Test Procedure

Result and Interpretation

Test

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Prepare for the Test

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Read this instruction guide carefully prior to starting test.

Prepare a watch (or a clock/timer), tissue, hand sanitizer or soap and warm water.

Check the test kit contents. Make sure that nothing is missing, damaged, or broken.

1.

2.

3.

For Anterior nasal specimens

For in-vitro diagnostic use

For use under emergency use authorization (EUA) only

NOTE: The test results should

not be read after 30 minutes.

Catalog number: BTK-H2201, BTK-H2202, BTK-H2205, BTK-H2220

Swabbing both nostrils is critical for obtaining an accurate result. If you do not swab both nostrils, the device will produce a false negative result.

IMPORTANT

IMPORTANT

www.bioteke-usa.com COVID-19 Antigen Home Test User Instructions

Wash your hands thoroughly for at

least 20 seconds before the test.

Locate sample tube and

place in box holder. Gently

peel off the aluminum foil

seal.

NOTE: Please blow your

nose before collection.

Remove the swab from its

wrapper, being careful not

to touch the fabric tip of

the swab with your hands.

Unpack components, and place on a flat, clean surface.

Gently insert the swab no more than 3/4 inch into the left nostril. Slowly

rotate the swab at least 5 times in a circular path for a total of 15

seconds. Gently remove the swab from the left nostril and place into

the right nostril. Repeat the process of rotating at least 5 times in a

circular path for 15 seconds. Remove the swab from the right nostril.

Insert the swab into the sample tube. Touch the bottom of the

sample tube with the swab tip, and stir at least 5 times.

Squeeze the swab in the tube through the outer wall of the

tube by finger 5 times.

Screw the purple tube cap onto

the sample tube and then unscrew

the top white cap.

Take out the test cassette. Place it on a flat, dry and clean

surface. Turn the sample tube upside down and slowly squeeze 3

drops onto the sample well of the test cassette.

Remove the swab by rotating against the sample tube while

squeezing the sides of the tube to release the liquid from the

swab. Remove and discard the swab into waste bag provided.

Please read the results

between 15 - 30 minutes

afterthe sample is dropped.

All used test components

should be disposed of in

your household waste.

After completing all

steps, wash hands or

use hand sanitizer.

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.

If the Control (C) Line is visible, but the Test (T) Line is not visible, the test is

negative. To increase the chance that the negative result for COVID-19 is

accurate, you should:

A negative test result indicates that the virus that causes COVID-19 was not detected in your

sample. A negative result is presumptive, meaning it is not certain that you do not have

COVID-19. You may still have COVID-19 and you may still be contagious. There is a higher

chance of false negative results with antigen tests compared to laboratory-based tests such as

PCR. If you test negative and continue to experience COVID-19-like symptoms, (e.g., fever,

cough, and/or shortness of breath) you should seek follow up care with your health care

provider.

COVID-19 Positive [+]

COVID-19 Negative [-]

Invalid

If the Control (C) Line and the Test (T) Line

are visible, the test is positive. Any faint

visible pink/purple Test (T) Line with the

Control (C) Line should be read as positive.

You do not need to perform repeat testing if you have a positive result at any time. A

positive test result means that the virus that causes COVID-19 was detected in your sample

and it is very likely you have COVID-19 and are contagious. Please contact your

doctor/primary care physician or your local health authority immediately and 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).

If the Control (C) Line is not visible the test is invalid. Retest with a new swab and new test device.

IMPORTANT

NOTE: With children, the maximum depth of insertion into the nostril may be less than 3/4 inch.

Note: Repeat testing is needed if your first result is negative,

please refer to the Result and Interpretation section.
Possible discomfort during sample collection.

Possible incorrect test result (see Warnings and Result Interpretation

sections for more information).

The results, along with other information, can help you and your healthcare

provider make informed recommendations about your care.

The results of this test may help limit the potential spread of COVID-19 to

your family and others in your community. For more information on EUAs go

here: https://www.fda.gov/emergency-preparedness-and-response/ mcmlegal-regulatory-and-policy-framework/emergency-use-authorization

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

Potential risks include:

Potential benefits include:

What is the difference between an antigen and molecular test?

There are different kinds of tests for the SARS-CoV-2 virus that causes

COVID-19. Molecular tests detect genetic material from the virus. Antigen tests,

such as the Bio-SelfTM COVID-19 Antigen Home Test, detect proteins

from the virus. Due to the lower sensitivity of antigen tests, there is a

higher chance this test will give you a false negative result when you have

COVID-19 than a molecular test would.

How accurate is this test?

Clinical studies have shown that antigen tests more accurately determine

whether you are infected with the virus that causes COVID-19 when taken

multiple times across several days. Repeat testing improves test accuracy. This

serial testing approach is recommended to minimize the risk of incorrect results.

For more information on the performance of the test and how the performance

may apply to you, please refer to the performance data in the Healthcare

Provider Instructions for Use (IFU), available at https://www.bioteke-usa.com/.

What if I have a positive test result?

A positive result means that it is very likely you have COVID-19 because proteins

from the virus that causes COVID-19 were found in your sample. You should

self-isolate from others and contact a healthcare provider for medical advice

about your positive result.

What if I have a negative test result?

A negative test result indicates that antigens from the virus that causes

COVID-19 were not detected in your sample. However, if you have symptoms of

COVID-19, and your first test is negative, you should test again in 48 hours since

antigen tests are not as sensitive as molecular tests. If you do not have

symptoms and received a negative result, you should test at least two more times

with 48 hours in between tests for a total of three tests. If you have a negative

result, it does not rule out SARS- CoV-2 infection; you may still be infected and

you may still infect others. It is important that you work with your healthcare

provider to help you understand the next steps you should take.

What does an invalid test result mean?

An invalid result means the test was not able to tell if you have COVID-19 or not.

If the test is invalid, a new swab should be used to collect a new nasal specimen

and you should test again with a new test.

Important

Do not use this test as the only guide to manage your illness. Consult your

healthcare provider if your symptoms persist or become more severe. Individuals

should provide all results obtained with this product to their healthcare provider.

Result and Interpretation Continued

Intended Use

How to Use This Test

Frequently Asked Questions

Warnings, Precautions and Safety Information

Hazardous Ingredients for Liquid Reagent

Bio-SelfTM

Repeat testing is needed to improve test accuracy. Please follow the table below when

interpreting test results 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. Report your

test result(s) at MakeMyTestCount.Org – this voluntary and anonymous reporting helps

public health teams understand COVID-19 spread in your area and across the country

and informs public health decisions.

Serial testing should be performed in all individuals with negative results;

individuals with symptoms of COVID-19 and initial negative results should be

tested again after 48 hours. Individuals without symptoms of COVID-19, and with

initial negative results, should be tested again after 48 hours and, if the 2nd test is

also negative, a 3rd time after an additional 48 hours. You may need to purchase

additional tests to perform this serial (repeat) testing.

If you test negative but continue to have symptoms of COVID-19, and both your

first and second tests are negative, you may not have COVID-19, however you

should follow-up with your healthcare provider.

If your test is positive, then proteins from the virus that causes COVID-19 have

been found in your sample and you likely have COVID-19.

The Bio-SelfTM COVID-19 Antigen Home Test is a lateral flow immunoassay intended

for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.

This test is authorized for non-prescription home use with self-collected anterior nasal

(nares) swab samples from individuals aged 14 years or older or adult- collected

anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is

authorized for individuals with symptoms of COVID-19 within the first 7 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 Bio-SelfTM COVID-19 Antigen Home Test does not differentiate 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) swab specimens during the acute phase

of infection. Positive results indicate the presence of viral antigens, but clinical

correlation with past medical history and other diagnostic information is necessary to

determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses and the agent detected may not be the definitive cause of

disease. Individuals who test positive with the Bio-SelfTM COVID-19 Antigen Home

Test should self-isolate and seek follow-up care with their physician or healthcare

provider as additional testing may be necessary.

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 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 have SARS-CoV-2 infection and should

seek follow-up care from their healthcare provider.

Individuals should provide all results obtained with this product to their healthcare

provider for public health reporting and 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 (LVID) Test Code Mapping for SARS-CoV-2 Tests

provided by CDC.

The Bio-SelfTM COVID-19 Antigen Home Test is intended for non-prescription selfuse and/or, as applicable for an adult lay user testing another person aged 2 years

or older in a non-laboratory setting. The Bio-SelfTM COVID-19 Antigen Home Test

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.

Read all instructions carefully before performing the test. Failure to follow the

instructions may result in inaccurate test results.

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.

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. 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.

An anterior nasal swab sample can be self-collected by an individual age 14 years

and older. Children age 2 to 13 years should be tested by an adult.

Ensure that there is sufficient lighting for testing and interpretation.

Do not use on anyone under 2 years of age. Wear a safety mask or other face-covering when collecting anterior nares swab

specimen from a child or another individual. Wash hands thoroughly for at least 20 seconds before and after handling nasal

swab samples.

Immediately use the test kit after opening.

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.

Test components are single-use. Do not re-use.

Keep the test device on a flat surface during testing.

Keep testing kit and kit components away from children and pets before and after

use.

Excess blood or mucus on the swab specimen may interfere with test performance

and may yield a false-positive result.

Inadequate or inappropriate sample collection, storage, and transport can result in

false results. If specimen storage is necessary, swabs can be placed into the

extraction vial for up to three hours. Specimens should not be stored dry. When collecting a nasal swab sample, use only the anterior nasal swab provided

in the kit.

Keep foreign substances and household cleaning products away from the test

during the testing process. Contact with foreign substances and household

cleaning products may result in an incorrect test result.

Use appropriate precautions in the collection, handling, storage, and disposal of

patient samples and used kit contents.

Handle all specimens as though they contain infectious agents.

Do not operate your test outside of storage conditions.

Do not interpret the test result before 15 minutes or after 30 minutes of starting the

test.

Do not use on anyone who is prone to nosebleeds or has had facial or head

injury/surgery in the last 6 months.

Do not use if any of the test kit contents or packaging is damaged.

Do not touch the tip (specimen collection area) of the swab.

Do not use the kit contents beyond the expiration date.

Do not eat, drink, or smoke in the area where the specimens and kit contents

are handled.

Do not interchange kit contents from different lots.

Eye and skin contact with extraction solution should be avoided.

Extraction solution should not be ingested.

For more information on EUAs please visit: https://www.fda.gov/emergencypreparedness-and- response/mcm-legal-regulatory-andpolicyframework/emergency-use-authorization.

For the most up to date information on COVID-19, please visit:

http://www.cdc.gov/COVID19.

Keep testing kit and kit components away from children and pets before and after use.

Avoid contact with your 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 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.

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.

The performance of this test was established based on the evaluation of a limited

number of clinical specimens collected between May 2022 and July 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 SARSCoV-2 and their prevalence, which change over time.

All COVID-19 antigen test negative results are presumptive and confirmation with

a molecular assay may be necessary. If you continue to have symptoms of

COVID-19, and both your first and second tests are negative, you may not have

COVID-19, however you should follow-up with a healthcare provider.

If the test is positive, then proteins from the virus that causes COVID-19 have been

found in the sample and you likely have COVID-19.

These test results are shown as lines of color. Because these lines can be very

faint, users with conditions affecting their vision such as far sightedness,

glaucoma, or color blindness are encouraged to seek assistance to interpret

results accurately (e.g., reading glasses, additional light source, or another

person).

Incorrect test results may occur if a specimen is incorrectly collected or handled.

Store the Bio-SelfTM COVID-19 Antigen Home Test between 2 - 30°C (35.6 - 86°F).

Ensure all kit contents are at room temperature before use. Kit contents are stable until

the expiration date printed on the outer packaging. Do not use beyond the expiration

date. The test card must remain in the sealed pouch until use.

Date of manufacture.

Indicates the date when the medical device was manufactured.

Use-by date.

Indicates the date after which the medical device is not to be used.

Batch code.

Indicates the manufacturer's batch code so that the batch or lot can be identified.

Consult instructions for use.

Indicates the need for the user to consult the instructions for use.

Do not use if package is damaged.

Indicates a medical device that should not be used if the package has been

damaged or opened.

Catalog number.

Indicates the manufacturer's catalog number so that the medical device can be

identified.

Do not re-use.

Indicates a medical device that is intended for one use, or uses on a single

patient during a single procedure.

In vitro diagnostic medical device.

Indicates a medical device that is intended to be used as an in vitro

diagnostic medical device.

Caution.

Indicates the need for the user to consult the instructions for use for important

cautionary information such as warnings and precautions that cannot, for a

variety of reasons, be presented on the medical device itself.

Temperature limit.

Indicates the temperature limits to which the medical device can be safely

exposed.

Manufactured for: BioTeke USA, LLC

900 Brickell Key Boulevard, Suite 2304

Miami, FL 33131

www.bioteke-usa.com | 1-800-240-3944

Version 1.0

May 2023

Limitations

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