BinaxNOW
™
ANTIGEN SELF TEST
COVID19
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.
BinaxNOW COVID-19 Antigen Self Test instructions for use are provided as a paper copy within the
testkit and available digitally via website link (www.binaxnow-selftest.abbott).
REAGENTS and MATERIALS
Materials Provided
Test Cards (1, 2, 4, 5 or 10): A cardboard, book-shaped hinged test card containing the test strip
Extraction Reagent (1, 2, 4, 5 or 10): Bottle containing <1 mL of extraction reagent
Nasal Swabs (1, 2, 4, 5 or 10): Sterile swab for use with BinaxNOW COVID-19 Antigen Self Test
Patient Instructions for Use (1)
WARNINGS, PRECAUTIONS and SAFETY INFORMATION
1. Read all instructions carefully before performing the test. Failure to follow the instructions may result
in inaccurate test results.
2. For in vitro diagnostic use.
3. In the USA, this product has not been FDA cleared or approved but has been authorized by FDA
under an Emergency Use Authorization. This product has been authorized only for the detection
of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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.
4. Wear safety mask or other face covering when collecting anterior nares swab specimen from a child or
another individual.
5. Use of gloves is recommended when conducting testing.
6. Keep testing kit and kit components out of the reach of children and pets before and after use.
7. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other
viruses or pathogens.
8. Incorrect test results may occur if a specimen is incorrectly collected or handled.
9. Do not use if any of the test kit components or packaging is damaged.
10. Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or open. Once
opened, the test card should be used immediately.
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 dierent 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 insucient 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.
19. Serial testing should be performed in individuals with negative results at least twice over three days
(with 48 hours between tests) for symptomatic individuals and three times over five days (with at
least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional
tests to perform this serial (repeat) testing.
20. An anterior nasal swab sample can be self-collected by an individual age 15 years and older. Children
age 2 to 15 years should be tested by an adult.
21. If you have had symptoms longer than 7 days you should consider testing at least three times over
five days with at least 48 hours between tests.
22. Do not use on anyone under 2 years of age.
23. Do not read test results before 15 minutes or after 30 minutes. Results read before 15 minutes or
after 30 minutes may lead to false positive, false negative, or invalid result.
24. There is a higher chance of false negative results with antigen tests than with laboratory-based
molecular tests. This means that there is a higher chance this test will give you a negative result when
you have COVID-19.
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%
For more information on EUAs please visit: https://www.fda.gov/emergencypreparedness-and-response/
mcm-legal-regulatory-and-policy-framework/emergencyuse-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
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. For information about current expiration dates for at-home OTC COVID-19
diagnostic tests, visit http://www.fda.gov/covid-tests.
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.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab
samples from individuals aged 15years or older or adult collected anterior nasal (nares) swab samples
from individuals 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 Antigen Self Test does not dierentiate 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 Antigen Self Test should self-
isolate and seek follow-up care with their physician or healthcare provider as additional testing may be
necessary.
All 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 measures such as isolating from others and wearing masks. 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.
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 report their test result obtained with this product to their healthcare provider in
order 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 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. 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 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
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.
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
1 Dropper Bottle Timing Device
(not included)
1 Swab
Your box may contain more than one test kit.
Use only 1 of each of the following for each test:
1 Test Card in Pouch
B
i
nax
NOW
™
C
O
V
O
O
D
-
19
A
g
C
A
RD
S
AMPLE
CON
TR
OL
DO NOT touch any parts on the inside. Handle card only by edges.!
Check:
Did you swab BOTH nostrils?
a
b
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.
or
PREPARE FOR THE TEST
A.
BEFORE STARTING
COLLECT NASAL SAMPLE
B.
1
2
3
Result Window
Top Hole
Lower HoleTest Strip
Top
Bottom
Outside of Card Inside of Card
2.
Remove test card from pouch.
Make sure the blue control
line is present in the result
window. Do not use the card if
it is not.
SAMPLE
CONTROL
Open the card and lay it flat
on the table with the pink side
down. You may bend the spine
in the opposite direction to
help the card lay flat.
DO NOT touch the test strip.
!
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.
6 drops6 drops
Note: False negative result may occur if more than 6 drops of fluid are
put in the hole.
Visit www.globalpointofcare.abbott/us/en/support/
binaxnow-covid-19-antigen-self-test-us.html
toreport your results and view instructions for use.
B. Check for Negative COVID-19 Result
Find result window and look carefully for two pink/purple lines.
Positive Result: If you see two pink/purple lines (one on the top half and
one on the bottom half), this means COVID-19 was detected.
Below are photos of actual positive tests. On the right, note how faint the
bottom line can get.
Repeat testing does not need to be performed if patients have a positive
result at any time.
Look very closely!
The bottom line
can be very faint.
Any pink/purple
line visible here is a
Positive Result.
Find result window and look for a single pink/purple line in window.
Negative Result: If you see only one pink/purple line on the top half,
where it says “Control
„
this means COVID-19 was not detected.
To increase the chance that the negative result for COVID-19 is accurate,
you should:
• Test again in 48 hours if you have symptoms on the first day of
testing.
• Test 2 more times at least 48 hours apart if you do not have
symptoms on the first day of testing.
Repeat testing is needed to improve test accuracy. Please follow the table
below when interpreting test results.
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.
CONTROL
SAMPLE
No Line
Negative
No Line
Negative
PERFORM THE TEST
C.
INTERPRET RESULTS
D.
A. Check for Positive COVID-19 Result
CONTROL
SAMPLE
PositivePositive
Solid Line Faint Line
OR
Solid Line
Positive
Faint Line
Positive
RESULT INTERPRETATION
Positive Result
A positive test result means that the virus that causes COVID-19 was detected in the sample and
it is very likely the individual has COVID-19 and is contagious. Please contact the doctor/primary
care physician (if applicable) and the local health authority immediately and instruct your patient to
adhere to the local guidelines regarding self-isolation. There is a very small chance that this test can
give a positive result that is incorrect (a false positive result).
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 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.
Negative Result
A negative test result indicates that the virus that causes COVID-19 was not detected in the sample.
A negative result does not rule out COVID-19. There is a higher chance of false negative results with
antigen tests compared to laboratory-based tests such as PCR. If the test is negative but COVID-19-like
symptoms, e.g., fever, cough, and/or shortness of breath continue, follow up testing for SARS-CoV-2
with a molecular test or testing for other respiratory disease should be considered. If applicable, seek
follow up care with the primary health care provider.
All negative results should be treated as presumptive and confirmation with a molecular assay may be
necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close
contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high
prevalence of infection. 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.
LIMITATIONS
• This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test performance
depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture
results performed on the same sample.
• A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
• The performance of the BinaxNOW COVID-19 Antigen Self Test was evaluated using the procedures
provided in this product insert only. Modifications to these procedures may alter the performance of
the test.
• Incorrect test results may occur if a specimen is improperly collected or handled.
• False negative results may occur if inadequate extraction buer is used (e.g., <6 drops).
• False negative results may occur if specimen swabs are not twirled within the test card.
• False negative results may occur if swabs are stored in their paper sheath after specimen collection.
• Positive test results do not rule out co-infections with other pathogens.
• Positive test results do not dierentiate between SARS-CoV and SARS-CoV-2.
• Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
• The presence of mupirocin may interfere with the BinaxNOW COVID-19 Antigen Self Test and may
cause false negative results.
• All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay
may be necessary.
• There is a higher chance of false negative results with antigen tests than with laboratory-based
molecular tests due to the sensitivity of the test technology. This means that there is a higher chance
this test will give a false negative result in an individual with COVID-19 compared to a molecular test,
especially in samples with low viral load.
• If the dierentiation of specific SARS viruses and strains is needed, additional testing, in consultation
with state or local public health departments, is required.
• The performance of this test was established based on the evaluation of a limited number of clinical
specimens collected in January, 2021 and May, 2022. The clinical performance has not been
established for all circulating variants but is anticipated to be reflective of the prevalent variants in
circulation at the time and location of the clinical evaluation. Performance at the time of testing may
vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their
prevalence, which change over time.
• If the patient continues to have symptoms of COVID-19, and both the patient’s first and second tests
are negative, the patient may not have COVID-19, however additional follow-up may be needed.
• If the test is positive, then proteins from the virus that causes COVID-19 have been found in the
sample and the individual likely has COVID-19.
• This test is read visually and has not been validated for use by those with impaired vision or color-
impaired vision.
PERFORMANCE CHARACTERISTICS
Clinical Performance
A prospective clinical study was conducted between January 2021 and May 2022 as a component of the
Rapid Acceleration of Diagnostics (RADx) initiative from the National Institutes of Health (NIH). A
total of 7,361 individuals were enrolled via a decentralized clinical study design, with a broad geographical
representation of the United States. Per inclusion criteria, all individuals were asymptomatic upon
enrollment in the study and at least 14 days prior to it and did not have a SARS-CoV-2 infection in the
three months prior to enrollment. Participants were assigned to one of three EUA authorized SARS-
CoV-2 OTC rapid antigen tests to conduct serial testing (every 48 hours) for 15 days. If an antigen test
was positive, the serial-antigen testing result is considered positive.
At each rapid antigen testing time point, study subjects also collected a nasal swab for comparator testing
using a home collection kit (using a 15-minute normalization window between swabs). SARS-CoV-2
infection status was determined by a composite comparator method on the day of the first antigen test,
using at least two highly sensitive EUA RT-PCRs. If results of the first two molecular test were discordant
a third highly sensitive EUA RT-PCR test was performed, and the final test result was based upon the
majority rule.
Study participants reported symptom status throughout the study using the MyDataHelps app. Two-day
serial antigen testing is defined as performing two antigen tests 36 – 48 hours apart. Three-day serial
antigen testing is defined as performing three antigen tests over five days with at least 48 hours between
each test.
Out of the 7,361 participants enrolled in the study, 5,609 were eligible for analysis. Among eligible
participants, 154 tested positive for SARS-CoV-2 infection based on RTPCR, of which 97 (62%) were
asymptomatic on the first day of their infection, whereas 57 (39%) reported symptoms on the first
day of infection. Pre-symptomatic subjects were included in the positive percent agreement (PPA) of
asymptomatic individuals, if they were asymptomatic on the first day of antigen testing, regardless of
whether they developed symptoms at any time after the first day of testing.
Performance of the antigen test with serial testing in individuals is described in the table below.
Data establishing PPA of COVID-19 antigen serial testing compared to the molecular comparator
single day testing throughout the course of infection with serial testing. Data is from all antigen tests in
study combined.
Days After
First Pcr
Positive Test
Result
Asymptomatic
On First Day Of Testing
Symptomatic
On First Day Of Testing
Ag Positive / PCR Positive
(Antigen Test Performance % PPA)
1 Test 2 Tests 3 Tests 1 Test 2 Tests 3 Tests
0
9/97
(9.3%)
35/89
(39.3%)
44/78
(56.4%)
34/57
(59.6%)
47/51
(92.2%)
44/47
(93.6%)
2
17/34
(50.0%)
23/34
(67.6%)
25/32
(78.1%)
58/62
(93.5%)
59/60
(98.3%)
43/43
(100%)
4
16/21
(76.2%)
15/20
(75.0%)
13/15
(86.7%)
55/58
(94.8%)
53/54
(98.1%)
39/40
(97.5%)
6
20/28
(71.4%)
21/27
(77.8%)
16/18
(88.9%)
27/34
(79.4%)
26/33
(78.8%)
22/27
(81.5%)
8
13/23
(56.5%)
13/22
(59.1%)
4/11
(36.4%)
12/17
(70.6%)
12/17
(70.6%)
7/11
(63.6%)
10
5/9
(55.6%)
5/8
(62.5%)
4/9
(44.4%)
3/7
(42.9%)
1 Test = one (1) test performed on the noted days after the first PCR positive test result. Day 0 is the first
day of documented infection with SARS-CoV-2.
2 Tests = two (2) tests performed an average of 48 hours apart. The first test performed on the indicated
day and the second test performed 48 hours later.
3 Tests = three (3) tests performed an average of 48 hours apart. The first test performed on the indicated
day, the second test performed 48 hours later, and a final test performed 48 hours after the second test.
Clinical performance characteristics of BinaxNOW COVID-19 Antigen Self Test was evaluated in
an ongoing multi-site prospective study in the U.S. A total of four (4) investigational sites throughout
the U.S. participated in the study. To be enrolled in the study, patients had to be presenting at the
If you see any of these, the test is invalid. An invalid result means this test
was unable to determine whether you have COVID-19 or not. A new test
is needed to get a valid result. Re-test with a new swab and new test device.
Please contact Technical Support at + 1 833-637-1594
C. Check for Invalid Result
No lines seen
Blue control
line only
Pink/purple
sample line only
Blue control line AND
pink/purple sample line
No lines seen
Blue control
line only
Pink/purple
sample line only
Blue control line AND
pink/purple sample line
No lines seen
Blue control
line only
Pink/purple
sample line only
Blue control line AND
pink/purple sample line
CONTROL
SAMPLE
No lines seen
Blue control
line only
Pink/purple
sample line
only
Blue control line
AND pink/purple
sample line
No lines seen
Blue control
line only
Pink/purple
sample line only
Blue control line AND
pink/purple sample line
Note: See other side to read about what your results mean.
Throw away all used
test kit components in the
trash.
DISPOSE THE TEST KIT
E.
BinaxNOW
™
COVID-19 Ag
CARD
SAMPLE
CONTROL
!
Keep card FLAT on table.
6. Insert swab tip into
lower hole.
Firmly push the swab tip from
the bottom hole until
it is visible in the top hole.
Do not remove the swab from
the card.
7. Turn swab to right 3 times
to mix the swab with
the drops.
Do not skip this step.
Leave the swab in the card for
the remainder of the test.
Note: False negative result can occur if swab is not turned.
!
DO NOT remove swab.
8. Peel adhesive liner o. Be
careful not to touch other
parts of card.
a
Peel
Close left side of card
over swab. Press firmly on the
two lines on right edge
of the card to seal.
b
Seal
Keep card face up on table.
!
DO NOT move or touch the card during this time.
9. Wait 15 minutes.
Read the result at 15 minutes.
Do not read the result
before 15 minutes or after 30
minutes.
WAIT
15 MINUTES
READ
AT 15-30 MINUTES
15
min
Note: A control line may appear in the result window in a few minutes
but a sample line may take as long as 15 minutes to appear.
Note: Results should not be read after 30 minutes.
3x
Status on
First Day of
Testing
First Result
Day 1
Second Result
Day 3
Third Result
Day 5
Interpretation
With
Symptoms
Positive N/A N/A
Positive for
COVID-19
Negative Positive N/A
Positive for
COVID-19
Negative Negative N/A
Negative for
COVID-19
Without
Symptoms
Positive N/A N/A
Positive for
COVID-19
Negative Positive N/A
Positive for
COVID-19
Negative Negative Positive
Positive for
COVID-19
Negative Negative Negative
Negative for
COVID-19
REPORT YOUR RESULTS
F.
Visit www.globalpointofcare.abbott/us/en/support/
binaxnow-covid-19-antigen-self-test-us.html
toreport your results.
participating study centers with suspected COVID-19 within 7 days of symptom onset. Each Subject was
provided a BinaxNOW COVID-19 Antigen Self Test. Under the observation and coaching of a clinical
site sta member trained as a proctor, the Subject self-collected one (1) nasal swab and performed the
BinaxNOW COVID-19 Antigen Self Test. Test results were interpreted and recorded by the Subject or
other home user and independently by the proctor. Parents of pediatric Subjects under the age of 14 or
Legally Authorized Representatives of adult Subjects unable to perform self-collection collected one (1)
nasal swab from the Subject, performed the BinaxNOW COVID-19 Antigen Self Test, then interpreted
and recorded the result for the patient.
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.
The performance of BinaxNOW COVID-19 Antigen Self Test was established with 53 nasal swabs
collected from individual symptomatic patients (within 7 days of onset) who were suspected of COVID-19.
BinaxNOW
™
COVID-19 Antigen Self Test Performance within 7 days of symptom onset against the
Comparator Method
BinaxNOW
™
COVID-19 Ag 2 Card
Home Test
Comparator Method
Positive Negative Total
Positive 22 0 22
Negative 2 28 30
Total 24 28 52*
Positive Agreement: 22/24 91.7% (95% CI: 73.0% - 98.9%)
Negative Agreement: 28/28 100.0% (95% CI: 87.7% - 100.0%)
*1 sample generated an invalid BinaxNOW COVID-19 Ag 2 Card result (0.1% invalid rate)
The performance of this test has not yet been clinically validated for use in patients without signs and
symptoms of respiratory infection or for serial screening applications, and performance may dier in these
populations.
Performance of BinaxNOW COVID-19 Antigen Self Test, with the test performed and results
interpreted by the home user is similar to performance obtained by test operators with no laboratory
experience. Due to the relatively small sample size for the home use clinical study, at the time of the
interim analysis, the BinaxNOW COVID-19 Antigen Self Test positive agreement established in this
ongoing clinical study is estimated to be between 73.0% and 98.9% as reflected in the 95% Confidence
Interval. This is consistent with the performance established in a separate multi-site study in the US,
where the BinaxNOW COVID-19 Ag Card test was performed and results interpreted by test operators
with no laboratory experience. In that study, BinaxNOW COVID-19 Ag Card test positive agreement
was 84.6% (95% CI: 76.8% - 90.6%), refer below:
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 COVID-19 AgCard
Comparator Method
Positive Negative Total
Positive 99 5 104
Negative 18 338 356
Total 117 343 460
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, time elapsed since onset of symptoms for all patients enrolled in the above study,
are presented in the table below. Positive results broken down by days since symptom onset:
Days Since
Symptom
Onset
Cumulative RT-
PCR Positive
(+)
Cumulative
BinaxNOW
COVID-19
Antigen Self Test
Positive (+)
PPA
95 % Confidence
Interval
1 12 10 83.3% 51.6% 97.9%
2 34 28 82.4% 65.5% 93.2%
3 50 41 82.0% 68.6% 91.4%
4 63 50 79.4% 67.3% 88.5%
5 78 63 80.8% 70.3% 88.8%
6 90 75 83.3% 74.0% 90.4%
7 117 99 84.6% 76.8% 90.6%
8 to 10 144 118 81.9% 74.7% 87.9%
11 to 14 161 126 78.3% 71.1% 84.4%
All specimens 167 129 77.2% 70.1% 83.4%
A cohort of patients who presented with symptom onset greater than seven days were enrolled in the clinical
study (n = 161). The positive agreement in patients with symptoms greater than seven days was 60% (30/50)
and negative agreement was 98% (109/111). Therefore, negative results in patients with symptom onset greater
than seven days should be interpreted with caution, as the sensitivity of the assay decreases over time.
ANALYTICAL PERFORMANCE
Limit of Detection (Analytical Sensitivity)
BinaxNOW COVID-19 Antigen Self Test limit of detection (LOD) was determined by evaluating
dierent concentrations of heat inactivated SARS-CoV-2 virus. Presumed negative natural nasal swab
specimens were eluted in PBS. Swab eluates were combined and mixed thoroughly to create a clinical
matrix pool to be used as the diluent. Inactivated SARS-CoV-2 virus was diluted in this natural nasal swab
matrix pool to generate virus dilutions for testing.
Contrived nasal swab samples were prepared by absorbing 20 microliters of each virus dilution
(1,125TCID
50
/mL) onto the swab. The contrived swab samples were tested according to the test
procedure.
The LOD was determined as the lowest virus concentration that was detected ≥ 95% of the time (i.e.,
concentration at which at least 19 out of 20 replicates tested positive).
The BinaxNOW COVID-19 Antigen Self Test LOD in natural nasal swab matrix was confirmed
140.6TCID
50
/mL in the test. Based upon the testing procedure for this study the LOD of
140.6TCID
50
/mL in the test equates to 22.5 TCID
50
/swab.
Limit of Detection (LoD) Study Results
Concentration
TCID
50
/mL
Number
Positive/Total
% Detected
140.6 20/20 100%
Omicron Testing
The performance of this test device in the detection of the Omicron variant of SARS-CoV-2 was evaluated in
a dilution series of clinical specimens which were positive for the Omicron variant. This testing was conducted
by the National Institutes of Health (NIH) as a component of the Rapid Acceleration of Diagnostics
(RADx
®
) initiative. Specimen pools were prepared by the RADx team using pooled clinical samples from
currently circulating Omicron strains and tested by RADx
®
to assess performance with the Omicron variant.
Results from this dilution series cannot be compared to any devices tested with a dierent specimen pool
and do not indicate that a test will have dierent clinical performance compared to other EUA authorized
tests. Compared to an EUA authorized RT-PCR method, the Binax NOW COVID-19 Ag Card detected
100% of live virus Omicron samples at a Ct-value of 28.7 (n=5). Testing was also compared to additional EUA
authorized OTC antigen tests (Assay #1 and Assay #2). Omicron dilutions at lower viral concentrations (Ct-
values greater than 28.7) were not detected by the Binax NOW COVID-19 Ag Card in this study.
Omicron Pool 1 – Live
Omicron Clinical
Samples
Average N2
Ct (n=9)
Assay #1
Percent
Positive
(n=5)
Assay #2
Percent
Positive
(n=5)
Binax NOW
COVID-19 Ag Card
Percent Positive
(n=5)
Dilution 1 19.9 100 100 100
Dilution 2 21.0 100 100 100
Dilution 3 22.3 100 100 100
Dilution 4 23.4 100 100 100
Dilution 5 25.0 100 100 100
Dilution 6 26.6 100 100 100
Dilution 7 27.3 0 100 100
Dilution 8 28.7 0 0 100
Dilution 9 30.1 0 0 0
Dilution 10 31.0 0 0 0
Dilution 11 32.1 0 0 0
Cross Reactivity (Analytical Specificity) and Microbial Interference
Cross reactivity and potential interference of BinaxNOW COVID-19 Antigen Self Test was evaluated
by testing 37 commensal and pathogenic microorganisms (8 bacteria, 14 viruses, 1 yeast and pooled
human nasal wash) that may be present in the nasal cavity. Each of the organism, viruses, and yeast were
tested in triplicate in the absence or presence of heat inactivated SARS-CoV-2 virus (45 TCID
50
/swab). No
cross-reactivity or interference was seen with the following microorganisms when tested at the concentration
presented in the table below.
Potential Cross-Reactant Test Concentration
Virus
Adenovirus 1.0 x 10
5
TCID
50
/mL
Human metapneumovirus (hMPV) 1.0 x 10
5
TCID
50
/mL
Rhinovirus 1.0 x 10
5
PFU/mL
Enterovirus/Coxsackievirus B4 1.0 x 10
5
TCID
50
/mL
Human coronavirus OC43 1.0 x 10
5
TCID
50
/mL
Human coronavirus 229E 1.0 x 10
5
TCID
50
/mL
Human coronavirus NL63 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 1 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 2 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 3 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 4 1.0 x 10
5
TCID
50
/mL
Influenza A 1.0 x 10
5
TCID
50
/mL
Influenza B 1.0 x 10
5
TCID
50
/mL
Respiratory Syncytial Virus A 1.0 x 10
5
PFU/mL
Potential Cross-Reactant Test Concentration
Bacteria
Bordetella pertussis 1.0 x 10
6
cells/mL
Chlamydia pneumoniae 1.0 x 10
6
IFU/mL
Haemophilus influenzae 1.0 x 10
6
cells/mL
Legionella pnuemophila 1.0 x 10
6
cells/mL
Mycoplasma pneumoniae 1.0 x 10
6
U/mL
Streptococcus pneumoniae 1.0 x 10
6
cells/mL
Streptococcus pyogenes (groupA) 1.0 x 10
6
cells/mL
Mycobacterium tuberculosis 1.0 x 10
6
cells/mL
Staphylococcus aureus 1.0 x 10
6
org/mL
Staphylococcus epidermidis 1.0 x 10
6
org/mL
Pooled human nasal wash N/A
Yeast Candida albicans 1.0 x 10
6
cells/mL
To estimate the likelihood of cross-reactivity with SARS-CoV-2 virus in the presence of organisms that
were not available for wet testing, In silico analysis using the Basic Local Alignment Search Tool (BLAST)
managed by the National Center for Biotechnology Information (NCBI) was used to assess the degree of
protein sequence homology.
• For P. jirovecii one area of sequence similarity shows 45% homology across 18% of the sequence,
making cross-reactivity in the BinaxNOW COVID-19 Antigen Self Test highly unlikely.
• No protein sequence homology was found between M. tuberculosis, and thus homology-based cross-
reactivity can be ruled out.
• The comparison between SARS-CoV-2 nucleocapsid protein, MERS-CoV and human coronavirus HKU1
revealed that cross-reactivity cannot be ruled out. Homology for KHU1 and MERS-CoV is relatively low,
at 37.8% across 95% of the sequence and 57.14% across 87% of the sequence, respectively.
High Dose Hook Eect
No high dose hook eect was observed when tested with up to a concentration of 1.6x10
5
TCID
50
/mL of
heat inactivated SARS-CoV-2 virus with the BinaxNOW COVID-19 Antigen Self Test.
Endogenous Interfering Substances
The following substances, naturally present in respiratory specimens or that may be artificially
introduced into the nasal cavity or nasopharynx, were evaluated with the BinaxNOW
COVID-19 Antigen Self Test at the concentrations listed below and were found not to affect
test performance.
Substance Active Ingredient Concentration
Endogenous
Mucin 2% w/v
Whole Blood 1% v/v
OTC Nasal Drops Phenylephrine 15% v/v
OTC Nasal Gel
Sodium Chloride
(i.e. NeilMed)
5% v/v
OTC Nasal Spray 1 Cromolyn 15% v/v
OTC Nasal Spray 2 Oxymetazoline 15% v/v
OTC Nasal Spray 3 Fluconazole 5% w/v
Throat Lozenge Benzocaine, Menthol 0.15% w/v
OTC Homeopathic Nasal Spray 1
Galphimia glauca, Sabadilla,
Lua opperculata
20% v/v
OTC Homeopathic Nasal Spray 2
Zincum gluconium
(i.e., Zicam)
5% w/v
OTC Homeopathic Nasal Spray 3 Alkalol 10% v/v
OTC Homeopathic Nasal Spray 4 Fluticasone Propionate 5% v/v
Sore Throat Phenol Spray Phenol 15% v/v
Anti-viral Drug
Tamiflu
(Oseltamivir Phosphate)
0.5% w/v
Antibiotic, Nasal Ointment Mupirocin
1
0.25% w/v
Antibacterial, Systemic Tobramycin 0.0004% w/v
1
Testing demonstrated false negative results at concentrations of 5 mg/mL (0.5% w/v). Standard dose of
nasal ointment: 20 mg (2% w/w) of mupirocin in single-use 1-gram tubes.
Usability Study
Abbott conducted a study to evaluate whether a home user can follow instructions and
successfully perform the test steps for the BinaxNOW COVID-19 Antigen Self Test,
including nasal swab collection at home, and correctly interpreting the results.
100 home users, including individuals (n=50) and caregivers (n=50), participated in the study. Each
individual or caregiver pair participated in a 60-minute session with a single proctor. The usability
evaluation session included one simulated use of the BinaxNOW COVID-19 Antigen Self Test and
opportunities to provide feedback.
92% (92 out of 100) home users produced a valid result (all negative) and 8 participants produced an
invalid result.
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, Maine 04074 USA
www.binaxnow-selftest.abbott
© 2023 Abbott. All rights reserved.
All trademarks referenced are trademarks of either the Abbott group of companies
ortheirrespective owners.
IN195151 Rev. 6 2023/11
SAP: 40004151
100% (99 out of 99) of the home (individual and caregiver) participants correctly understood that failure
to follow the test steps correctly would potentially lead to an invalid or inaccurate result or would require
another test or consultation with a healthcare provider. (One participant was inadvertently not asked this
question by the moderator during the session).
eInstruction Usability Study
The sponsor also submitted an usability study for the eInstruction. The goal of the usability
study was to demonstrate that lay users can use paper instructions or digital (mobile app or
website) instructions (i.e., paper Quick Reference Guide (QRG), digital app Quick Reference
Instructions (QRI), or website electronic Instructions for Use (eIFU)) to perform the test
steps for the BinaxNOW COVID-19 Antigen Self Test successfully.
The study was conducted at usability labs in Chicago, IL, USA on June 15 - June 23, 2021.
A total of 60 lay users, including individuals (n=30) and caregivers (n=30), participated in
the study. Each individual or caregiver pair participated in a 6-minute session with a study
moderator. The usability evaluation session included one simulated use of the BinaxNOW
COVID-19 Antigen Self Test, knowledge tasks, and opportunities to provide feedback.
SYMBOLS
This symbol indicates that the product is for single use only. It is not to be
re-used.
www.globalpointofcare.eifu.abbott
This symbol indicates that you should consult the instructions for use.
This symbol indicates that the product has a temperature limitation.
This symbol indicates the name and location of the product manufacturer.
This symbol indicates the product’s catalog number.
IVD
For In Vitro Diagnostic Use.
This symbol indicates the total number of tests provided in the kit box.
TECHNICAL SUPPORT ADVICE LINE
US
+ 1-833-637-1594 [email protected]
Abbott
BinaxNOW
COVID-19 Antigen Self Test
HCP PI - EN
Size:
Flat size: 17 in x 11 in
Folded size: 4.25 in x 5.50 in
Electronic Only
PN: IN195151
Rev: 6
SAP: 40004151
Incoming Inspection Colors
Date of Last Revision:
6.6 2023/11/15
PMS 2995 U
Primary Blue
PMS 224 U
Magenta-Pink
PMS 303 U
Dark Blue