BinaxNOW
™
COVID-19 Ag
CARD
Technical Support Advice Line
Further information can be obtained from your distributor, or by contacting
Technical Support on:
US +1 800 257 9525 [email protected]
PROCEDURE CARD
For Use Under an Emergency Use Authorization (EUA) Only.
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen to
SARS-CoV-2 directly from anterior nasal (nares) swab specimens.
IMPORTANT: See Product Insert, including QC section, for complete use instructions, warnings, precautions and limitations.
Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
False negative results may occur if specimens are tested past 1 hour of collection. Specimens should be tested as quickly as possible
after specimen collection. 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. Open the test card prior
to use, lay it flat, and perform assay as follows.
Part 1 - Sample Test Procedure
Patient Samples require 6 drops of Extraction Reagent.
Wrong
1
Correct
x6
Hold Extraction Reagent bottle vertically.
Hovering 1/2 inch above the TOP HOLE,
slowly add 6 DROPS to the TOP HOLE of the swab well.
DO NOT touch the card with the dropper tip while dispensing.
2
Insert sample or control swab into BOTTOM HOLE and firmly
push upwards so that the swab tip is visible in the TOP HOLE.
3
Rotate (twirl) swab shaft 3 times CLOCKWISE (to the right).
Do not remove swab.
4
15'
BinaxNOW
™
COVID-19 Ag
CARD
SAMPLE
CONTROL
Peel off adhesive liner from the right edge of the test card. Close and
securely seal the card. Read result in the window 15 minutes after
closing the card. In order to ensure proper test performance, it is
important to read the result promptly at 15 minutes, and not before.
Results should not be read after 30 minutes.
Used test cards should be discarded as
Biohazard waste according to Federal,
State and local regulatory requirements.
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 the
virus that causes 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.
BinaxNOW
™
COVID-19 Ag
CARD
Part 2 - Result Interpretation
Negative Result
Pink/Purple Control Line
A negative specimen will give a single pink/purple colored Control Line in the top half of the
window, indicating a negative result. This Control Line means that the detection part of the test
was done correctly, but no COVID-19 antigen was detected.
To increase the chance that the negative result for COVID-19 is accurate, you should:
• Test again in 48 hours if the individual has symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if the individual does not have symptoms on the
first day of testing.
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 tests. 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 SARSCoV-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.
Positive Result
Pink/Purple Control Line
Pink/Purple Sample Line
A positive specimen will give two pink/purple colored lines. Specimens with low levels of antigen
may give a faint Sample Line. Any visible pink/purple colored line is positive.
This 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 patient’s
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).
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 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.
Repeat testing does not need to be performed if patients have a positive result at any time.
Invalid Result
No Control Line
Blue Control Line Only
Blue Control Line
Sample Line Only
Sample Line
If no lines are seen, or if just the Sample Line is seen, the assay is invalid.
Invalid tests should be repeated with a new swab and a new test device.
BinaxNOW
™
COVID-19 Ag
CARD
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 Negive 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
Procedure for External Quality Control Testing
External Controls require 8 drops of Extraction Reagent
1. Hold Extraction Reagent bottle vertically. Hovering 1/2 inch above the TOP HOLE, slowly add 8 DROPS to
the TOP HOLE of the swab well. DO NOT touch the card with the dropper tip while dispensing.
2. Follow Steps 2 – 4 of the Test Procedure shown.
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, Maine 04074 USA
www.globalpointofcare.eifu.abbott
© 2023 Abbott. All rights reserved.
All trademarks referenced are trademarks of either
the Abbott group of companies or their respective owners.
IN195001-508 Rev. 3 2023/01
BinaxNOW
™
COVID19 Ag
CARD
BinaxNOW
™
COVID19 Ag
CARD
For Use Under an Emergency Use Authorization (EUA) Only
For use with anterior nasal (nares) swab specimens
For in vitro Diagnostic Use Only
INTENDED USE
The BinaxNOW
™
COVID-19 Ag Card is a lateral flow immunoassay intended
for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2
in direct anterior nasal (nares) swab samples collected by a healthcare provider
from individuals who are suspected of COVID-19 within seven (7) days of
symptom onset when tested at least twice over three days with at least 48 hours
between tests or from 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. Testing is limited to laboratories certified
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. §263a, that meet the requirements to perform moderate, high, or waived
complexity tests. This test is authorized for use at the Point of Care (POC), i.e.,
in patient care settings operating under a CLIA Certificate of Waiver, Certificate
of Compliance, or Certificate of Accreditation.
The BinaxNOW COVID-19 Ag Card 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. Laboratories within the United States and its territories
are required to report all results to the appropriate public health authorities.
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
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.
The BinaxNOW COVID-19 Ag Card is intended for use by medical
professionals or trained operators who are proficient in performing rapid lateral
flow tests. BinaxNOW COVID-19 Ag Card 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.
BinaxNOW COVID-19 Ag Card is a rapid lateral flow immunoassay for the
qualitative detection and diagnosis of SARS-CoV-2 directly from nasal swabs,
without viral transport media. The BinaxNOW COVID-19 Ag Card kit contains
all components required to carry out an assay for SARS-CoV-2.
PRINCIPLES of the PROCEDURE
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. 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 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.
REAGENTS and MATERIALS
Materials Provided
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 BinaxNOW COVID-19 Ag Card test
Positive Control Swab (1): Non-infectious recombinant SARS-CoV-2
nucleocapsid antigen dried onto a swab
Negative Control Swab: The use of a sterile patient swab ensures appropriate
negative results are obtained
Product Insert (1)
Procedure Card (1)
Materials Required but not Provided
Clock, timer or stopwatch
Materials Available as an Optional Accessory
Swab Transport Tube Accessory Pack
PRECAUTIONS
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.
1 BinaxNOW COVID-19 Ag Product Insert
4. Laboratories within the United States and its territories are required to
report all results to the appropriate public health laboratories.
5. Treat all specimens as potentially infectious. F
ollow universal precautions
when handling samples, this kit and its contents.
6. Proper sample collection, storage and transport are essential for correct
results.
7. Leave test card sealed in its foil pouch until just before use. Once opened the
test card should be used immediately.
8. Do not use if any of the test kit components or pouch is damaged or open.
9. Do not use kit past its expiration date.
10. Do not mix components from different kit lots.
11. Test components are single use. Do not re-use.
12. Inadequate or inappropriate sample collection, storage, and transport may
yield false test results.
13. Do not store or test specimens in viral transport media, as it may result in
false positive or false negative results.
14. All components of this kit should be discarded as Biohazard waste according
to Federal, State and local regulatory requirements.
15. Solutions used to make the positive control swab are non-infectious .
However, patient samples, controls, and test cards should be handled as
though they could transmit disease. Observe established precautions against
microbial hazards during use and disposal.
16. Wear appropriate personal protection equipment such as safety mask or face
covering and gloves when running each test and handling patient specimens.
Change gloves between handling of specimens suspected of COVID-19.
17. Do not read test results before 15 minutes or after 30 minutes. Results read
before 15 minutes or after 30 minutes may lead to a false positive, false
negative, or invalid result.
18. 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.
19. False Negative results can occur if the sample swab is not rotated (twirled)
prior to closing the card.
20. Swabs in the kit are approved for use with BinaxNOW COVID-19 Ag Card.
Do not use other swabs.
21. The Extraction Reagent packaged in this kit contains saline, detergents and
preservatives that will inactivate cells and virus particles. Samples eluted in
this solution are not suitable for culture.
22. Do not touch the swab tip. Do not store the swab after specimen collection in
the original paper packaging, if storage is needed use a plastic tube with cap.
23. 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.
24. If an individual has had symptoms longer than 7 days, they should consider
testing at least three times over five days with at least 48 hours between tests.
25. Do not use on anyone under 2 years of age.
26. Keep testing kit and kit components away from children and pets before and
after use. Avoid contact with your [e.g., skin, eyes, nose, or mouth]. Do not
ingest any kit components. The reagent solution contains harmful chemicals
(see table below). If the solution contacts your [e.g., skin, eyes, nose, or
mouth], flush with large amounts of water. If irritation persists, seek medical
advice: https://www.poisonhelp.org or 1-800-222-1222.
Chemical Name/CAS
Sodium
Azide/26628-22-8
GHS Code for each Ingredient
Acute Tox. 2 (Oral), H300
Acute Tox. 1 (Dermal), H310
Concentration
0.0125%
For more information on EUAs please visit: https://www.fda.gov/emergency-
preparedness-and-response/mcm-legal-regulatory-and-policy-framework/
emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/
COVID19
STORAGE and STABILITY
Store kit at 2-30°C. The BinaxNOW COVID-19 Ag Card kit is stable until the
expiration date marked on the outer packaging and containers. Ensure all test
components are at room temperature before use.
QUALITY CONTROL
BinaxNOW COVID-19 Ag Card has built-in procedural controls. For daily
quality control, Abbott suggests that you record these controls for each test run.
Procedural Controls:
A. The pink-to-purple line at the “Control” position is an internal
procedural control. If the test flows and the reagents work, this line will
always appear.
B. The clearing of background color from the result window is a negative
background control. The background color in the window should be light
pink to white within 15 minutes. Background color should not hinder
reading of the test.
External Positive and Negative Controls:
Good laboratory practice suggests the use of positive and negative controls to
ensure that test reagents are working and that the test is correctly performed.
BinaxNOW COVID-19 Ag Card kits contain a Positive Control Swab and
Sterile Swabs that can be used as a Negative Control Swab. These swabs will
monitor the entire assay. Test these swabs once with each new shipment received
and once for each untrained operator. Further controls may be tested in order to
conform with local, state and/or federal regulations, accrediting groups, or your
lab’s standard Quality Control procedures.
If the correct control results are not obtained, do not perform patient tests or
report patient results. Contact Technical Support during normal business hours
before testing patient specimens.
SPECIMEN COLLECTION and HANDLING
Test specimens immediately after collection for optimal test performance.
Inadequate specimen collection or improper sample handling/storage/
transport may yield erroneous results. Refer to the CDC Interim Guidelines
for Collecting, Handling, and Testing Clinical Specimens from Persons for
Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-
nCoV/lab/guidelines-clinical-specimens.html
Anterior Nasal (Nares) Swab
Only the swab provided in the kit is to be used for nasal swab collection.
To collect a nasal swab sample, carefully insert the entire absorbent tip of the
swab (usually ½ to ¾ of an inch (1 to 1.5 cm) into the nostril. Firmly sample the
nasal wall by rotating the swab in a circular path against the nasal wall 5 times or
more for a total of 15 seconds, then slowly remove from the nostril. Using the
same swab, repeat sample collection in the other nostril.
SPECIMEN TRANSPORT and STORAGE
Do not return the nasal swab to the original paper packaging.
For best performance, direct nasal swabs should be tested as soon as possible
after collection. If immediate testing is not possible, and to maintain best
performance and avoid possible contamination, it is highly recommended
the nasal swab is placed in a clean, unused plastic tube labeled with patient
information, preserving sample integrity, and capped tightly at room
temperature (15-30°C) for up to (1) hour prior to testing. Ensure the swab fits
securely within the tube and the cap is tightly closed. If greater than 1 hour delay
occurs, dispose of sample. A new sample must be collected for testing.
2 BinaxNOW COVID-19 Ag Product Insert
TEST PROCEDURE
Procedure for Patient Specimens
Open the test card just prior to use, lay it flat, and perform assay as follows.
The test card must be flat when performing testing, do not perform testing
with the test card in any other position.
1. Hold Extraction Reagent bottle vertically.
Hovering 1/2 inch above the TOP HOLE,
slowly add 6 DROPS to the TOP HOLE
of the swab well. DO NOT touch the card
with the dropper tip while dispensing.
x6
Correct
Wrong
2. Insert sample into BOTTOM HOLE and
firmly push upwards so that the swab tip is
visible in the TOP HOLE.
3.
Rotate (twirl) swab shaft 3 times
CLOCKWISE (to the right). Do not
remove swab.
Note:
False negative results can occur if the
sample swab is not rotated (twirled) prior to
closing the card.
4.
Peel off adhesive liner from the right edge
of the test card. Close and securely seal the
card. Read result in the window 15 minutes
after closing the card. In order to ensure
proper test performance, it is important to
read the result promptly at 15 minutes, and
not before. Results should not be read after
30 minutes.
Note: False negative results can occur if test
results are read before 15 minutes.
15'
BinaxNOW
™
COVID-19 Ag
CARD
SAMPLE
CONTROL
Note: When reading test results, tilt the
card to reduce glare on the result window if
necessary. Individuals with color-impaired
vision may not be able to adequately interpret
test results.
Procedure for BinaxNOW
™
Swab Controls
Open the test card just prior to use, lay it flat, and perform assay as follows.
1. Hold Extraction Reagent bottle vertically
Hovering 1/2 inch above the TOP HOLE,
slowly add 8 DROPS to the TOP HOLE
of the swab well. DO NOT touch the card
with the dropper tip while dispensing.
x8
Correct
Wrong
2. Follow Steps 2 – 4 of the Test Procedure
for Patient Specimens.
RESULT INTERPRETATION
Note: In an untested BinaxNOW COVID-19 Ag Card there will be a blue line present
at the Control Line position. In a valid, tested device, the blue line washes away and
a pink/purple line appears, confirming that the sample has flowed through the test
strip and the reagents are working. If the blue line is not present at the Control Line
position prior to running the test, do not use and discard the test card.
Negative
A negative specimen will give a single
pink/purple colored Control Line in
the top half of the window, indicating a
negative result. This Control Line means
that the detection part of the test was
done correctly, but no COVID-19
antigen was detected.
Pink/Purple Control Line
To increase the chance that the negative
result for COVID-19 is accurate, you
should:
• Test again in 48 hours if the
individual has symptoms on the first
day of testing.
• Test 2 more times at least 48 hours
apart if the individual does not have
symptoms on the first day of testing.
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 tests. 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.
3 BinaxNOW COVID-19 Ag Product Insert
Positive
A positive specimen will give two pink/
purple colored lines. Specimens with low
levels of antigen may give a faint Sample
Line. Any visible pink/purple colored line
is positive.
Pink/Purple Control Line
Pink/Purple Sample Line
This 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 patient’s 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).
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
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.
Repeat testing does not need to be performed if patients have a positive
result at any time.
Invalid
If no lines are seen, if just the Sample
Line is seen, or the Blue Control Line
remains blue, the assay is invalid. Invalid
tests should be repeated with a new swab
and a new test device.
No Control Line
Sample Line Only
Blue Control Line Only
Blue Control Line
Sample Line
TEST INTERPRETATION
Repeat testing is needed to improve test accuracy. Please follow the table below
when interpreting test results.
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
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.
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 Ag Card 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,
transported, or handled.
• False results may occur if specimens are tested past 1 hour of collection.
Specimens should be tested as quickly as possible after specimen collection.
• False negative results may occur if inadequate extraction buffer 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.
• Incorrect results may occur if a specimen is incorrectly collected or handled.
• Positive test results do not differentiate between SARS-CoV and SARS-
CoV-2.
• All COVID-19 antigen test negative results are presumptive and
confirmation with a molecular assay may be necessary. 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
Ag test and may cause false negative results.
• 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.
• If the differentiation 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 between January, 2021
and May, 2022. Clinical performance has not been established with 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.
4 BinaxNOW COVID-19 Ag Product Insert
• 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 as compared to a molecular
test, especially in samples with low viral load.
CONDITIONS of AUTHORIZATION for
LABORATORY and PATIENT CARE SETTINGS
The BinaxNOW COVID-19 Ag Card Letter of Authorization, along with the
authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for
Patients, and authorized labeling are available on the FDA website: https://www.
fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/in-vitro-diagnostics-euas.
However, to assist clinical laboratories using the BinaxNOW COVID-19 Ag
Card, the relevant Conditions of Authorization are listed below:
• Authorized laboratories using your product must include with test result
reports, all authorized Fact Sheets. Under exigent circumstances, other
appropriate methods for disseminating these Fact Sheets may be used,
which may include mass media.
• Authorized laboratories using your product must use your product as
outlined in the authorized labeling. Deviations from the authorized
procedures, including the authorized instruments, authorized clinical
specimen types, authorized control materials, authorized other ancillary
reagents and authorized materials required to use your product are not
permitted.
• Authorized laboratories that receive your product must notify the relevant
public health authorities of their intent to run your product prior to initiating
testing.
• Authorized laboratories using your product must have a process in place
for reporting test results to healthcare providers and relevant public health
authorities, as appropriate.
• Authorized laboratories will collect information on the performance
of your product and report to DMD/OHT7/OPEQ/CDRH (via
email: CDRH-EUA-R[email protected]) and Abbott Diagnostics
Scarborough, Inc. (via email: [email protected], or via phone by
contacting Abbott Diagnostics Scarborough, Inc. Technical Service
at 1-800-257-9525 any suspected occurrence of false positive or false
negative results and significant deviations from the established performance
characteristics of your product of which they become aware.
• All operators using your product must be appropriately trained in performing
and interpreting the results of your product, use appropriate personal
protective equipment when handling this kit, and use your product in
accordance with the authorized labeling.
• Abbott Diagnostics Scarborough, Inc., authorized distributors, and
authorized laboratories using your product must ensure that any records
associated with this EUA are maintained until otherwise notified by FDA.
Such records will be made available to FDA for inspection upon request.
The letter of authorization refers to, “Laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a,
that meet the requirements to perform high, moderate, or waived complexity
tests. This test is authorized for use at the Point of Care (POC), i.e., in patient
care settings operating under a CLIA Certificate of Waiver, Certificate of
Compliance, or Certificate of Accreditation.” as “authorized laboratories.”
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.
5 BinaxNOW COVID-19 Ag Product Insert
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 Ag Card
was evaluated in a multi-site 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
460nasal swabs collected from individual symptomatic patients (within 7 days
ofonset) 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
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 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 Ag
Card 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 wer
e 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.
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 different specimen pool and do
not indicate that a test will have different 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
6 BinaxNOW COVID-19 Ag Product Insert
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 9 30.1 0 0 0
Dilution 10 31.0 0 0 0
Dilution 11 32.1 0 0 0
ANALYTICAL PERFORMANCE:
Limit of Detection (Analytical Sensitivity)
BinaxNOW COVID-19 Ag Card limit of detection (LOD) was determined
by evaluating different 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/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 Ag Card LOD in natural nasal swab matrix
was confirmed as 140.6 TCID/mL in the test. Based upon the testing
procedure for this study, the LOD of 140.6 TCID/mL in the test equates
to 22.5TCID/swab.
Limit of Detection (LoD) Study Results
Concentration
TCID/mL
Number
Positive/Total
% Detected
140.6 20/20 100%
Cross Reactivity (Analytical Specificity) and Microbial Interference
Cross reactivity and potential interference of BinaxNOW COVID-19Ag
Card was evaluated by testing 37 commensal and pathogenic microorganisms
(8bacteria, 14viruses, 1yeast 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 (45TCID/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 10⁵ TCID/mL
Human metapneumovirus (hMPV) 1.0 x 10⁵ TCID/mL
Rhinovirus 1.0 x 10⁵ PFU/mL
Enterovirus/Coxsackievirus B4 1.0 x 10⁵ TCID/mL
Human coronavirus OC43 1.0 x 10⁵ TCID/mL
Human coronavirus 229E 1.0 x 10⁵ TCID/mL
Human coronavirus NL63 1.0 x 10⁵ TCID/mL
Human parainfluenza virus 1 1.0 x 10⁵ TCID/mL
Human parainfluenza virus 2 1.0 x 10⁵ TCID/mL
Human parainfluenza virus 3 1.0 x 10⁵ TCID/mL
Human parainfluenza virus 4 1.0 x 10⁵ TCID/mL
Influenza A 1.0 x 10⁵ TCID/mL
Influenza B 1.0 x 10⁵ TCID/mL
Respiratory Syncytial Virus A 1.0 x 10⁵ PFU/mL
Potential Cross-Reactant Test Concentration
Bacteria
Bordetella pertussis 1.0 x 10⁶ cells/mL
Chlamydia pneumoniae 1.0 x 10⁶ IFU/mL
Haemophilus influenzae 1.0 x 10⁶ cells/mL
Legionella pnuemophila 1.0 x 10⁶ cells/mL
Mycoplasma pneumoniae 1.0 x 10⁶ U/mL
Streptococcus pneumoniae 1.0 x 10⁶ cells/mL
Streptococcus pyogenes (group A) 1.0 x 10⁶ cells/mL
Mycobacterium tuberculosis 1.0 x 10⁶ cells/mL
Staphylococcus aureus 1.0 x 10 org/mL
Staphylococcus epidermidis 1.0 x 10 org/mL
Pooled human nasal wash N/A
Yeast Candida albicans 1.0 x 10⁶ 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-19Ag Card 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.
7 BinaxNOW COVID-19 Ag Product Insert
High Dose Hook Effect
No high dose hook effect was observed when tested with up to a concentration
of 1.6 x 10 TCID/mL of heat inactivated SARS-CoV-2 virus with the
BinaxNOW COVID-19 Ag Card.
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 Ag Card 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,
Luffa 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
Substance Active Ingredient Concentration
Anti-viral Drug
Tamiflu
(Oseltamivir Phosphate)
0.5% w/v
Antibiotic, Nasal
Ointment
Mupirocin 0.25% w/v
Antibacterial,
Systemic
Tobramycin 0.0004% w/v
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.
SYMBOLS
Prescription Only
ORDERING and CONTACT INFORMATION
Reorder Numbers:
195-000: BinaxNOW COVID-19 Ag Card (40 Tests)
195-080: BinaxNOW COVID-19 Ag Control Swab Kit
190-010: Swab Transport Tube Accessory Pack
US +1 877 441 7440
Technical Support Advice Line
Further information can be obtained from your distributor, or by contacting
Technical Support on:
US
+ 1 800 257 9525 [email protected]
8 BinaxNOW COVID-19 Ag Product Insert
