Please wash and dry your 

hands thoroughly before the 

test.

Read the Instructions for use 

carefully.

Insert the swab and soak in the liquid for at 

least 15 seconds, stir the swab several 

times, and squeeze the tube walls onto the 

swab tip 3 times.

8

1

2

Tap the sample tube vertically several 

times on the table. Open the larger cap on 

the sample tube.

7

Pinch tube walls while removing swab to 

squeeze excess liquid from tip.

Close the sample tube with the larger tube cap.

9

10

5

COMPONENTS

TEST STEPS

Timer 

(not included) 

Sample 

Tube

Disposable 

Sterile Swab

SARS-CoV-2 

Antigen Test 

Cassette

SPECIMEN COLLECTION

HOW TO USE THIS TEST

Children between 2-13 years of age should be tested by 

an adult.

Open the small cap at the front 

end of the sample tube, and 

place exactly 4 drops into the 

sample well (S) of the test 

cassette.

12

14

11

Open the foil pouch and place the 

test cassette on a flat surface. 

Start a timer and read the result at 15 

minutes. Do not read test before 15 minutes, 

even if the Control (C) line appears sooner. 

Do not read after 30 minutes.

13

Throw away all used test kit 

components in the trash.

Take the swab out of the package 

and do not touch the sampling end.

4

3

Confirm the liquid level is at or 

above Line 1 in the sample tube. Then 

proceed to collecting the nasal swab 

sample.

Beijing Hotgen Biotech Co.,Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, 

Daxing District, Beijing, 102600, P.R. China.

For self-testing use 

SARS-CoV-2 Antigen Test Cassette

2 2

9th Building,

Beijing Hotgen Biotech Co.,Ltd.

 No. 9 Tianfu Street, Biomedical Base, 

Daxing District, Beijing, 102600, P.R. China.

For self-testing use 

SARS-CoV-2 Antigen Test Cassette

2 2

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 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.

6

Repeat sampling with the same 

swab in the other nostril.

For Emergency Use Authorization (EUA) Only.

In vitro diagnostic use only.

COVID-19 Negative (-): As shown in Fig. 2, if the Control (C) 

line is visible, but the Test (T) line is not visible, the test is 

negative. 

Invalid: As shown in Fig. 3, if the Control (C) line is not 

visible, the test is invalid. Re-test with a new swab and 

new test device.

COVID-19 Positive (+): As shown in Fig. 1, if both the Control 

(C) line and the Test (T) line are visible, the test is positive.

Any faint visible red/purple test (T) line with the control line 

(C) should be read as positive.

TEST INTERPRETATION

Positive N/A N/A Positive for COVID-19

Negative Positive N/A Positive for COVID-19

Negative Negative N/A Negative for COVID-19

Positive N/A N/A Positive for COVID-19

Negative Positive N/A Positive for COVID-19

Negative Negative Positive Positive for COVID-19

Negative Negative Negative Negative for COVID-19

Without Symptoms

With Symptoms 

Status on First Day 

of Testing

First Result 

Day 1

Second Result 

Day 3

Third Result 

Day 5

Interpretation

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.

Carefully insert the swab 1/2 to 3/4 

of an inch into the nostril. Under 

moderate pressure, swab the nostril 

at least 5 times for at least 15 

seconds total.

TM

COMPONENTS

TEST STEPS

SPECIMEN COLLECTION

HOW TO USE THIS TEST

TEST INTERPRETATION

8

1

2 7

9

10

5 11

13

3

6

Note: Check kit components and 

confirm test is not expired prior to use. 

Use within 2 hours after opening the 

foil pouch (step 11).

For the most current expiration dates 

of this test, please refer to:

http://www.fda.gov/covid-test

Note: A false negative or false positive 

result may occur if the test result is read 

before 15 minutes or after 30 minutes.

Note: False negative or invalid results may occur if too 

little sample is added. Do not touch or move the test 

cassette during this time.

Note: Do not touch the swab tip with 

your fingers.

Note: If the liquid level is below Line 

1 in the sample tube, DO NOT 

proceed with the test. The test result 

will not be accurate. If the sample 

tube liquid level is below Line 1, use 

a new kit.

Line 1

Note: Failure to swab properly may 

cause false negative results.

Squeeze

4 drops

Note: For young children, the swab 

may not need to be inserted so far. 

Stop pushing the swab in if you feel 

any kind of resistance.

COVID-19 Antigen Home Test

Instructions For Use 

Note: 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 COVI0-19 

was detected in your sample and it is very likely you have COVI0-19 

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). 

Note: To increase the chance that the negative result for 

COVID-19 is accurate, you should: · Test again in 48 hours if the individual has symptoms on the 

first day of testing. · Test 2 more times at least 48 hours apart if the individual 

does not have symptoms on the first day of testing. A negative test result indicates that the virus that causes COVI0-19 

was not detected in the sample. A negative result does not rule out 

COVI0-19. There is a higher chance of false negative results with 

antigen tests compared to laboratory-based tests such as PCR 

tests. If the test is negative but COVI0-19-like symptoms, e.g., fever, 

cough, and/or shortness of breath continue, follow up testing for 

SARS-CoV-2 with a molecular test or testing for other respiratory 

disease should be considered. If applicable, seek follow up care 

with the primary health care provider. 

For use with anterior nasal swab specimens. 

Without Symptoms

With Symptoms 

Fig.1 

Fig.2 

Fig.3 

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.

Note: Locate sample well on the 

test cassette. It is marked with the 

letter S and an image of a drop.
The HotgenTM COVID-19 Antigen Home Test is a lateral flow immunoassay 

device 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 

individual 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 HotgenTM 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 

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

definite cause of disease. Individuals who test positive with the HotgenTM 

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-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 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 (LIVD) Test Code Mapping for 

SARS-CoV-2 Tests provided by CDC.

The HotgenTM COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another 

person 2 years of age or older in a non-laboratory setting. 

The HotgenTM COVID-19 Antigen Home Test is only for in vitro diagnostic 

use under the Food and Drug Administration’s Emergency Use Authorization. The product has not been FDA cleared or approved.

 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. 

· 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. 

· Do not touch the swab tip. 

· Once opened, the test cassette should be used within 2 hours. 

· 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. 

· 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.

· For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-andresponse/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 

· 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 February 2022 and 

June 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. 

· This test is read visually and has not been validated for use by those with 

impaired vision or color-impaired vision. 

· 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

WARNINGS, PRECAUTIONS AND SAFETY INFORMATION

FREQUENTLY ASKED QUESTIONS (FAQ)

LIMITATIONS

STORAGE AND OPERATION CONDITIONS

INDEX OF SYMBOLS

Store HotgenTM COVID-19 Antigen Home Test in a dry place between 36-86°F

(2-30°C). Ensure all test components are at room temperature 65-86°F

(18-30°C) before use. It is stable before the expiration date marked on the 

packaging.

Beijing Hotgen Biotech Co., Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, 

Beijing, 102600, P.R. China.

Tel:+1(800)966-2919 Email:cs@hotgen.info Website: www.hotgen.info

What are the known and potential risk and benefits for the test?

Potential risks include:

· Possible discomfort during sample collection.

· Possible incorrect test result (see Warnings and Result Interpretation

sections for more information).

Potential benefits include:

· 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-andresponse/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization 

What do I have to pay attention to in order to get the most exact test result possible?

Always follow the instructions for use exactly. Perform the test immediately after 

collecting the sample. Put the drops from the sample tube only into the designated 

well of the test cassette. Dispense four drops from the sample tube. Too many or too 

few drops can lead to an incorrect or invalid test result.

How does the test work?

The N-protein of the SARS-CoV-2 virus reacts with the coating of the test line and 

leads to a color change, i.e. a red line appears. If the sample does not contain 

SARS-CoV-2 virus , no red test line (T) appears.

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 

HotgenTM 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 www.hotgen.info. 

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 selfisolate 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.

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

handled.

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. 

The test strip is very discolored. Why is this or what am I doing wrong?

The reason for a clearly visible discoloration of the test strip is that too large a quantity 

of drops has been dispensed from the test tube into the test cassette well. The 

indicator strip can only hold a limited amount of liquid. If the control line does not 

appear or the test strip is severely discolored, please repeat the test with a new test 

kit according to the instructions for use.

What should I do if I did the test but don't see a control line?

In this case the test result is to be considered invalid. This can possibly be caused by 

incorrect test operation. Please repeat the test with a new test kit according to the 

instructions for use. If you have any further invalid test results, contact your doctor or 

a COVID-19 test center.

Can this test cassette be reused or used by more than one person?

This test cassette is for single use and cannot be reused or used by more than one 

person.

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.

Use-by date

Contents 

sufficient for

 <n> tests

Date of 

manufacture

In vitro 

diagnostic

medical device

Batch code

Temperature 

limit

Keep away from 

sunlight

Consult 

instructions 

for use

Catalogue 

number

Manufacturer Do not re-use

Keep dry

Warnings

Do not use if the 

packaging is 

damaged

Over the 

counter

INTENDED USE

Chemical Name Subcomponent GHS Code for each Ingredient Concentrations

KV-300 

H316, Skin 

Sensitization

H316, Skin 

Sensitization

0.00255%

0.00081%

5-Chloro-2-Methyl-4-

Isothiazolin-3-One

2-Methyl-4-

Isothiazolin-3-One

KV-300 

APPROVAL DATE AND REVISION DATE OF THE INSTRUCTION

Approved: April, 2023;

Version number: V.2023-04.13[Eng.]
TM

6936700405200

FDA Emergency 

Use Authorization

1 Test

COVID-19 Antigen Home Test

At-home Use Results in 15 Mins

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Beijing Hotgen Biotech Co., Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing, 102600, P.R. China.

Tel:+1(800)966-2919 Email:cs@hotgen.info Website: www.hotgen.info

Made in China

WARNINGS

         	    	





	



­	

­

	

CONTENTS

HOW THIS TEST WORKS

 ­  

	

		

 ­

					

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For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit 

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

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COVID-19 Antigen Home Test

HGCG134S0102

Beijing Hotgen Biotech Co., Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing, 102600, P.R. China.

cs@hotgen.info Website: www.hotgen.info : 966-2919 Email ) 800 (+1 : Tel

Made in China

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At-home Use Results in 15 Mins

2 Tests

6 936700 403916

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TM

WARNINGS

         	    	





	



­	

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CONTENTS

HOW THIS TEST WORKS

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	­

		­

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For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit 

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

xxxxxxxxxx

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HGCG134S0105 

FDA Emergency 

Use Authorization

TM 5 Tests

6 936700 405217

COVID-19 Antigen Home Test

At-home Use Results in 15 Mins

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·				

	
				 

			

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Beijing Hotgen Biotech Co., Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing, 102600, P.R. China.

cs@hotgen.info Website: www.hotgen.info : 966-2919 Email ) 800 (+1 : Tel

Made in China

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WARNINGS

         	    	





	



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CONTENTS

HOW THIS TEST WORKS

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For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit 

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

xxxxxxxxxx

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HGCG134S0110 

FDA Emergency 

Use Authorization

TM 10 Tests

6 936700 405224

COVID-19 Antigen Home Test

At-home Use Results in 15 Mins

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CONTENTS

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Beijing Hotgen Biotech Co., Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing, 102600, P.R. China.

cs@hotgen.info Website: www.hotgen.info : 966-2919 Email ) 800 (+1 : Tel

Made in China

For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit 

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

xxxxxxxxxx

xxxxxx

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20 Tests

HGCG134S0120

TM

FDA Emergency 

Use Authorization

Beijing Hotgen Biotech Co., Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing, 102600, P.R. China.

Tel:+1(800)966-2919 Email:cs@hotgen.info Website: www.hotgen.info

Made in China

For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit 

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

COVID-19 Antigen Home Test

At-home Use Results in 15 Mins

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20 Tests

6 936700 405231

COVID-19 Antigen Home Test

Results in 15 Mins At-home Use

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40 Tests

HGCG134S0140

FDA Emergency 

Use Authorization

40 Tests TM

TM

FDA Emergency 

Use Authorization

6 936700 405248

COVID-19 Antigen Home Test

At-home Use Results in 15 Mins

Beijing Hotgen Biotech Co., Ltd.

9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing, 102600, P.R. China.

Tel:+1(800)966-2919 Email:cs@hotgen.info Website: www.hotgen.info

Made in China

For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit 

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

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