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