IMMUVIEW® COVID-19 Antigen Home Test

Instructions For Use

•	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. 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. For Emergency Use Authorization (EUA) Only. | For in vitro diagnostic use.

R0182CHT

Scan to access product website

BEFORE OPENING THE TEST If you are testing more than one person, always clean the test space and wash your hands 

between each test.

You will need (not included in kit): 

• Watch or timer

• Tissues

• Soap and water or hand sanitizer

• Mirror (optional) 

Clean and dry a flat, 

well-lit surface, such 

as a table or counter 

top. Blow your nose and 

discard tissue.

Wash your hands 

thoroughly and DRY them.

1 2

3 4

PREPARE FOR TESTING Do not use the kit if the items are damaged, missing, or expired. Use buffer and cassette within 30 minutes 

of opening pouches. For 2, 5 and 20 test kits, do not throw the kit box away until all tests are used up.

5

6

• Remove all items needed for 1 test.

• Check that the seal is still intact in all items. Check the expiration dating 

of the kit. For current information on the expiration dating of the product 

please visit: https://www.fda.gov/medical-devices/coronavirus-covid19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list

Open the pouch labeled “Buffer and Nozzle”. 

“Buffer and Nozzle” pouch Cassette pouch Swab

The lmmuView® 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 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 lmmuView® 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. The agent detected may not be the definite 

cause of disease. Individuals who test positive with the lmmuView®

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 ImmuView® COVID-19 Antigen Home Test is intended for nonprescription 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 

ImmuView® COVID-19 Antigen Home Test is only for use under the Food 

and Drug Administration’s Emergency Use Authorization. This product 

has not been FDA cleared or approved.

WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF 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 the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19. 

For more information on EUAs go here: https://www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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 ImmuView® 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://immuviewathome.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 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 

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.

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• 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. 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.

• 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.

• Do not touch the swab tip.

• Once opened, the test card 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. • For more information on EUAs please visit: https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policy-framework/ 

emergency-use-authorization. • For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19. • For detailed instructions, please visit: https://immuviewathome.com. • Keep testing kit and kit components away from children and pets before and after use. 

Avoid contact with your skin, eyes, and mouth. Do not ingest any kit components. The 

reagent solution contains harmful chemicals (see table below). If the solution contacts 

your skin, eyes, or mouth, flush with large amounts of water. If irritation persists, seek 

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

• This test detects both viable (live) and nonviable SARS-CoV-2. Test performance 

depends on the amount of virus (antigens) in the sample and may or may not correlate 

with viral culture results performed on the same sample.

• 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 and 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 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.

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

vision or color-impaired vision.

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

Please visit https://immuviewathome.com to obtain the complete instructions for use and fact 

sheet for healthcare providers.

1. In a dry place, at 35°F-86°F (2°C-30°C).

2. Keep away from direct sunlight and do not store it in a freezer. 

3. If you stored the kit in an area colder than 59°F (15°C), leave it at room temperature for 

30 minutes before starting the test.

PI-R0182CHT Rev A3.3

12/2022

CTK Biotech, Inc.

support@immuview.com

Call center 1-833-919-0617

https://immuviewathome.com

INTENDED USE FREQUENTLY ASKED QUESTIONS

WARNINGS, PRECAUTIONS & SAFETY INFORMATION

LIMITATIONS

HEALTHCARE PROVIDERS

STORE

COLLECT SAMPLE Children ages 14 to 17 may self-test with adult supervision. Do not touch your cheeks, teeth, 

gums, or any other surfaces with the fabric tip of the swab, or it might contaminate your sample. 

DO NOT touch the fabric tip of the swab with your hands.

9 • Carefully insert fabric tip of the swab 1/2 to 3/4 of an inch into first nostril. 

• With children, the maximum depth of insertion into the nostril may be less than 3/4 of an inch, and you may 

need to have a second person to hold the child’s head while swabbing.

• DO NOT insert the swab any deeper if you feel strong resistance or pain. If self-testing, use a mirror to help.

• Slowly rub swab in a complete circle around the inside of the nostril at least 5 times. 

• Using the SAME SWAB, repeat process in the second nostril.

• Children under age 14 should be tested by an adult (wear a face cover when swabbing others).

PROCESS THE SWAB SAMPLE

10

• Remove the buffer tube from the rack.

• Insert the fabric tip of the swab into the tube.

• Swirl the swab in the liquid for 15 seconds.

TEST THE SAMPLE

13 • Open the pouch labeled “COVID-19 Antigen 14

Home Test” and remove the test cassette. Do 

not use after the test cassette has been 

opened for more than 30 minutes. 

• Lay the cassette on clean, flat, well-lit surface.

• Invert the buffer tube over the cassette and gently squeeze to slowly add 3 drops of the liquid 

into the sample well (S), avoiding forming bubbles.

• Immediately start timing 15 minutes and wait. DO NOT move the cassette during the test.

SAFELY DISPOSE OF USED TEST

16

When done testing, dispose of used 

items (except Instructions For Use) 

in a trash can (not recycling) or 

according to your local guidelines. 

Thoroughly wash or sanitize your 

hands and any surfaces and items 

used during testing.

READ THE RESULT

15

Read result after 15 

minutes.

You must read the result 

after 15 minutes, but not 

past 30 minutes.

Negative Positive

If the Control (C) line is visible, but the Antigen (Ag) line is not visible, the test is Invalid

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 the individual does 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 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.

If the Control (C) line and the Antigen (Ag) line are visible, the test is positive. 

Any faint visible red test (Ag) 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).

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

invalid. Re-test with a new swab and new 

test device.

TEST INTERPRETATION

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

table 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. 

Status on First 

Day of Testing

First Result

Day 1

Second Result

Day 3

Third Result

Day 5 Interpretation

With 

Symptoms

Without 

Symptoms

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

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

Negative Positive N/A Positive for COVID-19

Negative Negative Positive Positive for COVID-19

Negative Negative Negative Negative for COVID-19

Chemical Name Harms (GHS Code) for each 

ingredient at stock for reference only: Concentration

Tergitol 15 S-9 H302, H332, H315, H318, H401

H302, H312, H314, H317, H332, H411

H300, H400, H410

0.4%

0.1%

0.095%

ProClin 300

Sodium azide

7 8 • Push in the perforated circle on the 

kit box and place buffer tube.

• Slowly peel off the buffer tube seal.

• Place the open tube in the rack.

Open the swab packaging and 

hold the swab by its handle.

DO NOT touch the fabric tip.

11 12 • Remove the swab from the tube while 

squeezing tube into the swab tip to 

press out excess liquid.

• Place the tube back into tube rack.

Insert the nozzle into the tube 

while holding the tube with 

your other hand. It should fit 

snug like a cork.

Add the liquid drop by drop in a vertical manner.
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PM-R0182CHT-2T Rev. B2.1

kit box design for COVID-19 Ag Home Test, 2 test/kit, Revision B2.1.

size 135 x 80 x 30mm

Items needed, but not provided:

Timer, tissues, soap and water or hand sanitizer, mirror (optional) 

For Emergency Use Authorization (EUA) only. | For  diagnostic use. | Ages 2 and up.

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

emergency use (EUA). This product has been authorized only for the detection of antigen protein 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. This product 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. 

 CTK Biotech, Inc.

13855 Stowe Drive, 

Poway, CA 92064, USA

support@immuview.com

https://immuviewathome.com

Call Center +1-833-919-0617

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

room temperature for 30 minutes before starting the test.If you stored the kit in an area colder than 59°F (15°C), leave it at Keep away from direct sunlight and do not store it in a freezer.Store in a dry place, at 35°F-86°F (2-30°C)

√

Scan to access 

product website

For Emergency Use Authorization (EUA) only

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Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours 

between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial 

(repeat) testing. Please read all the information in the enclosed instruction for use before performing the test.
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® 

Antigen

Home Test COVID-19 

For Emergency Use Authorization (EUA) only

5 Tests



5 Tests

5 x 5 x

5 x 5 x

1 x Instructions for Use (EN/ES)

Items needed, but not provided:

Timer, tissues, soap and water or 

hand sanitizer, mirror (optional) 

®

Antigen COVID-19 Home Test

For Emergency Use Authorization (EUA) only

5 Tests

Scan to access 

product website

R0182CHT

Store in a dry place, at 35°F-86°F (2-30°C)

Keep away from direct sunlight and do not store it in a freezer.

If you stored the kit in an area colder than 59°F (15°C), leave it at 

room temperature for 30 minutes before starting the test.

√ For Emergency Use Authorization (EUA) only. | For  diagnostic use. | Ages 2 and up.

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

emergency use (EUA). This product has been authorized only for the detection of antigen protein 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. This product 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. 

 CTK Biotech, Inc.

13855 Stowe Drive, 

Poway, CA 92064, USA

support@immuview.com

https://immuviewathome.com

Call Center +1-833-919-0617

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

udi code space.JPG

PM-R0182CHT-5T Rev. B2.1

Kit box design for COVID-19 Ag Home Test, 5 test/kit, Revision B2.1.

size 135 x 110 x 40 mm

Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours 

between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial 

(repeat) testing. Please read all the information in the enclosed instruction for use before performing the test.
20 Tests

®

Antigen COVID-19 Home Test

For Emergency Use Authorization (EUA) only

For Emergency Use Authorization (EUA) only

20 Tests

20 x 20 x

20 x 20 x

4 x Instructions for Use (EN/ES)

Items needed, but not provided:

Timer, tissues, soap and water or 

hand sanitizer, mirror (optional) 

Scan to access 

product website

20 Tests

Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours 

between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial 

(repeat) testing. Please read all the information in the enclosed instruction for use before performing the test.

80

30

40

45

C 

M

Y

K

0

75

98

13

C 

M

Y

K

PM-R0182CHT-20T Rev. B2.1

Kit box design for COVID-19 Ag Home Test, 20 test/kit, Revision B2.1.

size 220.5 x 135.5 x 80.5 mm

Store in a dry place, at 35°F-86°F (2-30°C)

Keep away from direct sunlight and do not store it in a freezer.

If you stored the kit in an area colder than 59°F (15°C), leave it at room temperature for 30 minutes before starting the test.

√

For Emergency Use Authorization (EUA) only. | For  diagnostic use. | Ages 2 and up.

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

emergency use (EUA). This product has been authorized only for the detection of antigen protein 

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. 

This product 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. 

 CTK Biotech, Inc.

13855 Stowe Drive, 

Poway, CA 92064, USA

support@immuview.com

https://immuviewathome.com

Call Center +1-833-919-0617

For information about current expiration dates for at-home OTC 

COVID-19 diagnostic tests, visit At-Home OTC COVID-19 Diagnostic Tests 

udi code space.JPG