SCoV-2 Ag Detect™ Self-Test2022-06-13T20:38:40+00:00

Let’s Keep Each Other Healthy!

Easy, Fast, At-Home Testing for COVID-19

SCoV-2 Ag Detect™ Rapid Self-Test

How it Works

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Uniquely Designed for Simplicity

Directly test your nasal swab sample.
No mixing needed!

Swab

Test

Read Results

See Instructions for Use for a step-by-step guide to performing the test.
SCoV-2 Ag DetectTM Rapid Test

Fast, Easy, Test at Home

The SCoV-2 Ag Detect™ Rapid Self-Test’s patent pending design has been developed to be incredibly simple to use. It uses a shallow nasal swab (inserted just one-half inch) and offers easy-to-read results – all in the time it takes to drink your morning latte, go for a mile run or read a couple of chapters in your latest novel.

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SCoV-2 Ag Detect™ Rapid Self-Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first five days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first five days of symptom onset. This test is also 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, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The SCoV-2 Ag Detect™ Rapid Self-Test does not differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs 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 SCoV-2 Ag Detect™ Rapid Self-Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results should be treated as presumptive, 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 decisions. 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 and confirmed with a molecular assay, if necessary, for patient management.

For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of COVID-19, such as, an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.

Individuals who test negative and continue to experience COVID-like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care from their healthcare provider.

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting. 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 SCoV-2 Ag Detect™ Rapid Self-Test is intended for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older. The SCoV-2 Ag Detect™ Rapid Self-Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The SCoV-2 Ag Detect ™ Rapid Self-Test is available online through Amazon.

For information on distribution, contact us here.

Frequently Asked Questions
SCoV-2 Ag Detect ™ Rapid Self-Test

Is this test authorized by the US FDA?2022-05-19T22:45:12+00:00

InBios received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the SCoV-2 Ag Detect™ Rapid Self-Test on Nov. 22, 2021.

What is the EUA number for this kit?2022-05-19T22:45:31+00:00

EUA210619

What is the InBios SCoV-2 Ag Detect™ Rapid Self-Test?2022-05-26T23:02:57+00:00

It is a test to detect proteins (called antigens) from the virus that causes COVID-19. A positive result means that it is very likely you have COVID-19, and it is important to be under the care of your healthcare provider. The test can be performed using shallow nasal swab samples, requires no mixing step, and takes ~20 minutes to obtain results. This test is authorized for non-prescription home use.

Do I need a prescription for this test?2022-05-19T22:51:39+00:00

No. It is authorized for over-the-counter use.

Does insurance cover the cost of the test?2022-05-19T22:52:20+00:00

Insurance may cover some or all of the cost of your test. Please consult with your specific health insurance provider to determine if your test will be covered. Reimbursement and free-of-charge tests are not provided by InBios. Additional information on coverage and reimbursement can be found at this link to the Centers for Medicare and Medicaid.

How many tests come in each box?2022-06-10T23:34:30+00:00

The SCoV-2 Ag Detect™ Rapid Self-Test is available in a 2 tests per kit configuration. Each kit includes everything you need to perform 2 tests (swabs, test cassettes and dropper bottles) as well as detailed instructions for use. An instructional video is also available here.

What is the shelf life of the test?2022-06-06T23:34:25+00:00

Thirteen months from the date of manufacture.

How can I check on the extended shelf life of my test?2022-06-10T22:36:49+00:00

Please contact InBios here

How do I store the test?2022-05-26T23:01:01+00:00

At room temperature (15-30°C/59-86°F).

Who can use this test?2022-05-19T22:54:53+00:00

This test can be used by individuals aged 14 years and older or with adult-collected nasal swabs from children as young as 2 years old.

How do I test myself or someone else?2022-05-19T22:55:27+00:00

The SCoV-2 Ag Detect™ Rapid Self-Test’s patent pending design has been developed to be incredibly simple to use, even for someone who has not self-tested before. It utilizes a nasal swab (inserted just one-half inch) to keep discomfort at a minimum.

Do I need instruments to perform the test?2022-05-19T22:55:59+00:00

No, this test requires no additional instrumentation and results can be read visually. You will need a timer or stopwatch to time the test.

How fast do I get results?2022-05-19T22:56:19+00:00

Your results will be ready in 20 minutes. Do not read results before 20 minutes or after 25 minutes.

Will the test hurt?2022-05-19T22:56:49+00:00

No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider.

What are the known and potential risks and benefits of this tests?2022-05-19T22:57:27+00:00

Potential risks include possible discomfort during sample collection and/or possible incorrect tests results (refer to the “Understanding Your Test Results” section of the instructions). Potential benefits include helping your healthcare provider to make informed recommendations about your care and helping limit the spread of COVID-19 within your family and community.

How do I know if I have a positive or a negative result?2022-05-19T22:58:22+00:00

The test is positive if a control line and a test line both show on the cassette. Be sure to look closely – even a faint line indicates a positive result. The test is negative when only the control line appears. The test is invalid if no control line appears, whether or not there’s a test line.

What does it mean if I get a positive result?2022-05-19T22:58:53+00:00

The test is positive if a control line (“C”) and test line (“T”) both show in the marked areas on the test. This means that COVID-19 antigen was detected. A positive test result means that proteins from the virus that causes COVID-19 were found in your sample. It is very likely you have COVID-19 and it is important to be under the care of your healthcare provider. It is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give you a positive test result that is wrong (false positive). If you test positive with the SCoV-2 Ag Detect™ Rapid Self-Test, you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary. Your healthcare provider will work with you to determine how best to care for you based on your test results, medical history, and symptoms.

What does it mean if I get a negative result?2022-05-19T22:59:23+00:00

A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. Read the Serial Testing Information section below if you test negative and are not experiencing COVID-19 like symptoms. Negative results do not rule out SARS-CoV-2 infection. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If you test negative and continue to experience COVID-19 like symptoms of fever, cough, and/or shortness of breath you should seek follow up care with your healthcare provider. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. For example, your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the next steps you should take.

What does an invalid result mean?2022-05-19T22:59:51+00:00

If no control line shows up on the test, the result is invalid (even if any test line shows up). 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 the test should be run again, using a new test and dropper bottle.

Do I have to test more than once?2022-05-19T23:00:18+00:00

The test can be used by individuals with or without symptoms. If you have experienced COVID-19 symptoms in the past 5 days, you only need to test 1 time. If you have no symptoms, test 2 times over 3 days (with at least 24 hours and no more than 48 hours between tests). This is called serial testing.

What is serial testing?2022-05-19T23:00:45+00:00

Serial testing is when a single person is tested for COVID-19 more than once. Because antigen tests are less sensitive than other COVID-19 tests and false results may occur, repeated testing may identify more individuals with COVID-19 infection than a single test. By repeating testing, it may be possible to identify cases of COVID-19 infection and reduce spread of infection more quickly. Additional testing with a molecular COVID-19 test may be necessary, depending on your individual risk factors and test results. It is important that you work with your healthcare provider to help you understand the next steps you should take. Serial testing (i.e., testing twice over three days) is more likely to detect COVID-19, especially when you do not have any symptoms.

What is the difference between an antigen and a molecular test?2022-05-19T23:02:46+00:00

An antigen test, such as the SCoV-2 Ag Detect™ Rapid Self-Test, detects proteins from the virus. Molecular tests detect genetic material from the virus. Antigen tests are very specific for the virus, but not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider about whether an additional test is necessary and if you should continue isolating at home. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19.

Do I have to be vaccinated to use this test?2022-05-19T23:03:39+00:00

No. Individuals can utilize this test regardless of vaccination status.

Can this test be used as proof of a negative COVID test for travel?2022-05-19T23:04:08+00:00

The SCoV-2 Ag Detect™ Rapid Self-Test does not provide documentation of a test result for this purpose. Please visit the website of your airline for up-to-date information about what is required. The CDC also provides information about requirements for international travel.

Is there a phone app for this test?2022-05-19T23:04:28+00:00

No.

Can I throw the SCoV-2 Ag Detect™ Rapid Self-Test in the garbage when I’m done testing?2022-05-26T23:02:23+00:00

Please recycle the box (it is 100% recyclable), but dispose of the swab, test cassette, and dropper bottle in common household waste.

Does this test detect COVID-19 variants?2022-05-26T23:03:31+00:00

Sequence analysis suggests our test will detect variants currently in circulation. We routinely monitor sequences deposited in GISAID and Nextstrain for emerging SARS-CoV-2 mutations and variants and pay special attention to CDC data on circulating rates, and variants defined by the CDC as Variants of Concern (VoC) and Variants of Interest (Vol). 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.

Where is this test manufactured?2022-06-10T23:35:36+00:00

The SCoV-2 Ag Detect™ Rapid Self-Test is manufactured in the USA.

Is this test FDA approved or cleared?2022-06-10T23:36:21+00:00

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.

Where can I find information about Emergency Use Authorizations (EUAs) and COVID-19?2022-05-19T23:06:58+00:00
What if I have a question or need help regarding the test?2022-06-10T23:31:16+00:00

Call 1-866-INBIOS1 or 206-344-5821 or submit an online inquiry.

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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