SCoV-2 Ag Detect ™ Rapid Self -Test Instructions

For Emergency Use Authorization (EUA) only. In vitro diagnostic use only.
Carefully read these instructions before starting the test.
Materials Needed for Testing Prepare for the test
Test in pouch (Do not open until use) Swab Single-use dropper bottle Timing device (not included) 1. Wash hands or use hand 2. Remove one test from the packaging. Place the test on a fla
Your bottle may look different sanitizer before starting the test surface, like a counter or tabletop, in an area with good lighting
than the one shown

2. Remove one test from the packaging. Place the test on a flat surface, like a counter or tabletop, in an area with good lighting

It is recommended that gloves are used during testing. A face mask should be worn if swabbing someone else. Gloves and face mask are not provided.
Step 1: Swab Nostrils

1. Remove one swab from the packaging. Be 2. Carefully insert the swab at least 0.5 inch (1 3. Slowly rotate the swab using medium pressure at least four times, rubbing it along the insides of
careful not to touch the swab tip (soft end) cm) inside one nostril. nostril for 15 seconds. The swab tip should be touching the inside wall of the nostril through each
with hand. rotation. Using the same swab, repeat sample collection in the other nostril.

Only use the swab provided in the kit. • Improper swabbing may lead to false results. • Be sure to swab both nostrils with the same swab.
If swabbing another person, you should wear a face mask. • The swab may not need to be inserted as far into the nostrils if swabbing a child.
Step 2: Run the Test

1. Hold the top of the test firmly with 2. The swab should be flat in the test 3. Remove top of dropper bottle by 4. Hold the dropper bottle above the 5. Leave test untouched on a flat
one hand and place the swab tip (soft and cover the sample port. twisting the top plastic piece. Do not surface. Check the test results after
swab head. Slowly add all of the liquid
end) into the sample port. Gently push use mouth or teeth to open bottle. on top of the swab head. TWENTY (20) to TWENTY-FIVE (25)
the swab tip into the sample port while minutes.
Add 1 drop at a time until dropper
pressing the swab handle down. The is empty. Do not add the liquid all
swab should be firmly in the test. at once.

IMPORTANT!
Invalid or incorrect results can occur when less
than the whole bottle is added to the test. Make
sure to add all of the liquid slowly holding the
bottle vertically, 0.5 inches above the swab head.
IMPORTANT! IMPORTANT! False negative results can occur when the order IMPORTANT!
Hold swab close to the tip so it does of test steps is not correctly followed. Always add
The swab should cover the sample port the swab to the sample port, and then add the Incorrect results may occur if tests are read
not break when putting in the test. completely. liquid on top of the swab head in the test before 20 minutes or after 25 minutes.
cassette.

Step 3: Check Test Results

Positive Result Negative Result Invalid Result

If the control (C) line and the test (T) line are visible, the test is If the control (C) line is visible, but the test (T) line is not visible, the If the control (C) line is not visible, the test is invalid. Re-test
positive. Any faint visible pink test (T) line with the control line (C) test is negative. with a new swab and new test device.
should be read as positive.
To increase the chance that the negative result for
You do not need to perform repeat testing if you have a COVID-19 is accurate, you should:
positive result at any time. • Test again in 48 hours if you have symptoms on the
A positive test result means that the virus that causes COVID-19 was first day of testing.
detected in your sample and it is very likely you have COVID-19 and • Test 2 more times at least 48 hours apart if you do not
are contagious. Please contact your doctor/primary care physician have symptoms on the first day of testing.
or your local health authority immediately and adhere to the local
A negative test result indicates that the virus that causes COVID-19
guidelines regarding self-isolation. There is a very small chance that
this test can give a positive result that is incorrect (a false positive). 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 Turn over for further instructions how to understand your results and determine if
shortness of breath) you should seek follow up care with your repeat testing is necessary.
healthcare provider.
 How to Use this Test Test Interpretation
• Serial testing should be performed in all individuals with negative results; individuals with symptoms of Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID
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 Status on First Day of Testing First Result Day 1 Second Result Day 3 Third Result Day 5 Interpretation
serial (repeat) testing.
• If you test negative but continue to have symptoms of COVID-19, and both your first and second tests are Positive N/A N/A Positive for COVID-19
With Symptoms
negative, you may not have COVID-19, however you should follow-up with your healthcare provider.
Negative Positive N/A Positive for COVID-19
• If your test is positive, then proteins from the virus that causes COVID-19 have been found in your sample and With Symptoms
you likely have COVID-19. With Symptoms
Negative Negative N/A Negative for COVID-19

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

Without Symptoms
Negative Positive N/A Positive for COVID-19
Without Symptoms
Negative Negative Positive Positive for COVID-19
Without Symptoms
Negative Negative Negative Negative for COVID-19
Without Symptoms

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.

Please notify your healthcare provider of positive or negative results from the SCoV-2 Ag Detect ™ Rapid Self-Test

Stability Intended Use

• The kit should be stored at room temperature (15-30°C or 59-86°F) for the duration of its shelf life. The SCoV-2 Ag Detect™ Rapid Self-Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid
• Exposure to temperatures over 30°C or 86°F can impact the performance of the test and should be minimized. protein antigen from the SARS-CoV-2 virus.

• The kit should not be frozen or refrigerated. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 or
older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals
• For more information on expiration dating for COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests.
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
Warnings and Precautions 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.
• 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. The SCoV-2 Ag Detect™ Rapid Self-Test does not differentiate between SARS-CoV or SARS-CoV-2.
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares)
emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient
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, history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or
and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. co-infection with other viruses and the agent detected may not be the definitive cause of disease. Individuals who test positive with the
• Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for SCoV-2 Ag Detect™ Rapid Self-Test should self-isolate and seek follow up care with their physician or healthcare provider as additional
symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to testing may be necessary.
purchase additional tests to perform this serial (repeat) testing. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed.
• 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 Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management
between tests. 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.
• 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. 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.
• Do not use on anyone under 2 years of age.
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and to receive
• Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
appropriate medical care. All healthcare providers will report all test results they receive from individuals who use the authorized product to
• Do not use if any of the test kit contents or packaging is damaged. relevant public health authorities in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes,
• Test components are single-use. Do not re-use. as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Page 2 of 19 Mapping for SARS-CoV-2 Tests provided by CDC.
• Do not use kit past its expiration date. 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
• Do not touch the swab tip. aged 2 years or older in a non-laboratory setting. The SCoV-2 Ag Detect™ Rapid Self-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.
• Once opened, the test should be used within 30 minutes.
• Do not read test results before 20 minutes or after 25 minutes. Results read before 20 minutes or after 25 minutes may lead to a false Frequently Asked Questions
positive, false negative, or invalid result. What are the known and potential risks and benefits of the test?
• Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin, eyes, nose, or Potential risks include:
mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If the solution contacts your • Possible discomfort during sample collection.
skin, eyes, nose, or mouth, flush with large amounts of water. • Possible incorrect test result (see Warnings and Result Interpretation sections for more information).
• If irritation persists, seek medical advice: https://poisonhelp.org or 1-800-222-1222. Potential benefits include:
• The results, along with other information, can help you and your healthcare provider make informed recommendations about your care.
Hazardous Ingredients • 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-and-response/mcm-legal-regulatory-and-policy-
Chemical Names GHS Code for each Ingredient Concentrations
framework/emergency-use-authorization
What is the difference between an antigen and molecular test?
IGEPAL® CA-630 H302, harmful if swallowed ≤3.0%
There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests detect genetic material from the virus.
H315, causes skin irritation Antigen tests, such as the SCoV-2 Ag Detect™ Rapid Self-Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests,
H318, causes serious eye damage 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?
ProClinTM 300 H302, harmful if swallowed ≤0.05% Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19
H314, causes severe skin burns and eye damage when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to
H317, may cause an allergic skin reaction minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you,
H318, causes serious eye damage
please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at inbios.com/scov-2-ag-detect-self-test/.
H332, harmful if inhaled 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
• For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and- sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result.
policy-framework/emergency-use-authorization What if I have a negative test result?
• For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19 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
Limitations 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
• There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of 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
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 and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you
compared to a molecular test, especially in samples with low viral load. should take.
What does an invalid test result mean?
• The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between
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
September 2021 and October 2021. The clinical performance has not been established for all circulating variants but is anticipated to
a new nasal specimen and you should test again with a new test.
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 Important
over time. 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.
• All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary. If you continue to Individuals should provide all results obtained with this product to their healthcare provide
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.

InBios International, Inc. Patent Pending For questions or to learn more about this product visit www.inbios.com/scov-2-ag-detect-self-test/
307 Westlake Ave. N., #300
Seattle, WA 98109 Part No: 900317-04 or call 866-516-0757 (US Toll Free).

www.inbios.com