INSTRUCTIONS FOR USE

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.

SCAN HERE FOR A 

STEP-BY-STEP VIDEO

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.

YOU WILL NEED A WAY TO TIME THE TEST

Wash your hands thoroughly with soap and 

water for 20 seconds before starting the test.

Pick up the two-part pouch. Tear open the 

pouch containing the tube and 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.

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.

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.

Tear open the pouch containing the test device

and remove.

DO NOT touch 

the flat pad

with your fingers

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

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.

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.

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.

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”.

there is a line 

next to the “T” 

and NO line 

next to the “C”.

there is a 

faint line next 

to the “T” and 

a line next to 

the “C”. 

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.

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)

a reddish-purple 

background 

makes it 

impossible to 

read the test after 

30 minutes

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

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.

REPORTING RESULT

Call your healthcare provider and use the InteliSwab® Connect app to report your 

result. To access the app visit www.InteliSwab.com/app. 

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.

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 InteliSwab® Connect app. 

The app 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: https://www.poisonhelp.org or 

1-800-222-1222.

For more information on EUAs please visit: https://www.fda.gov/

emergencypreparedness-and-response/mcm-legal-regulatory-andpolicy-framework/emergencyuse-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-policyframework/emergencyuse-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

MORE QUESTIONS ABOUT THE 

INTELISWAB® COVID-19 RAPID TEST?

Contact our toll-free consumer helpline at 1-833-601-0127 

or visit www.InteliSwab.com.

The InteliSwab® COVID-19 Rapid Test Letter of Authorization, authorized 

Fact Sheets and authorized labeling are available on the FDA website and

www.InteliSwab.com.

OraSure Technologies, Inc.

220 East First Street

Bethlehem, PA 18015 USA

(610) 882-1820

www.OraSure.com

© 2022 OraSure Technologies, Inc. 3001-3679 rev. 01/23
1 TEST

1 TEST actual size

SMART SCIENCE

MADE SIMPLETM

GENTLE SHALLOW 

NASAL SWAB

HOME TEST

RESULTS IN 

MINUTES

ANYTIME,

ANYWHERE

SIMPLE &

CONVENIENT

TESTING

No assembly 

required

— ready to use

No waiting for 

mail or lab 

processing

SIMPLY

SWAB, SWIRL

AND SEE

LEARN

MORE

FPO YYYY-MM-DD

XXXXXX

XXXXXX

MOraSure Technologies, Inc.

220 East First Street | Bethlehem, PA 18015 USA

(+1) 610-882-1820 | www.OraSure.com

© 2022 OraSure Technologies, Inc. 

3001-3701 rev. 12/22

Swab 

both

nostrils

Swirl

in the 

tube

See

your

results

Item #3001-3701-70

rev. 1/23

The InteliSwab® COVID-19 Rapid Test detects active infection in 

individuals 2 years and older. See Instructions for Use for full 

intended use. 

QUICK AND EASY RESULTS 

• Use at home or anywhere there is a flat surface

• No professional supervision or video consultation required

• No phone or other equipment needed to interpret results

CONTENTS

• One (1) pouch, with:

• Single-use test device

• Tube with developer fluid

• Instructions for Use in English and Spanish

• Test stand

You will need a way to time the test for 30 minutes (a watch, 

clock or cellphone). To report results to public health, visit 

www.InteliSwab.com/app.

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.

Store the InteliSwab® COVID-19 Rapid Test in a dry location 

between 35°-86°F (2°-30°C).

For information about current expiration dates for at-home OTC 

COVID-19 diagnostic tests, visit http://www.fda.gov/covid-tests

QUESTIONS? Go to www.InteliSwab.com or call 1-833-601-0127

Instrucciones de use en español 

ubicadas dentro de la caja.

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use

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

authorized by FDA under an EUA.

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 test does NOT determine if you had COVID-19 in the past or if you have 

immunity.

This product has been authorized only for the detection of proteins from 

SARS-CoV-2, not for any other viruses or pathogens.

See side panel for more information on expiration dates.
2 TESTS

2 TESTS actual size

SMART SCIENCE

MADE SIMPLETM

GENTLE SHALLOW 

NASAL SWAB

HOME TEST

RESULTS IN 

MINUTES

ANYTIME,

ANYWHERE

SIMPLE &

CONVENIENT

TESTING

No assembly 

required

— ready to use

No waiting for mail 

or lab processing

SIMPLY

SWAB, SWIRL

AND SEE

Swab

both

nostrils

Swirl

in the 

tube

See

your

results

LEARN

MORE

FPO YYYY-MM-DD

XXXXXX

XXXXXX

Item #3001-3703-70

rev. 1/23

The InteliSwab® COVID-19 Rapid Test detects active infection in 

individuals 2 years and older. See Instructions for Use for full 

intended use. 

QUICK AND EASY RESULTS 

• Use at home or anywhere there is a flat surface

• No professional supervision or video consultation required

• No phone or other equipment needed to interpret results

CONTENTS

• Two (2) pouches, each with:

• Single-use test device

• Tube with developer fluid

• Instructions for Use in English and Spanish

• Test stand

You will need a way to time the test for 30 minutes (a watch, 

clock or cellphone). To report results to public health, visit 

www.InteliSwab.com/app. 

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.

Store the InteliSwab® COVID-19 Rapid Test in a dry location 

between 35°-86°F (2°-30°C).

QUESTIONS? Go to www.InteliSwab.com or call 1-833-601-0127

Instrucciones de use en español 

ubicadas dentro de la caja.

© 2022 OraSure Technologies, Inc. 3001-3702 rev. 12/22

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

authorized by FDA under an EUA.

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 test does NOT determine if you had COVID-19 in the past or if you have 

immunity.

This product has been authorized only for the detection of proteins from 

SARS-CoV-2, not for any other viruses or pathogens.

MOraSure Technologies, Inc.

220 East First Street, Bethlehem, PA 18015 USA

(+1) 610-882-1820 www.OraSure.com

For information about current expiration dates for at-home OTC 

COVID-19 diagnostic tests, visit http://www.fda.gov/covid-tests

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use