The ImmuView® COVID-19 Antigen Home Test is designed
to let you easily perform a COVID-19 self test.
FDA EUA – OTC COVID-19 Antigen Home Test for Ages 2 and Older: The ImmuView® COVID-19 Antigen Home Test is intended for the detection of SARS-CoV-2 (the virus that causes COVID-19). This self-administered test is for individuals ages 14 years and older. Adult collection is required for testing children ages 2-13 years old.
Fast Results in 15 minutes
The test is positive when you have two visible lines visible.
The C line shows that the control worked.
The Ag line in shows that COVID-19 virus has been detected. A positive antigen test develops a C-line and an Ag line.
Every visible Ag line is a positive result regardless of band intensity.
Click here to view the CDC’s Guidelines
The test result is negative when you see a line in front of the C only. A negative antigen test only develops a C-line.
If your test is negative, but you’re experiencing symptoms of COVID-19, please see your healthcare provider for next steps.
Click here to view the CDC’s Guidelines
If the test does not work as, it should (e. g. by not developing a line in front of C), the test must be considered INVALID. No C-line means your result is invalid.
Try taking a new test. If you get the same result, please contact us through here.
DO’S
DON’TS
COVID-19 is caused by the SARS-CoV-2 virus, a new virus in humans causing a contagious respiratory illness. COVID-19 can present with mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age with underlying medical conditions have a higher risk of severe illness from COVID-19. Severe outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A complete list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
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.
Serial testing is when a single person is tested for COVID-19 more than once. Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.
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.
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Services (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs unless terminated or revoked (after which the test may no longer be used).
As of January 15, 2022, over-the-counter COVID-19 tests approved under the FDA Emergency Use Authorization (EUA) are eligible to be reimbursed by your private insurance. Learn more here.
For more information on Medicare and OTC COVID-19 Tests, click here
| Contents of 2 Test Kit: | x2 “Buffer and Nozzle” pouches | x2 Cassette Pouches | x2 Swabs | x1 Instructions for Use |
| Contents of 5 Test Kit: | x5 “Buffer and Nozzle” pouches | x5 Cassette Pouches | x5 Swabs | x1 Instructions for Use |
| Contents of 20 Test Kit: | x20 “Buffer and Nozzle” pouches | x20 Cassette Pouches | x20 Swabs | x4 Instructions for Use |
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).
The shelf life is 12 months from the date of manufacture. Do not use the test after the expiration date, which is printed onto each 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
No. The nasal swab isn’t sharp, has a fabric tip, and should not hurt. Sometimes the swab can cause slight discomfort. If you feel pain, stop the test and seek advice from your healthcare provider.
Potential risks include:
Potential benefits include:
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
Our team regularly monitors the COVID-19 landscape to ensure that any emerging variants do not impact the performance of the ImmuView® COVID-19 Antigen Home Test. Read the white paper supporting that our test can detect all variants of concern, including Omicron (BA.1, BA.2, BA.4, BA.5 lineages); click here
Yes, this test is intended for home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older.
Children aged 2 to 13 should NOT swab themselves and be swabbed by an adult. If you are unsure of how to take a sample after reading the instructions for use, please get in touch with a COVID-19 test center or a physician for help.
No, the ImmuView® COVID-19 Antigen Home Test is a single-use test and cannot be reused.
The COVID-19 testing guidance for airlines and cruise ships varies by country of origin and destination. Please check the CDC for the most up-to-date travel guidance and confirm directly with your ticketing airline/cruise ship. The ImmuView® COVID-19 Antigen Self-Test currently doesn’t have an affiliation with a telehealth service provider (proctoring) or any associated apps to monitor users while they administer their tests and provide certification of a negative test to travel.
The UPC Code for the 2-test kit is 855402007955. For the 5-test kit, the UPC Code is 855402007962.
Yes, this test is an eligible expense that can be reimbursed under FSAs.
No, you do not need insurance to purchase this test. The ImmuView® COVID-19 Antigen Home Test is for over the counter (OTC) use.
No, you do not need a prescription to purchase this test. The ImmuView® COVID-19 Antigen Home Test is for over the counter (OTC) use.
The ImmuView® COVID-19 Antigen Home Test has been validated for exposure to freezing conditions during shipping. If the test was exposed to temperatures below 59○ F, ensure it is brought to room temperature before using.
The ImmuView® COVID-19 Antigen Home Test has been validated for exposure to high temperatures during shipping. If the test was exposed to temperatures up to 113○ F, ensure it is brought to room temperature before using.
Yes, you need to swab both nostrils. Failure to swab both nostrils may lead to inaccurate test results. Please follow the Instructions for Use provided with your test kit.
No, test the sample immediately after swabbing your nose.
No, the ImmuView® COVID-19 Antigen Home Test is only to be used with nasal swab specimens.
No, this may cause bubbles and result in incorrect droplet volumes.
You should dispense 3 drops of solution into the cassette Sample Well marked with an “S”.
The volume filled in each tube has been validated for the performance of the test.
There is enough buffer solution to perform the test, even if the entire swab tip is not covered.
There is enough buffer solution to perform the test, even if the entire swab tip is not covered.
For the test to provide an accurate result, you must apply 3 drops of liquid to the test cassette sample well, the one marked with an “S”. If your tube contained only enough liquid for 2 drops, you must repeat the test with a new cassette and a newly collected specimen sample.
No, for the test to provide an accurate result, you must apply 3 drops of liquid to the test cassette. You must repeat the test with a new cassette and a newly collected specimen sample.
No, the ImmuView® COVID-19 Antigen Home Test does not require special equipment or apps to interpret results. If you have questions regarding the interpretation of results, please review the Instructions for Use or contact us at support@immuview.com
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 visible, but the Antigen (Ag) 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 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 is not visible, the test is invalid. Re-test with a new swab and new test device. If the problem persists, contact customer service at 1 (833) 919-0617. Available Hours: Mon. to Fri.: 9 a.m. – 5 p.m. PST) or email us at support@immuview.com.
Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID-19.
| Status on First Day of Testing | First Result
Day 1 |
Second Result
Day 3 |
Third Result
Day 5 |
Interpretation |
| With Symptoms | 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 | |
| Without Symptoms | 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 |
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.
Yes, as long as the control (C) line is visible, the test result is valid.
The C- line may fail to appear if the instructions for use aren’t followed correctly. Examples of this include using an expired test, incorrectly swabbing, or wrong sample volume
Every visible Ag line is a positive result regardless of band intensity. If in doubt, repeat the test or contact your healthcare provider for additional assistance.
A pinkish background color on the test strip will not affect the result of your test.
A false positive is when a test result indicates a person has a specific disease or condition when the person does not have the disease or condition. A false-negative test result indicates a person does not have a specific disease or condition when the person does have the disease or condition. Incorrect specimen collection and sample preparation can result in false-negative and false-positive test results. Therefore, before you begin the test, it is crucial to read the package insert provided in the test package and follow the instructions.
The buffer should only be used as directed; do not ingest; keep out of the reach of children; avoid contact with skin and eyes.
The reagent solution contains harmful chemicals (see table below). If the solution contacts your [e.g., 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 | Harms (GHS Code) for each ingredient at stock for reference only: | Concentration |
| Tergitol 15 S-9 | H302, H332, H315, H318, H401 | 0.4% |
| ProClin 300 | H302, H312, H314, H317, H332, H411 | 0.1% |
| Sodium Azide | H300, H400, H410 | 0.095% |
Do not use the kit. For assistance, contact customer service at 1 (833) 919-0617. Available Hours: Mon. to Fri.: 9 a.m. – 5 p.m. PST) or email us at support@immuview.com.
The instructions included in the kit may be found here. For assistance, contact customer service at 1 (833) 919-0617. Available Hours: Mon. to Fri.: 9 a.m. – 5 p.m. PST) or email us at support@immuview.com.
Do not use the kit. Clean any surface where the buffer may have been spilled, and wash your hands after.
The solution should be clear and colorless. If you receive a solution that has a yellow color, do not use this test kit. For assistance, contact customer service at 1 (833) 919-0617. Available Hours: Mon. to Fri.: 9 a.m. – 5 p.m. PST) or email us at support@immuview.com.
Swabs can have a slight off-white color to them and should not affect the performance of the product if the swab was sealed/unopened.
If you have a question about your test and would like to request support from our Technical Support team, please fill out the form below. To help us process your information quickly and effectively, please provide as much information as possible. If you would like to speak to one of our Technical Support team members, please call +1-833-919-0617
CTK Biotech is part of the SSI Diagnostica Group.
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.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-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