® 

FOR OVER-THE-COUNTER AT HOME USE 

Quick Reference Instructions 

For Emergency Use Authorization (EUA) only. 

For in vitro diagnostics use. 

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 SARSCoV-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. 

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

the instructions may result in inaccurate test results. 

For more information on EUAs please visit: 

https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization 

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

www.cdc.gov/COVID19 

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

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

INSTRUCTIONS FOR USE 

For the Healthcare Provider Instructions for Use (IFU), please visit: 

osomhometests.com 

KIT CONTENTS 

® 

Device 

COVID-19 Antigen Home Test

Open When Ready To Test 

15°C 

30°C For use under Emergency Use 

Authorization (EUA) only. 

Single-use test 

device in a foil 

pouch (2) 

Collection tube 

with buffer 

liquid (2) 

Nasal swab 

package (2) 

Quick Reference 

Instructions (1) 

STORAGE AND STABILITY 

Store the test kit at 15-30°C (59-86°F) until use. Ensure all test components 

are at room temperature before use. The OSOM COVID-19 Antigen Home 

Test is stable until the expiration date marked on the outer packaging and 

container. Do not use beyond the expiration date. 

PREPARATION 

1 Read all of the instructions entirely before testing. 

2 Check the test’s expiration date. Do not use an expired test. 

3 Make sure you have all the test kit components. 

4 Wash your hands with soap and water for 30 

seconds or use hand sanitizer. Hands must be 

rinsed thoroughly before testing. Make sure 

hands are dry before starting. 

5 Remove the test device from the foil pouch by tearing along the 

indexed tear-line. Lay the test device on a flat, level surface (table or 

countertop). 

6 Instruct the individual to blow his/her nose to remove excess 

mucus. 

7 Open the nasal swab package. Do not touch the swab tip or lay it 

down on any surface. 

TEST PROCEDURE 

1 Remove the white cap from 

the collection tube and 

place the tube into the hole 

within the box insert. 

WARNING: If any liquid spills, discard test kit and 

re-start test using a new test kit.

2 Remove the swab from the packaging

and be careful not to touch the swab 

tip or lay the swab down on the table. 

Do not touch the swab tip!

3 Swab both nostrils of the individual carefully as shown. Insert 

the entire soft tip of the swab into the 

individual’s first nostril about 1⁄2 to 3⁄4 of 

an inch. 

Firmly brush against the entire 

inner walls of the nostril in a 

complete circle at least 4 times. Do 

not just spin the swab. Remove the 

swab. 

WARNING: Hands must be rinsed 

thoroughly before testing. Do not 

enter the swab any farther if you 

feel any resistance.

Using the SAME SWAB, repeat the 

step above in the OTHER nostril. 

Note: If you are swabbing others, 

please wear a face mask. With 

children, the maximum depth of 

insertion into the nostril may be 

less than 1⁄2 to 3⁄4 of an inch, and 

you may require another adult to 

hold the child’s head while 

swabbing. 

3⁄4” 

deep 

WARNING: False negative results may occur if the nasal 

swab is not properly collected.

4 Remove the collection tube 

from the box insert and insert 

the swab into the collection 

tube containing buffer liquid.

5 Plunge the swab up and down 

while squeezing the swab tip 

repeatedly from the outside of 

the tube for 15 seconds. Be 

careful not to contaminate the 

swab. Avoid spilling or splashing 

of the collection tube contents. 

15 SECONDS 

6 Remove the swab while squeezing the 

sides of the tube to extract the liquid.

WARNING: Failure to squeeze the tube 

can lead to incorrect results due to 

excess buffer in the swab tip.

Firmly cap the collection tube with the 

attached dropper tip. 

7 Invert the collection tube and tap the side of the tube to remove 

any air bubbles from the dropper tip. 

1⁄4 

Do not hold 

more than 1⁄4” 

above 

sample well 

Do not touch 

the sample

well with

dropper tip 

Hold the dropper tip about 1⁄4 of an inch vertically above the 

test device sample well (use both of your hands if needed) and 

slowly squeeze the tube until all of the liquid (at least 5 drops) 

is dispensed into the sample well. 

DO NOT dispense the liquid into the rectangular result 

viewing window. 

8 Wait 15 minutes, then read your test 

results. 

WARNING: Reading before 15 minutes 

or after 30 minutes can lead to false 

results 15 minutes 

DO NOT disturb the test device during this time. 

Inaccurate results can occur if the test is disturbed. 

VIDEO INSTRUCTIONS 

FPO 

Scan this QR code to view video instructions. 

READ AND INTERPRET THE RESULTS 

Table 1: Results Interpretation 

C C 

 T T

COVID-19 Positive (+):

Any visible pink/purple colored Test line 

indicates a positive result.

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

faint visible [color] 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. 

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). 

C 

T 

COVID-19 Negative (-) 

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: 

• 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.

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

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

C C

T T

Invalid

If the Control (C) line is not visible, the test is 

invalid. Re-test with a new swab and new test

device. 

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

below when interpreting test results for COVID-19. 

Table 2: Test Result Interpretation When Repeat Testing is Performed 

Status on First 

Day of Testing 

First Result 

Day 1 

Second Result 

Day 3 

Third Result 

Day 5 Interpretation 

Positive N/A N/A Positive for 

COVID-19 

With 

Symptoms 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 

Without 

Negative Positive N/A Positive for 

COVID-19 

Symptoms 

Negative Negative Positive Positive for 

COVID-19 

Negative Negative Negative Negative 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. 
 

 

INTENDED USE 

The OSOM 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 individuals aged 2 years or older. This test is authorized for individuals with symptoms of 

COVID-19 within the first 5 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 OSOM COVID-19 Antigen Home Test does not differentiate between SARS-CoV or SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally 

detectable in anterior nasal (nares) samples 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 

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 OSOM COVID-19 Antigen Home Test should selfisolate 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 OSOM COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as 

applicable, for an adult lay user testing another aged 2 years or older in a non-laboratory setting. 

The OSOM 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. 

HOW TO USE THIS TEST 

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.

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION 

Read the OSOM COVID-19 Antigen Home Test Package Insert carefully before performing a test. 

Failure to follow directions may produce 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 5 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 ages 2 to 13 years should be tested by an adult.

• If you have had symptoms longer than 5 days you should consider testing at least three times

over five days with at least 48 hours between tests.

• 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 device should be used within 30 minutes.

• 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.

Chemical Name Hazards (GHS Code) 

for each ingredient Concentrations 

Triton X-100/9002-93-1 

H302, Harmful if swallowed 

H315, Skin irritation 

H318, Serious eye damage 

0.1% 

Lauryldimethylamine oxide 

(LDAO)/1643-20-5 

H302, Harmful if swallowed 

H315, Skin irritation 

H318, Serious eye damage 

H319, Serious eye irratation 

0.5% 

LIMITATIONS 

• 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 June 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

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.

• Hand soap liquid gel may produce false positive results.

FREQUENTLY ASKED QUESTIONS 

Q: WHAT ARE THE KNOWN POTENTIAL RISKS AND BENEFITS OF THIS TEST? 

A: Potential risks include: 

• Possible discomfort during sample collection.

• Possible incorrect test results (see Warnings and Read and Interpret the Results sections for

more information).

Potential benefits include:

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

informed decisions about your care.

• The results of this test may help limit the 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

Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST? 

A: 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 OSOM 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. 

Q: HOW ACCURATE IS THIS TEST? 

A: 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 osomhometests.com. 

Q: WHAT IF I HAVE A POSITIVE TEST RESULT? 

A: 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. 

Q: WHAT IF I HAVE A NEGATIVE TEST RESULT? 

A: 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. 

Q: WHAT DOES AN INVALID TEST RESULT MEAN? 

A: 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. 

Index of Symbols 

Contains sufficient for <n> Humidity limitation Use-by date tests 

Consult instructions for In vitro diagnostic

medical device Catalog number use 

Temperature limit Batch code Do not reuse 

SUPPORT 

If you have questions regarding the use of this product, or if you want to report a problem with the test, 

please contact SEKISUI Diagnostics Technical Services at (800) 491-6220 or 

techservices@sekisuidiagnostics.com. 

Additional information is also available for you and your healthcare provider at osomhometests.com. 

The Quick Reference Instructions, Fact Sheet for Health Care Providers and Health Care Provider 

Instructions for Use are also available at osomhometests.com. The OSOM COVID-19 Antigen Home 

Test Letter of Authorization, authorized Fact Sheet, and authorized labeling are available on the FDA 

website. 

Manufactured by: Distributed by: 

ANP Technologies, Inc. SEKISUI Diagnostics, LLC 

824 Interchange Blvd. 6659 Top Gun Street 

Newark, DE 19711, USA San Diego, CA 92121 USA 

CONTACT & TECHNICAL SUPPORT 

US +1 800-491-6220 

(Monday to Friday – 8:00 AM to 5:00 PM ET) 

techservices@sekisuidiagnostics.com (24/7) 

© 2023 SEKISUI Diagnostics, LLC – All rights reserved. 

OSOM® is a registered trademark of SEKISUI Diagnostics, LLC. 

3456-6-df 

06/2023 
COVID-19 Antigen 

Home Test TESTS

2 

For use under Emergency Use 

Authorization (EUA) only.

30°C

15°C

® COVID-19 Antigen Home Test 

Device 

Open When Ready To Test

Manufactured by: 

ANP Technologies, Inc. 

Newark, DE 19711, USA

Distributed by:

SEKISUI Diagnostics, LLC

San Diego, CA 92121 USA

Single-use test

device in a foil pouch 

Collection tube

with buffer liquid

Nasal swab

package

Quick Reference

Instructions

CONTENTS

3459-5-df

Distributed by:

SEKISUI Diagnostics, LLC

6659 Top Gun Street

San Diego, CA 92121 USA

30°C

15°C 86°F

59°F

1067-2

TUBE HOLDERS

For an Emergency Use Authorization (EUA) only

OSOM COVID-19 Antigen Home Test is intended for the qualitive detection of The 

SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.

This test does NOT determine if you had COVID-19 in the past or if you have 

immunity. 

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.

If you test positive for COVID-19 please contact your doctor/primary care physician or 

your local health authority immediately and adhere to the local guidelines regarding 

self-isolation.

For home testing (ages 2 and up).

COVID-19 Antigen 

Home Test

Scan QR Code to view video instructions. fter opening a Use within 30 minutes 

the foil pouch. 

f the extraction liquid o void contact A

ube with skin and eyes. T in 

Item necessary to use the test but 

not provided in the test kit is a timer.

In the USA, this product has not been FDA cleared or approved, but has been authorized 

by FDA under Emergency Use Authorization (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.

The OSOM COVID-19 Antigen Home Test is a lateral flow immunoassay that uses 

antibodies to detect nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal 

swabs. The test is authorized for individuals with symptoms of COVID-19 within the first 

five (5) days of symptom onset, when tested twice over three days with at least 48 hours 

between tests or individuals without symptoms or other epidemiological reasons to 

suspect COVID-19, when tested at least three (3) times over five (5) days and at least 48 

hours between tests. 

please refer to For more information on expiration dating for COVID-19 antigen tests, 

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

sekisuidiagnostics.com A B C D

Manufactured by:

ANP Technologies, Inc. 

824 Interchange Blvd.

Newark, DE 19711, USA

COVID-19 Antigen Home Test

Home Test COVID-19 Antigen 

2 

TESTS

Rapid Results in 15 Minutes

Spike

KIT CONTENTS:

2 x Individually pouched Test Devices

2 x Tubes containing 300 μl of buffer liquid

2 x Sterile Swabs

4 x Tube holders (backside of carton)

1 x Quick Reference Instructions

COVID-19 Antigen 

Home Test ®

111132 /

1 438/

8532 / 111132 / FPO (01)12345678901234

(17)123456

(10)1234567890

171512

2126

DEVELOPMENT LABEL 06/04/2023
For an Emergency Use Authorization (EUA) only

OSOM COVID-19 Antigen Home Test is intended for the The 

qualitive detection of SARS-CoV-2 nucleocapsid protein antigen in 

anterior nasal (nares) swab samples.

This test does NOT determine if you had COVID-19 in the past or if 

you have immunity. 

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.

If you test positive for COVID-19 please contact your doctor/primary 

care physician or your local health authority immediately and 

adhere to the local guidelines regarding self-isolation.

For home testing (ages 2 and up).

COVID-19 Antigen 

Home Test

Scan QR Code to view video instructions. fter opening the foil pouch. a Use within 30 minutes 

ube with skin and eyes. T f the extraction liquid in o void contact A

Item necessary to use the test but not provided in the test kit 

is a timer.

In the USA, this product has not been FDA cleared or approved, but has been 

authorized by FDA under Emergency Use Authorization (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.

The OSOM COVID-19 Antigen Home Test is a lateral flow immunoassay that 

uses antibodies to detect nucleocapsid protein antigen from SARS-CoV-2 in 

anterior nasal swabs. The test is authorized for individuals with symptoms of 

COVID-19 within the first five (5) days of symptom onset, when tested twice 

over three days with at least 48 hours between tests or individuals without 

symptoms or other epidemiological reasons to suspect COVID-19, when 

tested at least three (3) times over five (5) days and at least 48 hours between 

tests. 

For more information on expiration dating for COVID-19 antigen tests, 

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

sekisuidiagnostics.com

TESTS

40

Spike

COVID-19 Antigen 

Home Test

®

TESTS

40

Rapid Results in 15 Minutes

Spike

CONTENTS:

20 - Test Kits, each containing

 2 - Individually pouched Test Devices

 2 - Tubes containing 300 μl of buffer liquid

 2 - Sterile Swabs

 1 - Tube holder

 1 - Quick Reference Instructions (QRI)

COVID-19 Antigen 

Home Test

®

COVID-19 Antigen Home Test

Distributed by:SEKISUI Diagnostics, LLC6659 Top Gun StreetSan Diego, CA 92121 USA

For use under Emergency Use 

Authorization (EUA) only.

30°C

15°C

® COVID-19 Antigen Home Test 

Device 

Open When Ready To Test

Manufactured by: ANP Technologies, Inc. Newark, DE 19711, USA

Distributed by:SEKISUI Diagnostics, LLCSan Diego, CA 92121 USA

Single-use test

device in a foil pouch 

Collection tube

with buffer liquid

Nasal swab

package

Quick Reference

Instructions

CONTENTS

30°C

86°F 15°C

59°F

1067-40

Manufactured by:ANP Technologies, Inc. 824 Interchange Blvd.Newark, DE 19711, USA

Home Test COVID-19 Antigen 

3462-5-df

212

6

212

6

FPO (01)12345678901234 (17)123456

(10)1234567890

2019-04-30

17151212

DEVELOPMENT LABEL 06/04/2023