Abbott COVID-19 Ag CARD 2 Home Test Kit Instruction Manual

2

COVID-19 Ag CARD 2 HOME TEST KIT - US Food and Drug ...

2021-03-30 — This product has not been FDA cleared or approved but has been authorized by FDA under an EUA. • This product has been authorized only for the detection of ...

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BinaxNOWTM
COVID-19 Ag CARD 2 HOME TEST KIT
PROCEDURE CARD
DO NOT OPEN ITEMS UNTIL INSTRUCTED TO DO SO

The BinaxNOWTM COVID-19 Ag Card 2 Home Test is for FDA Emergency Use Authorization (EUA) Only
For In Vitro Diagnostic (IVD) Use
� This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.
� 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 isonlyauthorized forthe duration ofthe declaration that circumstances exist justifying the authorization of emergency use of IVDs 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.
� For more information on EUAs go here: https://w w w .fda.gov/emergency-prepare dnessand-response/mcm-legal-regulatory-and-policy-framew ork/emergency-use-authorization
� For the most up to date information on COVID-19, please visit:w w w .cdc.gov/COVID19
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

� For detailed instructions, please visit: BinaxNOWhometest.abbott.com
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Frequently Asked Questions

Will this test hurt?
No, the nasal swab is not sharp and it should not hurt. Sometime s the swab can feel slightly uncomfortable or tickly. Ifyou feel pain, please stop the test and seek advice from a healthcare provider.

What are the known and potential risks and benefits of thistest?

Potential risks include:
� Possible discomfort during sample collection. � Possible incorrect test results (see Results section).
Potential benefits include:
� The results, along with other information, can help your healthcare provider make informed recomm endations about your care.
� The results of this test may help limit the spread of COVID-19 to your family and others in your community.

Hazardous Ingredients for the Reagent Solution

Chemical Name/CAS GHS Code for each Ingredient Concentration

Sodium Azide/26628-22-8 Acute Tox. 2 (Oral), H 300 Acute Tox. 1 (Dermal), H310

0.0125%

The solution in the tube contains a hazardous ingredient (see table above). Ifthesolutioncontactstheskinoreye, flushwith

plenty of water. If irritation persists, seek medical advice.
http://w w w .poison.org/c ont a ct -us or 1-800 -2 2 2 -1 2 2 2 .
What is the difference between an antigen and molecular test?
There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whethe r an additiona l molecula r test would help with your care, and w hen you should discontinue home isolation.
How Accurate is thisTest?
Based on the interim results of a clinical study w here the BinaxN OWTM COVI D-19 Ag Card 2 Home Test was compa red to an FDA authorized high sensitivity SARS-CoV-2 test, BinaxNOW COVID-19 Ag Card 2 Home Test correctly identified 91.7% of positive specimens and 100% of negative specimens.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Frequently Asked Questions

Due to the relatively small sample size for the home use clinical study, the BinaxNOW COVID-19 Ag Card 2 Home Test is estimated to correctly identify between 73.0% and 98.9% of positive specimens as reflected inthe 95% Confidence Interval. This is consistent with the performance established in a separate multi-site clinical study in the US, w here 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 correctly identified 84.6% of positive specimens and 98.5% of negative specimens.
The performance of this test is still being studied in patients w ithout signs and symptoms of respiratory infection and for serial screening. Performance may differ in these populations.
Based on this informa tion, negative results may require additiona l testing to confirm your result. Please talk to your healthcare provider to determine if you need additional testing.

What is Serial Testing?
COVID-19 Serial testing is w hen one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Indication

The BinaxNOW COVID-19 Ag Card 2 Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection w hen tested tw ice over three days w ith at least 36 hours between tests. This test is authorized for non-prescription home use with self- collecte d observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected nasal swab samples from individuals aged two years or older.
The BinaxNOW COVI D-19 Ag Card 2 Home Test is to be performed only with the supervision of a telehealth proctor.
The BinaxNOW COVI D-19 Ag Card 2 Home Test does not different iat e betw een SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnost ic information is necessary to determine infection status. Positive results do not rule out bacteria l infection or co-infe c tion with othe r viruses. The agent detected may not be the definite cause of disease. Individuals w ho test positive w ith the BinaxNOW

COVID-19 Ag Card Home Test should self-isolate and seek follow -up care w ith their physician or healthcare provide r as additional testing may be necessary.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

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 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. For serial testing programs, additional confirmatory testing w ith a molecular test for negative results may be necessary, if there is a high likelihood of COVID-19, such as, an individual w ith a close contact w ith COVID-19 or w ith suspected exposure to COVID-19 or in communities w ith high prevalence of infection. Additional confirmatory testing w ith a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals w ithout know n exposures to COVID-19 or residing in communities w ith low prevalence of infe c t ion.

Aut horiza t ion.
The telehealth provider 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.

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.

The BinaxNOW COVID-19 Ag Home Test is intended for observed non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting. The BinaxNOW COVID-19 Ag Card 2 Home Test is only for use under the Food and Drug Administration's Emergency Use
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Wash Your Hands
Wash or sanitize your hands. Make sure they are dry before starting.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Set Up
It is recommended gloves (not provided) also be used during testing.

Open your test kit. You w ill need the follow ing to perform a test:

1 Swab

1Test Card

1 Bottle

O NTRO L AMPLE
naxNO
RD

or

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Open Pouch and Scan QR Code on Card

If usinga mobile device:

If using a computer:

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Open Card

Top Hole Bottom Hole

Results Window

Test Strip

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

DO NOT
touch any parts on inside of card.

Apply Fluid to Top Hole

A. Remove dropper bottle cap.

B. Hold dropper bottle straight overTOPHOLE, not at an angle.

C. Put 6 DROPS into TOP HOLE. Do not touchcard with tip.

6 drops

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Note: False negative results may occuriflessthan6drops

of fluid is used.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Open Swab

! Keep fingers away from swab end.
A. Open swab package at stick end.

B. Take sw ab out.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Swab Left Nostril

A. Insert the entire absorbent tip of the sw ab (usually 1/2 to 3/4 of an inch) into left nostril.

B. Firmly brush against insidesof nostrilina circularmotion5 times ormoreforat least15 seconds.

Up to 3/4 of

x5

an inch.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Swab Right Nostril

A. Remove swab and insert it into right nostril.

B. Firmly brush against insidesof nostrilina circularmotion5 times ormoreforat least15 seconds.

x5
Note: False negative results may occurifthe nasalswabisnot properly collected.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Insert Swab into Bottom Hole

Insert s fills TOP

until tip

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Turn Swab 3 Times
Turn sw ab to right 3 times in card and leave it in place.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Peel Strip
Keep sw ab in place. Peel adhesive liner off.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Close Card and Seal
Close left side ofcardoverswabtosealit. Keepcardface upontable.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Scan QR Code

If usinga mobile device:

If using a computer:

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Show Result to Your Proctor

CONT ROL SAMPLE
BinaxNOWTM
COVID-19 Ag CARD

CON T RO L SAMPLE

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Steps to Check Your Results
There are three types of results possible. You will be instructed how to read eachtype in a specific order. Follow this orderw ithyourproctor:
1. Check for a Positive Result 2. Check for a Negative Result 3. Check for an Invalid Result
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Check for Positive COVID-19 Result

Findresult w indow and look carefully for tw o pink/purple linesin w indow .

� Positive Result: Tw o pink/purple lines w ill appear. One on the top half and one on the bottom half. COVID-19 was detected.

Positive

Positive

CONTROL OR
SAMPLE

Solid Line

Faint Line

Look very closely!
The bottom line canbe very faint. Any pink/purple line visible here indicates a positive result.

Here are photos of actual positive tests. On the right, note how faint the bottom line can get.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Positive COVID-19Result
A positive test result means it isvery likely you have COVID-19 and it is important to be under the care of your healthcare provider. The telehealth proctor is not a healthcare provider. It is also likely that you may be placed in isolation to avoid spreading the virus toothers. There isa verysmallchance that thistest can give a positive result that is wrong (a false positive result). If you test positive with the BinaxNOW COVID-19 Ag Card 2 Home Test kit, you should self-isolate and seek follow-up care with your healthcare provider. Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Check for Negative COVID-19 Result

Find result w indow and look for a single pink/purple line in w indow . � Negative Result: A single pink/purple line on the tophalf w here it says "Control." COVID-19 was not detected.
Negative
CONTROL

SAMPLE

No Line

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Negative COVID-19 Result

A negative test result means that proteins from the virusthat causes COVID-19 were not found in your sample.
It is possible for this test togive a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If you test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healt hcare provider. Please consult your healthcare professional if you develop symptoms, symptoms persist or become more severe.

The telehealth proctor is not a healthcare provider. Your healthcare provider will consider the test result together withall other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. For example, your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19.
If you or the telehealth proctor disagree on the presence of a faint line and/or the presence of a line is uncertain, additional testing should be c onduc t e d.
It is important that you work with your healthcare provider to help you understand the next steps you should take.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

What do I need to know about Results from Serial Testing?
If your first test is negative, you should test again in 24-36 hours.
If your first or second test is positive, then proteins from the virus that causes COVID-19 have been found in your specimen and you likely have COVID-19. If you test positive with the BinaxNOW COVID-19 Ag Card 2 Home Test with either test, you should self-isolate and seek follow-up care with your healthcare provider to determine the next steps you should take. You may need additional testing, depending on your personal health history and other factors.

If both your first and second tests are negative, you may not have COVID-19, however, you should follow-up with your healthcare provider if you are at high risk for COVID-19 infection or have known contacts with COVID-19. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID19 or need other testing.

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Check for Invalid Result

If you see any of these, the test is invalid.

No lines seen
CONTROL

Blue control line only

Pink/purple sample line only

Blue control line AND pink/purple sample line

SAMPLE

REMEMBER: A second BinaxNOW COVID-19 Ag Card 2 Home Test is required to be performed within 3 days with at least 36 hours between tests.
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Dispose in Trash
BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Reporting Patient Results Using NAVICA
Upon completion of the test and result interpretation, the telehealth proctor will send your test results via the NAVICA app. You w ill be notified by email and on your mobile device that your
results are ready. You w ill go to the results screen in NAVICA to obtain your test results.

If your BinaxNOW COV ID-19 Ag Card 2 Home Test result is Negative, you w ill receive the follow ing:

If your BinaxNOW COV ID-19 Ag Card 2 Home Test result is Positive, you w ill receive the follow ing:

BinaxNOW COVI D-19 Ag CARD 2 HOME TEST KI T

Reporting Patient Results Using NAVICA
Upon completion of the test and result interpretation, the telehealth proctor will send your test results via the NAVICA app. You w ill be notified by email and on your mobile device that your
results are ready. You w ill go to the results screen in NAVICA to obtain your test results.
If the BinaxNOW COV ID-19 Ag Card 2 Home Test result is Invalid, you w ill receive the follow ing:

� 2021 Abbott. All rights reserved. All t rademarks referenced are t rademarks of eit her t he Abbott group of companies or their respective ow ners.
I N1 9 5 1 0 6 Re v 1 2 0 2 1 /0 3

BinaxN OW COVID-1 9 Ag CARD 2 HOME TEST KIT

Abbott BinaxNOW COV ID-19 Ag Card 2 Home Test
Procedure Card
Size: 16.35 in. x 12.21 in.

Colors
RGB
For Reference Only
PMS 2995 C P rimary Blue PMS 303 C
Dark Blue PMS 224 C M agent a-P ink

PN: IN19 5 1 0 6 Rev: 1
Date of Last Revision: 1.3 2021/03/2 6