How to Use HTML | InteliSwab® COVID-19 Rapid Test

You must follow the test directions carefully to get an accurate result. Call OraSure Technologies at 1-833-601-0127 or visit www.InteliSwab.com to obtain the complete instructions for use. FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY.

IMPORTANT: Swabbing the nostrils is critical for obtaining an accurate result. If you do not swab your nose, the device will produce a false negative result.

HOW TO USE THE INTELISWAB® COVID-19 RAPID TEST

PREPARING FOR THE TEST

KIT CONTENTS:

Pouched device(s) with a device and a tube, Instructions for Use (in English and Spanish) and test stand.

A two part foil pouch with the test device and capped tube inside. Tear notches are in the top and bottom edges on the left.

A white plastic test stand with a flat rectangular bottom and an open space on the front end to hold a cylinder at an angle.

YOU WILL NEED A WAY TO TIME THE TEST

Wash your hands thoroughly with soap and water for 20 seconds before starting the test.

A hand removes the capped tube from the bottom half of a partially torn pouch. The cap is as wide as the tube and textured.

Pick up the two-part pouch. Tear open the pouch containing the tube and remove.

One hand holds the tube while the other pulls the cap up off of the tube.

ROCK CAP BACK AND FORTH TO REMOVE

With the tube in an upright position, GENTLY ROCK THE CAP BACK AND FORTH to remove it. DO NOT twist. DO NOT pour out the liquid. DO NOT drink. Save cap for disposal.

A hand sets the open tube in the test stand from the top at an angle.

Slide the tube into the test stand on a flat sturdy surface. DO NOT force from the front as splashing may occur. Tube should rest at an angle on the bottom of the stand. If the solution spills, you will need a new test

Person blowing their nose into a tissue.

Blow your nose into a tissue. If assisting someone, instruct them to blow their nose. DO NOT use tissue to clear out nasal passage. Discard tissue and wash hands thoroughly. Dry hands before starting the collection.

A hand removes the flat test device by the larger handle end from a tear in the top half of the pouch. The handle has a raised circle on it.

Tear open the pouch containing the test device and remove.

The test device has a main body with a raised circle and rounded corners on the top end and a thinner shaft piece that sticks out from the bottom. The shaft flares wider just before the swab tip, which is a soft, rectangular, flat pad. There is a narrow rectangular result window in the middle of the device marked C and T.

Crossed out image of a finger touching the flat swab tip.

DO NOT touch the flat pad with your fingers

If the preservative is not present, DO NOT use the test.

SWAB BOTH NOSTRILS

A person moves the flat swab tip around the inside of their right nostril while holding the test device by the rounded handle end.

A person moves the flat swab tip around the inside of their left nostril, still holding the test device by the rounded handle end.

ADULT: 15 TIMES

WHEN COLLECTING FROM A CHILD SEE ADDITIONAL INSTRUCTIONS

ADULTS: Insert flat pad of the device inside the nostril. Circle around the nostril 15 times while maintaining contact with the inside wall of the nostril. SWAB BOTH NOSTRILS (Fig. 1 and Fig. 2). If you are conducting a test on a child 15-17 years old or an adult who requires assistance, proceed by swabbing the individual.

CHILDREN (14 AND UNDER): When collecting from a child under the age of 15, slowly circle the swab in EACH nostril a minimum of 4 times while gently pressing against the inside of the nostril. This should take about 15 seconds. (Fig. 1 and Fig. 2).

If you DO NOT swab BOTH nostrils 15 times (adult) OR 4 times (child), you may get a false result.

One hand steadies the base of the test stand and tube. The other hand holds the test device so the flat swab tip is at the bottom of the tube.

Stir 10 times

Hold the test stand on a flat surface and insert the flat pad of the device into the tube. Stir 10 times to mix the sample with the liquid in the tube. Make sure the flat pad is toward the back of the tube so it contacts the liquid. Stirring the device less than 10 times may cause invalid results.

The test device rests loosely in the tube, which is sitting in the test stand at an angle. The result window and raised circle face up and away from the stand.

The tube and device will sit at an angle in the test stand

After mixing, leave the device in the tube. Make sure the flat pad is touching the bottom of the tube and the result window is facing you. Start your timer for 30 minutes. DO NOT remove the device from tube while the test is running.

A pink background will pass through the result window as the test is working.

30 minutes

Read results between 30 and 40 minutes. To obtain an accurate result, DO NOT read before 30 minutes or after 40 minutes.

Reading before 30 minutes may cause false negative results.

If you have a 2-pack test kit, keep the test stand and instructions for completing the additional test provided in the kit.

INTERPRETING RESULTS

Read test results in a well-lit area

POSITIVE RESULT COVID-19 DETECTED

The test is POSITIVE if

there is a line next to the “T” and a line next to the “C”.

The result window on the middle of the test device showing two horizontal, reddish-pink lines across the upper half of the window. There is a letter C to the left of the top line, and a letter T to the left of the bottom line.

there is a faint line next to the “T” and a line next to the “C”

there is a line next to the “T” and NO line next to the “C”.

The result window on the middle of the test device showing two horizontal, reddish-pink lines across the upper half of the window. The top line is next to the letter C. The lower line is fainter and next to the letter T.

Look very closely! Any line next to the “T” means COVID-19 has been detected. The line may be very faint.

Repeat testing does not need to be performed if patients 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). 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 InteliSwab® should self-isolate and seek follow up care with their physician or healthcare provider as 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.

If the “C” line and the “T” line are visible, the test is positive. Any faint visible “T” line with the “C” line should be read as positive

A series of 5 example result windows showing the two reddish pink lines next to the letters C and T, but with the T line increasingly faint until it is almost invisible.

NEGATIVE RESULT COVID-19 NOT DETECTED

READING BEFORE 30 MINUTES MAY CAUSE A FALSE NEGATIVE RESULT

The test is NEGATIVE if:

there is a line next to the “C” and NO line next to the “T”

There must be a line next to the “C” to be able to interpret negative result.

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 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. All negative results should be treated as presumptive and confirmation with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. 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 decisions.

INVALID RESULT

The test is not working and should be repeated if:

no lines are present

the line next to the “T” or the line next to the “C” is not complete (all the way across the window)

Two example result windows showing partial lines next to the letters C and T. One shows both lines extending only halfway across the window. The other shows a full C line, but only half a T line.

a reddish-purple background makes it impossible to read the test after 30 minutes

The result window on the middle of the test with reddish-pink discoloration along its length. No horizontal lines are visible.

You will need to re-test with a new test device.

The test did NOT work properly

Contact OraSure Technologies, Inc. at 1-833-601-0127

HOW TO USE THIS TEST FOR SERIAL (REPEAT) TESTING

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.

Repeat testing is needed to improve test accuracy. Please follow the table 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
With Symptoms	Negative	Positive	N/A	Positive for COVID-19
With Symptoms	Negative	Negative	N/A	Negative for COVID-19
Without Symptoms	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

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

REPORTING RESULT

Call your healthcare provider and use the website, MakeMyTestCount.org, to report your result.

DISPOSE

Remove the test device from the tube, put the cap back on the tube and throw away in normal trash. Once all devices have been used for testing, throw away all contents.

A person drops an object into a trash can.

Do NOT Reuse

INTENDED USE (IU)

The InteliSwab® COVID-19 Rapid 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 selfcollected anterior nasal (nares) swab samples from individuals aged 18 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 seven (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 InteliSwab® COVID-19 Rapid Test does not differentiate between SARS-CoV-1 and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal 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 co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the InteliSwab® COVID-19 Rapid 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 COVID-19 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 healthcare provider.

Individuals should report all results obtained with this product to their healthcare provider and using the MakeMyTestCount.org website. MakeMyTestCount.org will report all test results received 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 (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.

The InteliSwab® COVID-19 Rapid Test is authorized 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 InteliSwab® COVID-19 Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.

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 February through September 2021. 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.

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.

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION

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 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 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 18 years and older. Children age 2 to 17 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 swab should be used immediately.

Do not read test results before 30 minutes or after 40 minutes. Results read before 30 minutes or after 40 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 and eyes. Do not ingest any kit components. The solution in the tube contains potentially harmful chemicals (see table).

Chemical Name	GHS Code for each Ingredient	Concentrations
Triton X-100	H302, harmful if swallowed H315, skin irritation H318, serious eye damage H400, short-term (acute) aquatic hazard H410, long-term (chronic) aquatic hazard	0.2%
ProClin 950	H302, harmful if swallowed H332, harmful if inhaled H314, causes severe skin burns and eye damage H317, may cause an allergic skin reaction H335, respiratory irritation H410, long-term (chronic) aquatic hazard	0.1%

If the solution contacts the skin or eyes, flush with copious amounts of water. If irritation persists, seek medical advice: www.poisonhelp.org or 1-800-222-1222.

For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-andpolicy-framework/emergency-use-authorization

For the most up to date information on COVID-19, please visit:
www.cdc.gov/COVID19

FREQUENTLY ASKED QUESTIONS

What are the known and potential risks and benefits of this test?

Potential risks include:

Possible discomfort during sample collection.

Possible incorrect results (see Warnings and Interpreting Results 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 more information on EUAs go here: https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

What is the difference between a COVID-19 antigen test and a 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 InteliSwab® COVID-19 Rapid 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.

What if you test positive?
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 selfisolate from others and contact a healthcare provider for medical advice about your positive result.

What if you test negative?

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.

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 test device should be used to collect a new nasal specimen and you should test again.

Why do I have a test line and no control line?

If you have a test line and no control line, your test is positive. When the level of virus in the sample is high, the line next to the “C” may not be present or may be very faint. The line next to the “C” must be visible to read a negative test result.

How accurate is the InteliSwab® COVID-19 Rapid 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 www.inteliswab.com.

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.

For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit http://www.fda.gov/covid-tests

EXPLANATION OF SYMBOLS

Batch Code	Use By
Do Not Reuse	Caution, Consult Accompanying Documents
Temperature Limitation	Manufacturer
Catalog Number	Consult Instructions for Use
In Vitro Diagnostic Medical Device