dip the swab into the liquid reagent or other liquid before inserting the swab into the nose.
12. Do not touch swab tip when handling the swab sample.
13. Do not use kit past its expiration date.
14. Do not mix components from dierent kit lots.
15. All kit components are single use items. Do not use with multiple specimens. Do not reuse the
used test card or swab.
16. Dispose of kit components and patient samples in household trash.
17. INVALID RESULTS can occur when an insucient volume of extraction reagent is added to the
test card. To ensure delivery of adequate volume, hold bottle vertically, 1/2 inch above the swab
well, and add drops slowly.
18. The Reagent Solution contains a harmful chemical (see table below). If the solution contacts the
skin or eye, flush with copious amounts of water. If irritation persists, seek medical advice:
https://www.poison.org/contact-us or 1-800-222-1222.
Chemical Name/CAS GHS Code for each Ingredient Concentration
Sodium Azide/26628-22-8 Acute Tox. 2 (Oral), H300
Acute Tox. 1 (Dermal), H310
0.0125%
STORAGE and STABILITY
Store kit between 35.6-86°F (2-30°C). Ensure all test components are at room temperature
before use. The BinaxNOW COVID-19 Antigen Self Test is stable until the expiration date marked
on the outer packaging and containers.
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 Antigen Self Test is a lateral flow immunoassay intended for the
qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with
or without symptoms or other epidemiological reasons to suspect COVID-19 infection when
tested twice over three days with at least 36 hours between tests. This test is authorized for
non-prescription home use with self-collected direct anterior nasal (nares) swab samples from
individuals aged 15years or older or adult collected anterior nasal swab samples from individuals
aged two years or older.
The BinaxNOW COVID-19 Antigen Self Test does not dierentiate 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 past medical 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
Antigen Self Test should self-isolate and seek follow-up care with their physician or healthcare
provider as additional testing may be necessary.
Negative results should be treated as presumptive, 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 an individual’s recent exposures, history and the presence of clinical signs and symptoms
consistent with COVID-19 and confirmed with a molecular assay, if necessary, for patient
management. For serial testing programs, additional confirmatory testing with a molecular test
for negative results may be necessary, if there is a high likelihood of COVID-19, such as, an
individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in
communities with high prevalence of infection. Additional confirmatory testing with a molecular
test for positive results may also be necessary, if there is a low likelihood of COVID-19, such
as in individuals without known exposures to COVID-19 or residing in communities with low
prevalence of infection.
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. 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 Antigen Self 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 Antigen Self Test is only for use under the Food
and Drug Administration’s Emergency Use Authorization.
4. Open swab package at stick
end. Take swab out.
1. Wash or sanitize your hands.
Make sure they are dry before
starting.
Carefully read instructions prior to starting test.
It is recommended gloves (not provided) also be used
during testing.
Card must stay FLAT on table for entire test.!
3. Remove dropper bottle cap.
Hold dropper bottle straight
over top hole, not at an
angle.
Put 6 drops into top hole.
Do not touch card with tip.
2. Remove test card from
pouch and lay flat on table.
The card must stay flat on
the table for the entire test.
Make sure the blue control
line is present in the result
window. If a blue line is not
present, do not use this card.
Open card flat on table. You
may bend the spine in the
opposite direction to help the
card lay flat.
Keep fingers away from the swab end.!
Up to 3/4
of an inch
At least 5
big circles
At least 5
big circles
Note: False negative result may occur if the nasal swab is not
properly collected.
DIRECTIONS FOR RUNNING THE BINAXNOW COVID-19 AG CARD SELF TEST
Note: False negative result may occur if less than 6 drops of fluid are
put in the hole.
1 Dropper Bottle Timing Device
(not included)
1 Swab 1 Test Card in Pouch
B
i
nax
NOW
™
C
O
VO
O
I
D
-
19
A
g
C
A
RD
S
AMPLE
CON
TR
OL
DO NOT touch
the test strip.
DO NOT touch any parts on the inside. Handle card only by edges.!
6 drops6 drops
Check:
Did you swab BOTH nostrils?
A
A
B
B
C
C
5. Swab both nostrils carefully
as shown.
Insert the entire soft tip of the
swab into a nostril (usually 1/2
to 3/4 of an inch).
You do not need to go deeper.
Using medium pressure, rub
the swab against all of the
inside walls of your nostril.
Make at least 5 big circles.
Do not just spin the swab.
Each nostril must be swabbed
for about 15 seconds.
Using the same swab, repeat
step 5 in your other nostril.
SAMPLE
CONTROL
Result Result
windowwindow
or
PREPARE FOR THE TEST
A.
BEFORE STARTING
COLLECT NASAL SAMPLE
B.
Loading ...
Loading ...
Loading ...
