BinaxNOW COVID-19 At Home Test Instruction Manual

BinaxNOW COVID-19 At Home Test Instruction

Manual

BinaxNOW COVID-19 At Home Test Instruction Manual

DO NOT OPEN ITEMS UNTIL INSTRUCTED TO DO SO

The BinaxNOW TM COVID-19 Ag Card Home Test is for FDA EmergencyUseAuthorization(EUA)Only

For Prescription Use 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 SARSCoV-2, not for any other viruses or pathogens; and,

• This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/r diagnosis of COVID-19 under Section 564(b (1)federalization,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://www.fda.gov/emergency-preparednessand-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

• For detailed instructions, please visit : BinaxNOWhometest.abbott.com

Frequently AskedQuestions

Will this testhurt?

No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider.

What are the known and potential risks and benefits of this test?

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 recommendations about your care.
• There results of this test may help limit the spread of COVID-19 to your family and others in your community.

You have the option to refuse this test. However, your doctor has prescribed this test because they believe it could help with your care.

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 whether an additional molecular test would help with your care, and when you should discontinue home isolation.

How Accurate is this Test?

Based on the interim results of a clinical study where the BinaxNOWTM COVID-19 Ag Card Home
Test was compared toan FDA authorized high sensitivity SARS-CoV-2test,BinaxNOW COVID-19 Ag Card Home Test correctly identified 91.7% of positive specimens and 100% of negative specimens.

BinaxNOW COVID-19 Ag Card Home Test Study*

In the graph above, BLUE bars represent samples where the both the BinaxNOW COVID-19 Ag Card Home Test and molecular test result were positive. The ORANGE bars represent samples where the BinaxNOW COVID-19 Ag Card Home Test results that were negative and the molecular test was positive. All of the ORANGE bars occurred in samples where there were very low levels of virus detected by the molecular test. In a separate larger study, the BinaxNOW COVID-19 Ag Card clinical study where tests were performed by healthcare providers, BinaxNOW COVID-19 Ag Card correctly identified 90.6% (116/128) positive specimens with high amounts of virus.
Due to the relatively small sample size for the home use clinical study, the BinaxNOW™ COVID-19 Ag Card Home Test is estimated to correctly identify between 73.0% and 98.9% of positive specimens as reflected in the 95% Confidence Interval. This is consistent with the performance established in a separate multi-site clinical 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 correctly identified 84.6% of positive specimens
and 98.5% of negative specimens.
Based on this information, negative results may require additional testing to confirm your result.
Please talk to your healthcare provider to determine if you need additional testing.

Indication

The Binax NOW COVID-19Ag Card Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This tests authorized for prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID19 by their healthcare provider within the first seven days of symptom onset or adult-collected nasal swab samples from individuals aged four years or older whoa re suspected of COVID-19by their health care provider with in the first seven days of symptom onset. The BinaxNOWCOVID-19AgCard Home Test is to be performed only with the supervision of a tele health proctor.
TheBinaxNOWCOVID-19AgCard Home Test 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 in fectionorco-infection with other viruses. The agent detected may not be the definite cause of disease. 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. individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. BinaxNOWCOVID-19AgCard Home Test isonly foruse under the Food and Drug Administration’s Emergency Use Authorization. All prescribing 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.

Wash Your Hands

Wash or sanitize your hands. Make sure they are dry before starting.

1.Set Up

DO NOT open items until instructed.

A. Open your test kit

B.You should have:

2.Open Pouch and Scan QR Code on Card

3.Open Card

4.Apply Fluid to Top Hole

A. Remove dropper bottle cap.
B. Hold dropper bottle straight over TOP HOLE, not at an angle.
C. Put 6 DROPS into TOP HOLE. Do not touch card with tip

5.Open Swab

A. Open swab package at stick end.
B. Take swab out.

6.Swab Left Nostril

A. Insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into left nostril.
B. Firmly brush against insides of nostril in a circular motion 5  times or more for at least 15 seconds.

7.Swab Right Nostril

A. Remove swab and insert it into right nostril.
B. Firmly brush against insides of nostril in a circular motion 5 times or more for at least 15 seconds.

8.Insert Swab Into Bottom Hole

Insert swab tip into BOTTOM HOLE and firmly push up until tip fills TOP HOLE

9.Turn Swab 3 Times

Turn swab to right 3 times in card and leave it in place

10.Peel Strip

Keep swab in place. Peel adhesive liner off.

11.Close Card And Seal

Close left side of card over swab to sea lit. Keep card face up on table.

12.Wait 15 Minutes

_ Note: False results can occur _if the card is disturbed/moved or test results are read before 15 minutes.

13.Scan QR Code

14.Show Result to YourProctor

15. Steps To Check Your Results

There are three types of results possible. You will be instructed how to read each type in a specific order. Follow this order with your proctor:

1. Check for a Positive Result
2. Check for a Negative Result
3. Check for an Invalid Result

16.Check for Positive COVID-19 Result

Find result window and look carefully for two pink/purple lines in window.
•Positive Result: Two pink/purple lines will appear. One on the top
half and one on the bottom half. COVID-19 was detected.

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

Positive COVID-19Result

A positive test result mean sit is very likely you have COVID-19 and it is important to be under the care of your health care 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 is a very small chance that this test can give
a positive result that is wrong (a false positive result). 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.

17.Check for Negative COVID-19 Result

Find result window and look for a single pink/purple line in window.
• Negative Result: A single pink/purple line on the top half
where it says“Control.”COVID-19 was not detected.

Negative COVID-19Result

A negative test result means that proteins from the virus that
causes COVID-19 were not found in your sample.
Negative results may require additional molecular
testing to confirm that you do not have COVID-19.
It is possible for this test  to give 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 your test result is negative, please consult your
healthcare provider. The telehealth proctor is not a
healthcare provider. Your health care provider will consider the
test result together with all 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. If you or the healthcare proctor disagree on the presence of a faint line and/or the presence of a line is uncertain, additional  BinaxNOWCOVID 19Ag CARD HOME TEST KIT confirmatory testing should be conducted. It is important that you work with your health care provider to help you understand the next steps you should take.

18.Check for Invalid Result

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

19.Dispose in Trash

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

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 will be notified by email and on your mobile device that your results are ready. You will go to the results screen in NAVICA to obtain your test results.

If the BinaxNOW COVID-19 Ag Card Home Test result is In valid,you will receive the following:

BinaxNOW COVID-19 At Home Test Instruction Manual – Optimized PDF
BinaxNOW COVID-19 At Home Test Instruction Manual – Original PDF

FAQS

Abbott, not customers: what is the difference between this antigen self test and the binaxnow covid-19 ag card home test?

The BinaxNOW COVID-19 Antigen Self Test does not currently pair with the NAVICA app. The BinaxNOW COVID-19 Home Test can provide a sharable digital COVID-19 result, through collaboration with eMed. The BinaxNOW COVID-19 Antigen Self Test is the identical test card to the professional test but can be purchased at retail locations without a prescription. There’s also no need for a healthcare professional or online proctor to administer the swab or interpret results. Please let us know if there is anything else we can help you with.

Waiting for customer reviews. How accurate is the test?

This is an antigen test, not as accurate as a PCR molecular test. Depends on the viral load in your nasal passages. If positive you are likely infected with Covid. If negative and have symptoms test again and get a PCR test.

does it test for antibodies?

No, this is an antigen test that only detects an active infection. Antibody tests can detect past infections. Please let us know if there is anything else we can help you with.

What are the specificity and sensitivity ratings for this test?

Based on the interim results of a clinical study where the BinaxNOW™ COVID-19 Antigen Self Test was compared to an FDA authorized high sensitivity SARS- CoV-2 test, BinaxNOW COVID-19 Antigen Self Test correctly identified 84.6% of positive specimens and 98.5% of negative specimens.

False positive and false negative rates for the test?

Based on the interim results of a clinical study where the BinaxNOW™ COVID-19 Antigen Self Test was compared to an FDA authorized high sensitivity SARS- CoV-2 test, BinaxNOW COVID-19 Antigen Self Test correctly identified 84.6% of positive specimens and 98.5% of negative specimens.

To mfg: So many customers getting unsealed boxes–are new tests being put in old boxes? My lot # on box doesn’t match the lot # on tests inside

my box was sealed and a new test. The reactant agent, not sure if that is what you call it was sealed as well. I ordered two boxes, so 4 test total, did not have an issue.

Can this test be administered through the mouth with saliva rather than the nose?

Our BinaxNOW Self Test is simple. Each test kit includes step-by-step instructions and a quick reference guide with illustrations. You perform a minimally invasive nasal swab and all materials required to perform the test come in the box, with the exception of a timer.

Is this item hsa/fsa eligible?

That’s up to individual insurance companies to determine. Some cover other Over-the-Counter products so individuals would need to reach out to their provider to determine coverage.

Why did Abbott stop making this test?

We are producing millions of rapid tests per month here in the U.S. and, as we have been throughout the entire pandemic, are committed to making rapid tests available to more people at affordable prices and convenient places.

What is the QR code on the results card for?

The QR code on a BinaxNOW COVID-19 test card is used by NAVICA, Abbott’s COVID-19 digital testing system. NAVICA can be used to easily capture, manage and share self reported results from the BinaxNOW COVID-19 Antigen Self Test. It is available at no cost on the App Store or Google Play.

How are the swabs sterilized?

They come in a sealed packet

is there any part of the test kit that would get confiscated at TSA airport screening

The BinaxNOW COVID-19 Antigen Self Test can be taken on airplanes as there is nothing hazardous in the kit and the ampoule of extraction reagent is well under the 3 ounce liquid restriction.

Is it able to detect breakthrough infections in vaccinated people?

We are monitoring the mutations of the COVID-19 virus to ensure our tests can detect them, as we do with many viruses. We have conducted a thorough analysis of known variants that we’ve been able to study, and we are confident that our tests remain effective at identifying these strains.

For Abbot only, how accurate is this test (expressed as a sensitivity percentage) at detecting Covid-19 in an asymptomatic individual?

Based on the results of a clinical study where the BinaxNOW™ COVID-19 Antigen Self Test was compared to an FDA authorized high sensitivity SARS-CoV-2 test, BinaxNOW COVID-19 Antigen Self Test correctly identified 84.6% of positive specimens and 98.5% of negative specimens.

What do I do if my nasal passages are blocked?

If your nasal passages are blocked, please follow these steps:

1. Blow your nose before you take the test.
2. Take a decongestant (such as SudafedTM) at least 30 minutes before you take the test.
3. Take a decongestant (such as SudafedTM) after you have taken the test.
4. If you still have trouble breathing, contact your healthcare provider.

What do I do if I am sick?

If you are sick, please follow these steps:

1. Wait until you are better before taking this test.
2. Take a decongestant (such as SudafedTM) at least 30 minutes before you take this test.
3. Take a decongestant (such as SudafedTM) after you have taken this test.
4. If you still have trouble breathing, contact your healthcare provider.

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