REMOVE SWAB FROM TUBE

After 1 minute take the tube out of the tube holder.

As you remove the swab from the tube, squeeze swab tip several times

from outside of the tube. Try to release as much liquid from the swab 

as possible. Dispose the swab in the trash.

INSERT TIP

Take a tube tip from the kit and push it into the top of the tube. 

Make sure there is a tight fit.

15 minutes

1 minute

INTRODUCTION

IMPORTANT

- Read instructions carefully before starting the test.

- For non-prescription home use with self-collected anterior nasal swab samples from 

individuals aged 14 years or older, or adult-collected anterior nasal swab samples 

from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 

days of symptom onset for serial testing for use at least twice over three days with at 

least 48 hours between tests.

Also for non-prescription home use with self-collected anterior nasal swab samples 

from individuals aged 14 years or older, or adult-collected anterior nasal swab 

samples from individuals aged 2 years or older, without symptoms or other 

epidemiological reasons to suspect COVID-19 for serial testing for use at least three 

times over five days with at least 48 hours between tests.

- Test setup is about 5 minutes. The result must be read at 15 minutes.

- All test materials must be at room temperature before use.

- You should wear a face mask if swabbing others.

- You must follow the test directions carefully to get an accurate result.

- Visit https://labtest.recurohealth.com/signup/CLINITEST to access the optional 

Recuro Health web app, using a compatible mobile phone (Requires modern mobile 

web browser, e.g. Chrome, Safari). The App includes access to video instructions, test 

timers, help with results interpretation and test reporting features. If you have any 

questions about using the test or reading the results please call our customer care 

hotline.

Telephone: 1-833-933-2340

E-Mail: covidhometest-USA.dl@siemens-healthineers.com

https://www.clinitest.siemens-healthineers.com/us

WASH HANDS

Wash your hands with soap and water for 30 seconds or use hand sanitizer.

Make sure hands are dry before starting.

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.

GATHER MATERIALS

Check expiration date of the test kit before use. Expiration date is printed 

on the box and each test pouch. Do not use if test is expired.

TUBE

TIP

TUBE HOLDER

CLINITEST®

Rapid COVID-19 Antigen Test

TEST DEVICE POUCH

STERILE SWAB

TIMER (not included)

STEP 1.

PLACE TUBE IN TUBE HOLDER

Find tube holder shown on the back of the box. 

Push tube through outlined hole. 

STEP 2.

OPEN TUBE

Remove the seal from the tube. Avoid spilling the liquid.

Make sure the tube is standing up straight. 

STEP 3.

OPEN SWAB

Open the swab pouch on the end opposite the swab tip by peeling back the 

pouch cover. Hold the plastic stick end of the swab and remove from pouch. 

Be careful not to touch the tip of the swab. 

SWAB BOTH NOSTRILS

Carefully insert swab tip into one nostril about 1/2 to 3/4 of an inch deep. 

Do not insert the swab any further if you feel any resistance. Rub the 

insides of the nostril in a complete circle at least 5 times. Make sure that 

you are rubbing the insides of the nostril. Take approximately 15 seconds 

to collect the specimen. Be sure to collect any nasal drainage that may be 

present on the swab Remove swab from the nostril and 

repeat in your other nostril.

NOTE: If you are swabbing others, please wear a face mask. With 

children, you may not need to insert the swab as far into the nostril. 

For very young children, you may need another person to steady the 

child's head while swabbing. 

NOTE: Failure to swab properly may cause false negative results.

5 circles 5 circles

STEP 4.

PLACE SWAB IN TUBE

Remove the swab from your nostril. Immediately take the tube out of 

the tube holder and insert swab tip into the liquid inside the tube. 

Mix vigorously by rolling the swab tip at least 6 times on the bottom 

and sides of the tube.

6 circles

PLACE TUBE IN TUBE HOLDER

Place the tube back into the tube holder. Keep the swab inside of the tube.

Start timer for 1 minute.

STEP 5.

OPEN TEST DEVICE

Open the test device pouch by tearing the area circled below. 

Place the test device on a flat surface.

CLINITEST®

Rapid COVID-19 Antigen Test

CLINITEST®

Rapid COVID-19 Antigen Test

Result 

window

Sample 

ADD 4 DROPS well

Hold the tube straight up and down above the test device and gently 

squeeze to add 4 drops of solution into the sample well, labeled as “S” 

on the test device. Adding more or less than 4 drops of solution into 

the sample well may result in incorrect results.

START TIMER

Start timer for 15 minutes. 

Do not move the test device. Keep on a flat surface. 

STEP 6.

READ TEST RESULT

After 15 minutes find result window, labeled as “C” (for Control) and “T” 

(for Test) on the test device. It is important to read your test result at 

15-20 minutes. False negative or false positive results can occur if test 

results are read before 15 minutes or after 30 minutes. Repeat testing is 

needed to improve test accuracy. Please follow the table below when

interpreting test results 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.

COVID-19 POSITIVE

If the test device looks like the examples below, then protein from the 

virus that causes COVID-19 was detected in the sample. The test is 

positive if there are two pink/red lines present, one at the Control "C" 

line and one at the Test "T" line. Look very closely for line next to "T". 

This line can be very faint. Any visible pink/red "T" line is a positive 

result when the "C" line is also present.

IF THE TEST IS 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).

COVID-19 NEGATIVE

If the test device looks like the example below then protein from the 

virus that causes COVID-19 was not detected. You will only see 

one line next to “C” and there will not be any line visible next to"T".

IF 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.

INVALID

If the test device looks like the examples below then the test was not 

able to give a result and you must repeat the test with a new swab, 

a new tube, and a new test device. The test is INVALID if there is no 

line next to "C".

IF THE TEST IS INVALID

If at 15 minutes the line next to the “C” does not appear, even if any 

shade of pink/red “T” line appears, the test result is invalid. If the test 

result is invalid, a new swab should be collected, and the test should 

be performed again with a new tube and test device.

QUICK REFERENCE INSTRUCTIONS

CLINITEST®

RAPID COVID-19 ANTIGEN SELF-TEST

For Emergency Use Authorization (EUA) Only.

In vitro diagnostic use only.

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.

PAGE 1 

PREP

Remove all contents in the box. Read instructions.

Do not start Step 1 until you are ready to begin the test. 

Status on

First Day of Testing

With

Symptoms

Positive for

COVID-19

Positive for

COVID-19

Positive for

COVID-19

Positive for

COVID-19

Positive for

COVID-19

Negative for

COVID-19

Negative for

COVID-19

Positive N/A N/A

Positive N/A N/A

Negative Positive N/A

Negative Positive N/A

Negative Negative N/A

Negative Negative Positive

Negative Negative Negative

Without

Symptoms

First Result

Day 1

Second Result

Day 3

Third Result

Day 5 Interpretation

Below are examples for positive, negative and invalid test results. 

Used test materials should be thrown away as household waste.
FOR FDA EMERGENCY USE AUTHORIZATION (EUA) ONLY

• For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-

 response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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

• For detailed instructions, please visit: https://www.clinitest.siemens-healthineers.com/us

• For the most current expiration dates of this test, please refer to: https://www.fda.gov/covid-tests.

INTENDED USE

The CLINITEST® Rapid COVID-19 Antigen Self-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 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 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 CLINITEST® Rapid COVID-19 Antigen Self-Test does not differentiate between SARS-CoV or SARSCoV-2. 

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal 

(nares) samples 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 and the agent detected may not be the definitive cause of 

disease. Individuals who test positive with the CLINITEST® Rapid COVID-19 Antigen Self-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 with 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 SARSCoV-2 Tests provided by CDC. 

The CLINITEST® Rapid COVID-19 Antigen Self-Test is intended for non-prescription self-use and/or, as applicable, for an adult 

lay user testing another aged 2 years or older. The CLINITEST® Rapid COVID-19 Antigen 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.

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION

Read the CLINITEST® Rapid COVID-19 Antigen Self-Test Package Insert carefully before performing a test. Failure to follow 

directions may produce inaccurate test results.

• Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate 

test results.

• 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.

• The Test is intended to aid in the diagnosis of a current COVID-19 infection. Please consult a healthcare professional to

discuss your results and if any additional testing is required.

• Keep test kit and materials out of the reach of children and pets before and after use.

• Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.

• This test is read visually. Users with impaired vision or color-impaired vision may not be able to read the test.

• 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.

• The control line may show up within a few minutes of starting the test. It may take up to 15 minutes for a test line to

show up.

• Do not use on anyone under two years of age.

• Do not open the kit contents until ready for use. If the test cassette is open for an hour or longer, invalid test results may occur.

• Do not use the test after the expiration date shown on the kit box.

• Do not use if any of the test kit contents or packaging is damaged or open.

• Test components are single-use. Do not re-use.

• Make sure there is sufficient light when testing. For best results, read test in a well-lit area.

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

• 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.

• Inadequate or improper nasal swab sample collection may yield false negative test results.

• Do not touch the swab tip (specimen collection area) when handling the swab.

• Once opened, the test card should be used within 60 minutes.

• The test is intended to be read at 15 minutes. If the test is read before 15 minutes or after 30 minutes, false negative or

false positive results may occur, and the test should be repeated with a new test cassette.

• Do not ingest any kit components.

• Avoid exposure of your skin, eyes, nose, or mouth to the solution in the tube.

• The solution in the tube and the test device contains an ingredient that is hazardous to skin and eyes (see table below). 

If contact with the body occurs, rinse with 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

between November 2021 – February 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 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.

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 Result Interpretation section).

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/emergency-preparedness-andresponse/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 virus that causes COVID-19. Molecular tests detect genetic material from the virus. 

Antigen tests, such as the CLINITEST® Rapid COVID-19 Antigen Self-Test, detect proteins from the virus. Antigen tests are 

very specific for the SARS-CoV-2 virus but are not as sensitive as molecular tests. 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://www.clinitest.siemens-healthineers.com/us.

Q: WHAT IF YOU TEST POSITIVE?

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 YOU TEST NEGATIVE?

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: If no control line shows up on the test, the result is invalid (even if any test line shows up). An invalid result means the test 

was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal 

specimen and the test should be run again, using a new test and tube.

Address: 3818 Fuqua Street, Houston, TX 77047, USA.

Tel: +1 713-733-8088 Fax: +1 713-733-8848

Website: www.healgen.com

Manufacturer Date of manufacture

Catalogue number

In vitro diagnostic medical device Use-by date

Consult instructions for use Batch code

Temperature limit Do not reuse

Index of Symbols

Revision Date: 2023-02, B22347-04 Rev. D

PAGE 2 

IMPORTANT

This test is intended to be used as an aid in the clinical diagnosis of a current COVID-19 infection. Do not use this test as the 

only guide to manage your illness. Please consult your healthcare provider if your symptoms persist or become more severe, 

or if you are concerned at any time.

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting.

HEALTHCARE PROVIDERS

Please visit https://www.clinitest.siemens-healthineers.com/us to obtain the complete instructions for use and fact sheet for 

healthcare providers.

Chemical Name/CAS GHS Code for applicable 

Ingredient

Concentration

(%)

Sodium Azide/26628-22-8 Acute Tox. 2 (Oral), H300

Acute Tox. 1 (Dermal), H310

0.02% (device) 

and 0.05%

(tube)

Triton/9002-93-1 Acute Tox. 4 (Oral), H302 1.5%
1

GCCOV-502a-H1US

(11561587)

2°C

30°C

Distributed by Siemens Healthineers

00816490025733

B01598-01

Contents of the kit:

1 Test Device

1 Sterile Swab

1 Extraction Tube with Buffer and Tip

Instructions for Use

*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.

Insert tube here

Inserte el tubo aquí

www.clinitest.siemens-healthineers.com/us

Rapid COVID-19 Antigen Self-Test

CLINITEST®

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.

The CLINITEST® Rapid COVID-19 Antigen Self-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 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 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.

Visit https://labtest.recurohealth.com/signup/CLINITEST to access the optional Recuro Health web app, 

using a compatible mobile phone (Requires modern mobile web browser, e.g. Chrome, Safari). The App 

includes access to video instructions, test timers, help with results interpretation and test reporting 

features.

For in vitro diagnostic use.

For Emergency Use Authorization (EUA) only. 

This test can be used at home on people aged 2 years old and up.

Items necessary to use the kit, but not provided:

- Timer

For Symbol Glossary, refer to Instructions for Use.

For the most current expiration dates of this test, please refer to: https://www.fda.gov/covid-tests.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens in 15 minutes.
2

GCCOV-502a-H2US

(11561908)

2°C

30°C

Distributed by Siemens Healthineers

00816490025979

B01638-01

Contents of the kit:

2 Test Devices

2 Sterile Swabs

2 Extraction Tubes with Buffer and Tips

Instructions for Use

Insert tube here

Inserte el tubo aquí

www.clinitest.siemens-healthineers.com/us

Rapid COVID-19 Antigen Self-Test

CLINITEST®

*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.

For in vitro diagnostic use.

For Emergency Use Authorization (EUA) only. 

This test can be used at home on people aged 2 years old and up.

Items necessary to use the kit, but not provided:

- Timer

For Symbol Glossary, refer to Instructions for Use.

For the most current expiration dates of this test, please refer to: https://www.fda.gov/covid-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.

The CLINITEST® Rapid COVID-19 Antigen Self-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 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 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.

Visit https://labtest.recurohealth.com/signup/CLINITEST to access the optional Recuro Health web app, 

using a compatible mobile phone (Requires modern mobile web browser, e.g. Chrome, Safari). The App 

includes access to video instructions, test timers, help with results interpretation and test reporting 

features.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens in 15 minutes.
2°C

30°C

4

GCCOV-502a-H4US

(11561910)

Distributed by Siemens Healthineers

00816490025948

Rapid COVID-19 Antigen Self-Test

B01639-02

Contents of the kit:

4 Test Devices

4 Sterile Swabs

4 Extraction Tubes with Buffer and Tips

Instructions for Use

 

Insert tube here

Inserte el tubo aquí

Insert tube here

Inserte el tubo aquí

*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.

For the most current expiration dates of this test, please refer to: https://www.fda.gov/covid-tests. www.clinitest.siemens-healthineers.com/us

CLINITEST®

For in vitro diagnostic use.

For Emergency Use Authorization (EUA) only. 

This test can be used at home on people aged 2 years old and up.

Items necessary to use the kit, but not provided:

- Timer

For Symbol Glossary, refer to Instructions for Use.

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.

The CLINITEST® Rapid COVID-19 Antigen Self-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 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 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.

Visit https://labtest.recurohealth.com/signup/CLINITEST to access the optional Recuro Health web app, 

using a compatible mobile phone (Requires modern mobile web browser, e.g. Chrome, Safari). The App 

includes access to video instructions, test timers, help with results interpretation and test reporting 

features.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens in 15 minutes.

200 mm x 70 mm x 32 mm
2°C

30°C

5

GCCOV-502a-H5US

(11556712)

Distributed by Siemens Healthineers

00816490025740

Rapid COVID-19 Antigen Self-Test

B01601-02

Contents of the kit:

5 Test Devices

5 Sterile Swabs

5 Extraction Tubes with Buffer and Tips

Instructions for Use

 

Insert tube here

Inserte el tubo aquí

Insert tube here

Inserte el tubo aquí

www.clinitest.siemens-healthineers.com/us

CLINITEST®

*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.

For in vitro diagnostic use.

For Emergency Use Authorization (EUA) only. 

This test can be used at home on people aged 2 years old and up.

Items necessary to use the kit, but not provided:

- Timer

For Symbol Glossary, refer to Instructions for Use.

For the most current expiration dates of this test, please refer to: https://www.fda.gov/covid-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.

The CLINITEST® Rapid COVID-19 Antigen Self-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 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 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.

Visit https://labtest.recurohealth.com/signup/CLINITEST to access the optional Recuro Health web app, 

using a compatible mobile phone (Requires modern mobile web browser, e.g. Chrome, Safari). The App 

includes access to video instructions, test timers, help with results interpretation and test reporting 

features.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens in 15 minutes.