Pilot® COVID-19 At-Home Test

Quick Reference Instructions for patients

For In Vitro Diagnostic (IVD) use. 

For use under the Emergency Use Authorization (EUA) only.

Carefully read the instructions before performing the test. Failure to follow the 

instructions may result in inaccurate test results.

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.

Materials Provided

Sterile Swab Tube with

Liquid (inside

foil pouch 2)

Nozzle Cap Tube Holder

Needed but not provided: Timer

Optional (for use with telehealth proctor only): 

Internet enabled device with audio and video capabilities

Test Device

(inside foil 

pouch 1)

NOTE: This test comes in a 1, 4 or 25 test quantity. The number of items 

supplied in the kit will vary depending on which kit is purchased.

Storage and Stability

Read and interpret the results

Prepare to perform the test

Test Procedure

000012

Store the kit at 36-86 °F / 2-30 °C and protect from direct sunlight. The expiry date of the materials is indicated on the external packaging. Do not freeze the kit. For more 

information on expiration dating of COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests.

1 Bring test kit to room temperature (59-86 °F / 15-30 °C).

Wash your hands with soap and 

water, or use hand sanitizer before 

performing the test. Make sure you 

rinse thoroughly and your hands are 

dry before starting.

Check the test expiry date 

indicated on the external 

packaging. Do not use if the 

expiry date has passed. (10)XXXXXXXXXX

(01)XXXXXXXXXXXXX

(11)YYMMDD

(17)YYMMDD

XXXXXXXXXXX / Sub : X

-Buer : XXXXXXXXXXX

YYYY.MM.DD.

YYYY.MM.DD.

X XXXXXX XXXXXX

NOTE: Testing should commence immediately after opening the sealed 

pouches.

2

3

4

5

5

Look at the result window and locate the letters C and T on the top side of the window. A colored line should always appear at the C position; this is the control line signals 

that the test is working properly.

10

WARNING! Inaccurate test interpretations may occur if results are read before 20 minutes or after 30 minutes.

◀ Positive result 

If the Control line (C) and the Test line (T) are visible, the test is 

positive. Any faint visible colored test (T) 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).

◀ Invalid result

If the control (C) line is not visible, the test is invalid. Re-test 

with a new swab and new test device.

C T

C T

C T

C T

C T

7

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.

NOTE: Report your test result. For more information on the mobile app, please scan 

the QR code on the next page.

Reporting helps public health teams understand COVID-19 spread in your area and 

across the country and informs public health decisions.

◀ Negative result

If the Control line (C) is visible, but the Test line (T) 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 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. 

Open foil pouch 1 by tearing along the tear-line. Remove the test device 

and desiccant package from the foil pouch. Place the test device on a flat 

surface.

Ensure that the test device is intact 

and that there are no green beads 

in the desiccant package (white and 

yellow beads are expected). Do not

open the desiccant package.

Open foil pouch 2 and place one tube 

and one nozzle cap on the table.

Tube Nozzle

cap

Open the seal of the tube carefully 

without spilling the liquid inside 

the tube. Place the tube in the tube 

holder.

If any liquid spills, do not use the 

tube.

Remove the swab from the packaging.

Ensure that you only touch the handle 

of the swab and not the soft pad at 

the tip.

1

2

Holding the stick end of the swab, gently insert the foam end of the swab 

into the nostril approximately 3⁄4 of an inch.

3

**Swab Both Nostrils**

Firmly and slowly rotate the swab at 

least 5 times, brushing against the 

inside walls of the nostril, for a total 

of 15 seconds. 

**Do not just spin the swab.** 

Gently remove the swab and, using 

the same swab, repeat in the second 

nostril with the same end of the 

swab.

NOTE: With children, the maximum 

depth of insertion into the nostril may 

be less than 3⁄4 of an inch, and you 

may need to have a second person to 

hold the child's head while swabbing. 

15sec

5x

15sec

15sec

5x

15sec

4

Insert the swab into the tube until the 

soft pad is in the liquid. Squeeze the 

tube at the bottom and hold it tight. 

Then stir the swab more than 10 

times.

This is to transfer the biological 

material from the swab to the liquid.

10x

Dispose of the swab and seal the 

tube securely with the nozzle cap.

Hold the tube upright above the sample well.

Drop 4 drops onto the sample well.

**Do not apply the liquid in the rectangular

result window**

Set the timer and read the test result at 20 minutes.

Do not read the result after 30 minutes.

Read

at 20 mins.

Do not read

after 30 mins.

WARNING! Do not move or lift the test device during this time.

NOTE: Dispose of the used test in the household trash.

Do not flush or pour test liquids down a drain.

Remove the swab while squeezing 

the sides of the tube to extract the 

liquid from the swab.

WARNING! Failure to squeeze the tube can lead to incorrect results 

due to excess buffer in the swab.

6

8

9

000012

4 drops
Healthcare Providers 

Please visit https://go.roche.com/COVID-Home-Test to obtain the complete instructions 

for use and fact sheet for healthcare providers.

Index of Symbols

Reference number In vitro Diagnostics

Batch code Consult Instructions for use

Manufacturer Do not use if package is damaged

Contains Sufficient for <n> Tests Date of manufacture

Use-by date Do not re-use

Caution Temperature limit

Keep dry Keep away from sunlight

For FDA Emergency Use Authorization (EUA) only.

• For more information on EUAs please visit: 

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatoryand-policy-framework/emergency-use-authorization

• For the most up to date information on COVID-19, please visit: 

www.cdc.gov/COVID19

• For detailed instructions, please visit: https://go.roche.com/COVID-Home-Test

Intended Use

The Pilot® COVID-19 At-Home 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 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. This test is authorized 

for individuals with symptoms of COVID-19 within the first 6 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.

This test can be performed with or without the supervision of a telehealth proctor.

The Pilot® COVID-19 At-Home Test does not differentiate between SARS-CoV and 

SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen which 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 

patient 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 Pilot® COVID-19 At-Home 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 

SARS-CoV-2 infection 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 from their physician or healthcare provider.

Individuals should provide all results obtained with this product to their healthcare 

provider for public health reporting and to receive appropriate medical care. 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 Pilot® COVID-19 At-Home Test is authorized for non-prescription self-use and/or as 

applicable, for an adult lay user testing another aged 2 years or older in a non-laboratory 

setting.

The Pilot® COVID-19 At-Home Test is only for use under the Food and Drug 

Administration’s Emergency Use Authorization. This product has not been FDA cleared or 

approved.

Warnings and Precautions

• 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 6 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 14 years 

and older. Children age 2 to 13 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.

• Use only the components of this test kit.

• Do not use kit past its expiration date.

• Do not open the kit contents until ready for use.

• Testing should commence immediately after opening the sealed pouches.

• Do not touch the swab tip.

• Do not read test results before 20 minutes or after 30 minutes. Results read before 

20 minutes or after 30 minutes may lead to a false positive, false negative, or invalid 

result.

• The control line may show up within a few minutes of starting the test. It may take up 

to 20 minutes for a test line to show up.

• Make sure there is sufficient light when testing

• Do not use nasal sprays for at least 30 minutes before collecting a nasal sample.

• In the event of a spillage, ensure it is cleaned thoroughly using a suitable disinfectant.

• If you suspect the presence of blood on the swab, discard the swab, make sure you 

are not bleeding, and repeat the test with a fresh swab.

• Remove any piercings from the nose before starting the test.

• Do not use on anyone who is prone to nosebleeds or has had facial injuries or head 

injuries/surgery in the past six months.

• 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 

reagent solution contains harmful chemicals (see table below).

Chemical Name 

/ CAS

Hazard Category 

(mixture)

Hazard Statement for 

Mixture

Labeling of 

Harm(s)

Sodium chloride / 

7647-14-5

L-Arginine / 74-79-3

Category 2 Eye irritation May cause eye 

irritation

Polidocanol / 

9002-92-0

ProClin® 300

Category 3 Skin irritation Causes mild skin 

irritation

• If the solution contacts your skin and eyes, flush with large amounts of water. 

If irritation persists, seek medical advice: https://www.poisonhelp.org or 

1-800-222-1222.

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 in December 2021 and February - March 

2022. 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 SARSCoV-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 COVID19, 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.

• The test should be used for the detection of SARS-CoV-2 antigen in human nasal 

swab samples.

• Incorrect test results may occur if a specimen is incorrectly collected or handled.

• This is a qualitative test, therefore quantitative values of SARS-CoV-2 antigen 

concentration cannot be determined.

• False negative test results (i.e., an existing infection is not detected) may occur if the 

antigen level in the specimen is less than the minimum detection limit of the test.

• False negative test results may occur if the specimen swab is not mixed well in the 

tube (step 5 in the test procedure section).

• The immune response cannot be evaluated using this test. Other test methods are 

required for that purpose.

• The test does not differentiate between SARS-CoV and SARS-CoV-2.

How to Use this Test

• 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.

Frequently Asked Questions

Q: WHAT ARE THE KNOWN POTENTIAL RISKS AND BENEFITS OF THIS TEST?

A: Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test results (see Warnings and Result Interpretation sections for 

more information).

Potential benefits include:

• The results, along with other information, can help you and your healthcare 

provider make informed decisions about your care.

• The results of this test may help limit the 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 

Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?

A: 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 

Pilot® COVID-19 At-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. 

Q: HOW ACCURATE IS THIS TEST?

A: 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 https://go.roche.com/COVID-Home-Test.

Q: WHAT IF I HAVE A POSITIVE TEST RESULT?

A: 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. 

Q: WHAT IF I HAVE A NEGATIVE TEST RESULT?

A: 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.

Q: WHAT DOES AN INVALID TEST RESULT MEAN?

A: 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 

you should test again with a new test.

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. 

More Information

For more information on the Pilot® COVID-19 At-Home 

Test, information on how to use the mobile application for 

recording and reporting test results, or to access a Spanish 

translation of the test instructions, scan this QR code or 

visit the website below.

https://go.roche.com/COVID-Home-Test 

If you have any questions about using the test or reading 

the results, please call US COVID-19 General Support 

1.866.987.6243

SD Biosensor, Inc.

Head office: C- 4th & 5th, 16, Deogyeongdaero 1556 beon-gil, Yeongtong-gu, Suwon-si, 

Gyeonggi-do, 16690, REPUBLIC of KOREA

Manufacturing site: 74, Osongsaengmyeong 

4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, 

Chungcheongbuk-do, 28161, REPUBLIC OF

KOREA

Distribution in USA by:

Roche Diagnostics, Indianapolis, IN

US COVID-19 General Support 

1.866.987.6243 

www.diagnostics.roche.com

L20SCR20EN02R5

Issue date: 2023.05

09635807001

V 6.0 Revision date: 2023.05

©2023. SD Biosensor All rights reserved.
EN

ES

SD BIOSENSOR 

Head office: C-4th & 5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu,

Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA

Manufacturing site: 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu

Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA,

www.sdbiosensor.com 

Distribution by:

Roche Diagnostics, Indianapolis, IN

www.diagnostics.roche.com

US COVID-19 General Support 1-866-987-6243

For in vitro diagnostic use only. Store between 36-86 °F (2-30 °C) until use. 

Contents: Test device x 1, Extraction buffer tube x 1, Nozzle cap x 1, Sterile swab x 1,

Tube holder x 1, Quick Reference Instructions (en) x 1.

Needed but not provided: Timer

Para uso diagnóstico in vitro exclusivamente. Conservar entre 36-86 °F (2-30 °C) hasta el uso.

Contenido: Casete de test x 1, tubo de tampón de extracción x 1, capuchón de aguja x 1, 

torunda estéril x 1, soporte para tubo x 1, Instrucciones de referencia rápida (en) x 1.

Requerido adicionalmente (no suministrado): Cronómetro

• The Pilot® COVID-19 At-Home Test is 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. This test is authorized for individuals with symptoms of COVID-19 within the first 6 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.

• 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.

• In the USA, this product has not been FDA cleared or approved; but has been authorized for use 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.

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.

• 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 uthorization 

is revoked sooner.

1 TEST

K I T

Rapid antigen test for ages 2 and up

For use under the FDA Emergency Use Authorization (EUA) only.

>> US COVID-19 General Support: 1-866-987-6243

Distribution by:

For symbol glossary, refer to Quick Reference Instructions.

For more information on expiration dating for COVID-19 antigen

tests, please refer to http://www.fda.gov/covid-tests.

QUICK RESULTS

In as few as 20 minutes 

EASY TO USE

With a simple nasal swab

TAKE CONTROL

Σ 1 IVD 30 °C

86 °F 2 °C

36 °F

Distribution by:

REF 9901-NCOV-10G

Cat No.:

99COV200-EN02

Roche order number:

09620702160

B01SCR20EN02R4

Issue date: 2023.01

09621954001(04)

COVID-19 At-Home Test COVID-19 At-Home Test

Test COVID-19 At-Home

For more information on the Pilot® COVID-19 At-Home 

Test, information on how to use the mobile application 

for recording and reporting test results, or to access a 

Spanish translation of the test instructions, scan this 

QR code or visit the website below.

Para más información sobre Pilot® COVID-19 At-Home 

Test, instrucciones de uso de la app del celular para 

registrar y reportar resultados del test o acceder a las 

instrucciones del test en español, escanee este código 

QR o visite el sitio web siguiente.

EN

ES

https://go.roche.com/COVID-Home-Test

The information provided using this QR Code is only intended to be general summary 

information to the public and is not intended to take the place of professional medical 

advice or treatment. Always seek the advice of your physician or other qualified 

health provider with any questions you may have regarding your health. The owner 

of www.covid19knowmore.com does not have any role in the design, manufacture or 

distribution of the Pilot® COVID-19 At-Home Test.

covid19knowmore.com 

to learn more about 

COVID-19 and 

treatment options

Scan or Visit 

Test Positive?

UDI Label

(with UPC)
Distribution by:

Roche Diagnostics, Indianapolis, IN

www.diagnostics.roche.com

US COVID-19 General Support 1-866-987-6243

TESTS

K I T

Cat No.: 99COV200L-EN02

Roche Order No.: 09666672160 

REF 9901-NCOV-10G

Distribution by: Distribution by:

4 TESTS

K I T

4 TESTS

K I T

Distribution by:

Rapid antigen test 

for ages 2 and up

For use under the FDA Emergency Use 

Authorization (EUA) only.

>> US COVID-19 General Support: 1-866-987-6243

For symbol glossary, refer to Quick Reference Instructions.

For more information on expiration dating for COVID-19

antigen tests, please refer to http://www.fda.gov/covid-tests.

QUICK RESULTS

In as few as 20 minutes

EASY TO USE

With a simple nasal swab

EN

ES

. y For in vitro diagnostic use onl

een 36-86 °F (2-30 °C) until use. w Store bet

ube holder x 1, T ab x 4, w est device x 4, Extraction buffer tube x 4, Nozzle cap x 4, Sterile s T Contents: 

vided: Timer o Quick Reference Instructions (en) x 1. Needed but not pr

Para uso diagnóstico in vitro exclusivamente.

var entre 36-86 °F (2-30 °C) hasta el uso. r Conse

Casete de test x 4, tubo de tampón de extracción x 4, capuchón de aguja x 4, torunda estéril x 4, Contenido: 

te para tubo x 1, Instrucciones de referencia rápida (en) x 1. Requerido adicionalmente (no suministrado): Cronómetro r sopo

individuals aged 14 years or older or adult collected anterior nasal COVID-19 At-Home Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from ® Pilot The •

wice over three days within the first 6 days of symptom onset when tested at least t is test is authorized for individuals with symptoms of COVID-19 (nares) swab samples from individuals aged 2 years or older. Th

48 hours between 9 when tested at least three times over five days with at least ut symptoms or other epidemiological reasons to suspect COVID-1 with at least 48 hours between tests, and for individuals witho

tests.

ting. This test is more likely to give you a false negative result when you have Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) tes •

COVID-19 than a lab-based molecular test.

A. U A under an E D ed; but has been authorized for use by F vo ppr A cleared or a D In the USA, this product has not been F •

. s thogen a -2, not for any other viruses or p V This product has been authorized only for the detection of proteins from SARS-Co •

. y e immunit va ou h y VID-19 in the past or if O ou had C y T determine if O This test does N •

ection and/or det tion of emergency use of in vitro diagnostics for a t circumstances exist justifying the authoriz a tion th a tion of the declar a The emergency use of this product is only authorized for the dur •

.r oked soone v tion is re a ted or authoriz a tion is termin a . § 360bbb-3(b)(1), unless the declar C. S. U ct, 21 A , and Cosmetic g VID-19 under Section 564(b)(1) of the Federal Food, Dru O diagnosis of C

SD BIOSENSOR

Head office: C-4th & 5th, 16, Deogyeong-daero

1556beon-gil, Yeongtong-gu, Suwon-si,

Gyeonggi-do, 16690, 

REPUBLIC OF KOREA

o, r- 4 eong y ngm eas ng o Os 4, 7: eit s ing r tu c anufa M

Osong-eup, Heungdeok-gu, Cheongju-si, 

Chungcheongbuk-do, 28161, 

REPUBLIC OF KOREA

www.sdbiosensor.com

TAKE CONTROL

COVID-19 At-Home Test

4 TESTS

K I T

Σ IVD 4

30 °C

86 °F 2 °C

36 °F

Test COVID-19 At-Home

09667199001(04)

B04SCR20LEN02R3

Issue date: 2023.01

ES

COVID-19 At-Home Test, ® Pilot For more information on the 

information on how to use the mobile application for recording and 

reporting test results, or to access a Spanish translation of the test 

instructions, scan this QR code or visit the website below.

COVID-19 At-Home Test, ® Pilot Para más información sobre 

instrucciones de uso de la app del celular para registrar y reportar 

resultados del test o acceder a las instrucciones del test en español, . escanee este código QR o visite el sitio web siguiente

https://go.roche.com/COVID-Home-Test 

1-866-987-6243 US COVID-19, General Support:

EN

covid19knowmore.com

to learn more about 

COVID-19 and 

treatment options

or Visit Scan 

Test Positive?

The information provided using this QR Code is only intended to be general summary 

information to the public and is not intended to take the place of professional medical 

advice or treatment. Always seek the advice of your physician or other qualified 

health provider with any questions you may have regarding your health. The owner 

of www.covid19knowmore.com does not have any role in the design, manufacture or 

 COVID-19 At-Home Test. ® distribution of the Pilot

UDI Label

(with UPC)
01(04) 096219890

B25SCR20DEN02R4 

Issue date: 2023.01

Distribution by: Distribution by: Distribution by: Distribution by:

 COVID-19 At-Home Test is authorized for Pilot® • The 

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. 

This test is authorized for individuals with symptoms of 

COVID-19 within the first 6 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.

• 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.

• In the USA, this product has not been FDA cleared 

or approved; but has been authorized for use 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.

• This test does NOT determine if you had COVID-19 in 

the past or if you have immunity.

• 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.

25 TESTS25 K I T

TESTS

K I T

REF ES EN

Cat No.: 99COV200D-EN02

Roche order number: 09620729160

9901-NCOV-10G

Distribution by:

25 TESTS

K I T

Rapid antigen test for ages 2 and up

For use under the FDA Emergency Use Authorization (EUA) only.

>> US COVID-19 General Support: 1-866-987-6243

For symbol glossary, refer to Quick Reference Instructions.

For more information on expiration dating for COVID-19 antigen tests, please refer to 

http://www.fda.gov/covid-tests.

QUICK RESULTS

In as few as 20 minutes

EASY TO USE

With a simple nasal swab

SD BIOSENSOR 

Head office: C-4th & 5th on-si, w eongtong-gu, Su Y eong-daero 1556beon-gil, y , 16, Deog

, 16690, REPUBLIC OF KOREA o eonggi-d y G

-gu k , Osong-eup, Heungdeo o eong 4-r y Manufacturing site: 74, Osongsaengm

, 28161, REPUBLIC OF KOREA, o -d k Cheongju-si, Chungcheongbu

.com r .sdbiosenso w ww

Distribution by:

, IN s , Indianapoli s Roche Diagnostic

.roche.com s .diagnostic w ww

US COVID-19 General Support 1-866-987-6243

. y For in vitro diagnostic use onl

een 36-86 °F (2-30 °C) until use. w Store bet

Contents:

1) Test device x 25

2) Extraction buffer tube x 25

3) Nozzle cap x 25

4) Sterile swab x 25

5) Tube holder x 5

6) Quick Reference Instructions (en) x 5

Needed but not provided: Timer

Para uso diagnóstico in vitro exclusivamente.

Conservar entre 36-86 °F (2-30 °C) hasta el uso.

Contenido:

1) Casete de test x 25

2) Tubo de tampón de extracción x 25

3) Capuchon de aguja x 25

4) Torunda estériles x 25

5) Soporte para tubos x 5

6) Instrucciones de referencia rápida (en) x 5

Requerido adicionalmente (no suministrado): 

Cronómetro

TAKE CONTROL

COVID-19 At-Home Test

Σ IVD 25

30 °C

86 °F 2 °C

36 °F

ES

 COVID-19 At-Home Test, ® Pilot For more information on the 

information on how to use the mobile application for recording 

and reporting test results, or to access a Spanish translation of 

the test instructions, scan this QR code or visit the website below.

 COVID-19 At-Home Test, ® Pilot Para más información sobre 

instrucciones de uso de la app del celular para registrar y reportar 

resultados del test o acceder a las instrucciones del test en español, 

escanee este código QR o visite el sitio web siguiente.

https://go.roche.com/COVID-Home-Test 

US COVID-19, General Support: 1-866-987-6243

 COVID-19 At-Home Test, ® Pilot For more information on the 

information on how to use the mobile application for recording 

and reporting test results, or to access a Spanish translation of 

the test instructions, scan this QR code or visit the website below.

 COVID-19 At-Home Test, ® Pilot Para más información sobre 

instrucciones de uso de la app del celular para registrar y reportar 

resultados del test o acceder a las instrucciones del test en español, 

escanee este código QR o visite el sitio web siguiente.

https://go.roche.com/COVID-Home-Test 

US COVID-19, General Support: 1-866-987-6243

EN EN

ES

Test COVID-19 At-Home Test COVID-19 At-Home Test COVID-19 At-Home Test COVID-19 At-Home

covid19knowmore.com

to learn more about 

COVID-19 and 

treatment options

or Visit Scan 

Test Positive?

The information provided using this QR Code is only intended to be general summary 

information to the public and is not intended to take the place of professional medical 

advice or treatment. Always seek the advice of your physician or other qualified 

health provider with any questions you may have regarding your health. The owner 

of www.covid19knowmore.com does not have any role in the design, manufacture or 

 COVID-19 At-Home Test. ® distribution of the Pilot

UDI Label

(with UPC)
D

O

N

OT OPEN UNTIL INSTRUCTED

PILOT ® COVID-19 AT-HOME TEST

1 TEST / KIT

Pilot® COVID-19 At-Home Test

For more information on thePilot®COVID-19

At-Home Test, please visit thewebsite provided below.

© 2023 eMedTM All rights reserved.

The products of eMed 

are protected by patents.

https://go.roche.com/COVID-Home-Test

US COVID-19 General Support:

1-866-987-6243

REF 9901-NCOV-10G

Cat No.: 99COV230-EN02

Roche order number:

For more information on expiration 

dating for COVID-19 antigen tests, 

please refer to

http://www.fda.gov/covid-tests.

09780076001

B01SCR23EN02R1 

Issue date: 2023.01

09748997001(02)

i

®

tions

For in vitro diagnostic use only. For Ages 2 & up. Store between 36-86 °F (2-30 °C) until use. 

Contents: Test device x 1, Extraction buffer tube x 1, Nozzle cap x 1, Sterile swab x 1,

Tube holder x 1, Quick Reference Instructions x 1. 

Needed but not provided: Timer, Internet enabled device with audio and video capabilities

Pilot COVID-19 At-Home Test

For symbol glossary, refer to Qu ck Reference Instruc .

DISTRIBUTION BY 30 °C

86 °F 2 °C

36 °F IVD 1

Pilot® COVID-19 At-Home Test

SD BIOSENSOR 

Head office: C-4th & 5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, 

Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA

Manufacturing site: 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, 

Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA

www.sdbiosensor.com 

Distribution by:

Roche Diagnostics, Indianapolis, IN, www.diagnostics.roche.com

US COVID-19 General Support 1-866-987-6243

eMed.com

DISTRIBUTION BY

• The Pilot® COVID-19 At-Home Test is 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. This test is authorized for individuals with symptoms of COVID-19 within the first 6 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.

• 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.

• In the USA, this product has not been FDA cleared or approved; but has been authorized for use 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.

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.

• 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.

ID: B-AAB

Using a Computer?

Visit eMed.com

UDI label

(with UPC)

eMED Telehealth - Covid Test - US - 122 x 72 x 26 mm