Where can I go for updates and more information?

The most up-to-date information on COVID-19 is available at the CDC 

general webpage: https://www.cdc.gov/COVID19. In addition, please also

contact your healthcare provider with any questions/concerns.

What are the known and potential risks and benefits

of the test? 

Potential risks include:

Possible discomfort or other complications that can happen during 

sample collection. 

Possible incorrect test result (see below for more information). 

Potential benefits include:

For more information on EUAs go here: 

https://www.fda.gov/emergency-preparedness-and-respo

nse/mcm-legal-regulatory-and-policy-framework/emergen

cy-use-authorization

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.

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 Swab-N-Go Home Test COVID-19 Ag, 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.

What are the differences between antigen tests and

other COVID-19 tests?

38 Industrial Way Ste.1, Eatontown, NJ, 07724 USA

Tel: +(1) 732-918-0770 / Toll Free: +(1) 800-722-7505

Fax: +(1) 732-918-0618 / sales@immunostics.com

www.immunostics.com

Immunostics, Inc.

Distributed by

43, Geodudanji 1-gil, Dongnae-myeon,

Chuncheon-si, Gang-won-do 24398, Korea

Tel: +82-33-243-1400 Fax: +82-33-243-9373

www.boditech.co.kr

Boditech Med Inc.

Manufactured by

Instructions for Use

Swab-N-go Home Test COVID-19 Ag is for in vitro diagnostic use 

only under the FDA's Emergency Use Authorization. This product 

has not been FDA cleared or approved.

Please read all the instructions before performing the test.

For use with anterior nasal swab specimens. 

Intended use

The Swab-N-Go Home Test COVID-19 Ag is a lateral flow immunoassay 

intended for the qualitative detection of nucleocapsid protein antigens 

from SARS-CoV-2.

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 two 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 Swab-N-Go Home Test COVID-19 Ag 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 

co-infection with other viruses and the agent detected may not be the 

definitive cause of disease. Individuals who test positive with the 

Swab-N-Go Home Test COVID-19 Ag 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-19 like 

symptoms of fever, cough and/or shortness of breath may still have 

SARS-CoV-2 infection and should seek follow up care with their 

physician or healthcare provider.

Individuals should provide all results obtained with this product to their 

healthcare provider for public health reporting and to receive 

appropriate health 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 (LIVD) Test Code 

Mapping for SARS-CoV-2 Tests provided by the CDC.

The Swab-N-Go Home Test COVID-19 Ag is intended for non-prescription

self-use and/or, as applicable for an adult lay user testing another 

person aged two years or older in a non-laboratory setting.

The Swab-N-Go Home Test COVID-19 Ag 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.

Swab-N-Go Home Test

COVID-19 Ag

Document No.: INS-SH-US

Revision Date: July, 2023 (Rev.01)

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 March 

2022 to August 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 SARS-CoV-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.

Extract the swab in the extraction buffer tube right after collecting 

the nasal swab sample.

Swab samples should be tested immediately after extraction in the 

extraction tube. If immediate testing is not possible, the nozzle-fitted 

extraction tube may be stored for up to 1 hour at room temperature 

around 15–30 °C (59–86 °F). Do not freeze the extracted sample.

Limitations

Frequently Asked Questions (FAQ)

Warnings, Precautions, and Safety Information

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 for 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.

Do not use on anyone under 2 years of age.

Wear a safety mask or other face-covering when collecting a specimen 

from a child or another individual.

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

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

Do not use kit past its expiration date. For information about current 

expiration dates for at-home OTC COVID-19 diagnostic tests, visit 

“At-Home OTC COVID-19 Diagnostic Tests”: 

https://www.fda.gov/covid-tests

Do not touch the swab tip.

Once opened, the test cartridge should be used within 15 minutes.

Do not read test results before 15 minutes or after 20 minutes. Results 

read before 15 minutes or after 20 minutes may lead to a false positive, 

false negative, or invalid result.

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.

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.

How to Use This Test

For more information on EUAs please visit: 

https://www.fda.gov/emergency-preparedness-and-response/mc

m-legal-regulatory-and-policy-framework/emergency-use-author

ization 

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

www.cdc.gov/COVID19 

If irritation persists, seek medical advice: 

https://www.poisonhelp.org or 1-800-222-1222. 

H300, Fatal if swallowed

H310, Fatal in contact with skin

H400, Very toxic to aquatic life

H410, Very toxic to aquatic life with 

 long lasting effects

GHS Code 

0.05%

Concentration

Sodium azide

Chemical Name

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.

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.

How accurate is the 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.fda.gov/covid-tests.

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.

Contains sufficient for <n> tests

Batch code

Do not re-use

Caution

Catalogue number

Manufacturer

Date of manufacture

Temperature limit

Symbol glossary

(Explanation of symbols used in Immunostics' device labeling)

Consult instructions for use

Use-by date

In vitro diagnostic medical device
This product has not been FDA-cleared or approved but has been 

authorized by FDA under an Emergency Use Authorization (EUA).

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.5C § 360bbb-3(b)1), unless the 

declaration is terminated, or authorization is revoked sooner.

3)

This test is intended to be used as an aid to the clinical diagnosis of a 

current COVID-19 infection. Do not use this test result as the only 

guide to manage your illness.

1)

2) This product has been authorized for the detection of proteins from 

SARS-CoV-2 and, not for any other virus or pathogens.

Please note:

Swab-N-Go Home Test

COVID-19 Ag

RAPIDCHECK mobile application

The RAPIDCHECK app allows you to save your Swab-N-Go Home Test 

COVID-19 Ag results and report the test result(s) at MakeMyTestCount.Org

Compatible smart phones: iPhones (iOS 14.2 or later), and 

Android Phones (Android 10 or later). For a list of compatible

smartphone OS systems, visit www.immunostics.com/app-1

Download the app by scanning the QR code.

Open the App.

Answer a few questions in the App.

Follow step-by-step instructions for 

performing your test.

Visually read and interpret your test result.

Report your test result(s) at MakeMyTestCount.Org as directed by 

the app. Alternatively, for digital instructions go to 

https://immunostics.safekey.tools/

Make sure you have enough time to complete the entire test 

process. It takes approximately 20 minutes once you begin.

Wash your hands or use hand sanitizer.

Make sure your hands are dry before 

you start testing.

Open the kit and remove one each of the following items.

Check items for damage.

Note: Do not open individual components until instructed to do so.

1 Gather and check your supplies

One swab

One test 

cartridge pouch One nozzle

One extraction

buffer tube

00:00 00:00

Step-by-step instructions

Have a watch or timer ready 

(not included in the kit).

Check the expiration date (Use-by 

date) on the cartridge pouch.

Swab-N-Go Home Test

COVID-19 Ag

1 36 F

86 F

2 C

30 C

Swab-N-Go Home Test

COVID-19 Ag

1 36 F

86 F

2 C

30 C

Expiration date (Use-by date)

YYYY.MM.DD

2 Open the extraction buffer tube

Open the extraction buffer tube by 

removing its foil seal.

Put the unsealed tube in the tube holder 

Tube provided in the box.

holder

4 Swab both nostrils using the same swab

Gently insert the entire absorbent tip of the 

swab no more than 1⁄2 to 3⁄4 of an inch into 

your nostril.

Note: For children, maximum depth of 

insertion into the nostril may be less than 

1⁄2 to 3⁄4 inch.

For very young children and some patients, 

you may need another person to hold their 

heads while swabbing.

Remove the swab from its wrapper.

Do not touch the tip of the swab. 

Note: If you are swabbing others, please wear a face mask and gloves.

3 Remove the swab from its wrapper 

 ×6

Note: Failure to swab properly may 

cause false negative results.

Firmly and slowly swab in a complete circle 

against the inside of the nostril at least 6 

times.

Repeat the same sample collection 

procedure for the other nostril using the 

same swab.

Second

nostril

Same swab

First 

nostril ×6

6 Add sample to the test cartridge

Note: Swab samples should be tested immediately after processing in 

the extraction tube.

7 Wait 15 minutes

Start a timer for 15 minutes immediately 

after adding the sample to the test cartridge.

Leave the test cartridge on a flat surface 

until the timer goes off.

Read test result immediately when timer 

goes off.

15

Minutes

Remove the test cartridge from its 

pouch and place it on a flat, clean, 

and dry surface. 

Slowly squeeze 4 drops of the 

sample into the 'sample well' of the 

test cartridge.

Note: Test result may be false negative

or invalid if less than 4 drops of the 

sample are added to the sample well.

Do not add the sample to the 'test 

result window' of the test cartridge.

4drops

Sample 

well

5 Transfer swab to the extraction buffer tube

Note: Transfer the swab to the extraction tube immediately after 

collecting the nasal sample. 

Remove the swab while 

squeezing the sides of the 

tube to press out as much 

liquid as possible from the 

swab.

Swirl the swab 5 times in the 

tube liquid, while making sure 

the swab tip remains 

completely immersed in the 

liquid.

WARNING: False results may 

occur if the swab is swirled less 

than 5 times.

Snap-fit the nozzle onto the 

extraction tube.

Remove the tube from the 

tube holder.

Immediately place the swab 

into the extraction tube.

Note: If you do not squeeze the 

swab, test result may be false 

negative. 

Dispose of swab in a trash bin.

 ×5

Dispose 

the swab

Squeeze while 

removing the swab

Fit the

nozzle

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. 

· 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. 

COVID-19 Negative (-)

9-B Negative result

9-C Invalid result

10 Dispose of used test kit materials

If the test result is invalid, you need to retest with a new test kit after 

collecting a fresh sample.

If the test result is still invalid upon retesting, contact Immunostics Inc. 

at 1-732-918-0770.

After interpreting the test results, 

dispose of all used test kit materials.

Next steps: 

If the control (C) line is not visible, the 

test is invalid. Re-test with a new swab 

and new test device.

Invalid

OR

8 Read the test result

Read the test result in a well-lit area.

Look for red lines in the area next 

to the 'C' and 'T' in the test result 

window to read your result.

Note: A false negative or false positive result may occur if the test 

result is read before 15 minutes or after 30 minutes. 

Test result window

9 Interpret the test result

Note: Test result is positive even if the line next to ‘T’ is faint.

Test result may be positive, negative, or invalid.

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

line are visible, the test is positive. Any 

faint visible red test (T) line with the 

control line (C) should be read as 

positive.

You do not need to perform repeat 

testing if you have a positive result 

at any time.

COVID-19 Positive (+)

9-A Positive result

OR OR OR

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.

With

Symptoms

Without

Symptoms

Status on First

Day of Testing

Positive

Negative

Positive

Negative

Negative

Negative

Negative

First Result

Day 1

N/A

Positive

N/A

Positive

Negative

Negative

Negative

Second

Result Day 3

Third Result

Day 5

N/A

N/A

N/A

N/A

Positive

N/A

Negative

Positive for 

COVID-19

Positive for 

COVID-19

Positive for 

COVID-19

Positive for 

COVID-19

Positive for 

COVID-19

Negative for 

COVID-19

Interpretation

Negative for 

COVID-19

Document No.: INS-SH-US

Revision Date: July, 2023 (Rev.01)

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). 

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

Please read all the instructions before performing the test.

For use with anterior nasal swab specimens. 

For Diagnostic (IVD) Use Only. In Vitro

Do not perform the test in conditions outside of recommended 

room temperatures (15– 30°C /59–86°F).
Swab-N-Go Home Test COVID-19 Ag cartridge box 

PS-1830 Rev01 06/30/2023

Tube Holder

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use

38 Industrial Way Ste.1, Eatontown, NJ, 07724 USA

Tel: +(1) 732-918-0770 / Toll Free: +(1) 800-722-7505

Fax: +(1) 732-918-0618 / sales@immunostics.com 

www.immunostics.com

Immunostics, Inc.

Distributed by

43, Geodudanji 1-gil, Dongnae-myeon,

Chuncheon-si, Gang-won-do 24398, Korea

Tel: +82-33-243-1400 Fax: +82-33-243-9373

www.boditech.co.kr

Boditech Med Inc.

Manufactured by Using the RAPIDCHECK mobile application:

Please follow the in-app self-paced, step-by-step instructions.

1 Download and open the App.

2 Answer a few questions in the App.

Follow step-by-step instructions for performing your test.

4

5

3

Scan QR code with phone 

camera to download the App.

For a list of compatible smartphone 

OS systems, visit 

www.immunostics.com/app-1

In the USA, 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 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.

■ Do not use on anyone under 2 years of age.

■ For ages 2 to 13 years, anterior nares specimens must be collected by an adult.

Swab-N-Go Home Test

COVID-19 Ag

PS-1830 Rev01 06/05/2023

PS-1830 Rev01 06/30/2023

Visually read and interpret your test result.

Report your test result.

2

TESTS

Home Test Swab-N-Go

COVID-19 Ag

8 806133 080849

36 F

86 F

2 C

30 C

2

Required for using the mobile application: Access to smartphone, internet,and email account.

(You may also use the printed instructions included in the box.)

For symbol glossary, refer to the printed instructions 

included in the box.

Store at 36°F - 86°F 

(2°C - 30°C).

Open Here

Determining a negative result requires multiple tests. You may need to purchase 

additional tests to perform serial (repeat) testing. This test is more likely to give you 

a false negative result when you have COVID-19 than a lab-based molecular test.

CFPT-17

For the most current expiration dates of this test, 

please refer to: https://www.fda.gov/covid-tests

For Emergency Use Authorization (EUA) only

Home Test Swab-N-Go

COVID-19 Ag

This box contains two tests and a Quick Reference Instructions (QRI). ■

■ If you have symptoms of COVID-19, you will need to use the test at least twice over three days 

 with at least 48 hours between tests.

■ If you do not have any symptoms of COVID-19, you will need to use the test at least three times 

 over five days, with at least 48 hours between tests.

Purchase additional tests to perform further serial (repeat) testing. ■ 

This test is more likely to give you a false negative result when you have ■ 

 COVID-19 than a lab-based molecular test.

MIN 15 Test result in

Contents:

Collect nasal swab

from both nostrils

Swirl, squeeze and 

remove the swab

Add sample Apply nozzle

to the cartridge

See the result 

after 15 minutes

15

MIN

2 Swabs

2 Test cartridges

2 Extraction tubes

2 Nozzles

1 Quick Reference Instructions

 Home Test COVID-19 Ag offers rapid, easy-to-interpret Swab-N-Go

results at home with a simple procedure without any training.

Have a watch or timer ready 

(not included in the kit)

 diagnostic use in vitro For 

2

TESTS

SHSEA03 2024.08.15

(01)08806133080849

(17)240815

(10)SHSEA03 SAMPLE

SAMPLE