EN

GENABIO

User Instructions

Genabio COVID-19 Rapid Self-Test Kit

A rapid test for the detection of SARS-CoV-2 antigens in 

anterior nasal swab specimens. For self-testing use. For 

use under an Emergency Use Authorization (EUA) only. 

Carefully read the instructions before performing the test. 

Failure to follow the instructions may result in inaccurate 

test results.

If you have any questions regarding the use of this 

product or if you want to report a test system problem, 

please contact Genabio DiagnosticsInc. (via Email: 

info@genabio.com, or via Phone: 1-800-614-3365. Test 

system problems may also be reported to the FDA 

through the MedWatch medical products reporting 

program (Phone: 800.FDA.1088; Fax: 800.FDA.0178; 

http://www.fda.gov/medwatch).

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 resultsshould be tested 

again after 48 hours. Individuals withoutsymptoms 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 teststo 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.

Step by Step Instructions

Prepare Materials

Open the package and take out the COVID-19 Test Pouch, 

Pre-filled Tube, Anterior Nasal Swab, and the Instruction 

for Use.

If stored refrigerated, allow test components 

(COVID-19 Test Pouch and Pre-Filled Tube) to equilibrate to 

room temperature (15‒30°C or 59-86°F ) before starting 

the Test Procedure.

COVID-19 Test Pouch

Genabio Rapid Test

Pre-Filled Tube

Anterior Nasal Swab Instruction for Use

Note: This product comesin a 1-test, 2-test, 5-test, or 25-test

configuration.

The number of itemssupplied in the kit will vary depending on 

which kit was purchased.

A timerisrequired to perform the test and is notincluded in 

the test kit. Do not begin if you do not have atleast 25 minutes 

available to focus on performing the test. Before you begin, 

wash your handsfor atleast 20 seconds and then dry your 

hands. Perform the test indoors, atroom temperature on a 

clean, flatsurface.

Preparation

Clean your handsthoroughly with hand sanitizer or 

soap for at least 20 seconds and make sure they are dry 

before you start the test.

Read the instructions.

.

.

Check the kit's contents and the expiration date. 

Genabio Rapid Test

Open the foil pouch and put the COVID-19 test cassette on a flat 

surface. Once opened, use the test cassette within 1 hour.

Specimen Collection

An anterior nasal swab sample can be self-collected by 

adults. Children 2-13 years old should be tested by an 

adult.

Remove the swab from the package.

Note: Do not touch the soft end with your hands or 

anything else.

Insert the entire soft end of the swab into your nostril 

no more than 3⁄4 of an inch (1.5 cm) into your nose. 

For children the maximum depth of insertion of swabs 

into the nostril may be less than 3⁄4 of an inch. You may 

need additional help from the other person to hold the 

child’s head for swab sampling.

Slowly rotate the swab, gently pressing against the 

inside of your nostril 10 times for a total of 15 seconds. 

Get as much nasal discharge as possible on the soft end 

of the swab. 

Gently remove the swab, use the SAME SWAB and 

repeat steps in your other nostril with the SAME end of 

the swab.

Be sure to collect nasal drainage on the swab. 

Note: Failure to swab properly may cause a false 

negative result.

Test Procedure

Tear off the seal on top of the collection tube.

Place the swab into the collection tube 

immediately and stir for 30 seconds.

Note: If the swab is not stirred at least 30 seconds, a 

false negative result may occur.

Rotate the swab at least 5 times 

while squeezing the tube.

Note: If the swab is not rotated at 

least 5 times, a false negative result 

may occur.

Remove the swab while 

squeezing the tube.

Attach the dropper tip firmly onto the tube.

3 drops

Invert the collection tube with sample, squeeze and 

add 3 drops to the sample well of the test cassette. 

RESULTS

Start the timer for 15 minutes. Do not move the cassette. 

Warning: Do not read the result before 15 minutes or after 30 

minutes. Inaccurate test results may occur if not interpreted in 

this time frame.

Result Interpretation

Repeat testing is needed to improve test accuracy. Please follow 

the table below when interpreting testresults for COVID-19.

Status on First 

Day of Testing 

First Result 

Day 1 

Second Result 

Day 3 

Third Result 

Day 5 

Interpretation 

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

With 

Symptoms 

Negative Positive N/A Positive for COVID-19 

Negative Negative N/A Negative for COVID-19 

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

Without 

Symptoms 

Negative Positive N/A Positive for COVID-19 

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.

Control (C) line and Test (T) line both appear as pink-colored lines in the 

show window.

Note: Any faint visible pink color Test (T) line should be interpreted as 

positive, when the Control (C) line is also present. The Test (T) line may 

vary in shade an intensity (light or dark, weak or strong) depending on the 

concentration of antigen present in the sample. The intensity of the 

Control (C) line should not be compared to that of the Test (T)line for 

interpretation ofthe test result. 

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 isincorrect (a false positive). Your healthcare provider will work 

with you to determine how best to care for you based on yourtest results 

along with medical history and your symptoms.

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

If no line appears in the Control (C) area, the test results are invalid 

regardless of the presence or absence of a line in the Test (T) area. An invalid 

result means the test was not able to tell if you have COVID-19 or not. If the 

test is invalid, re-test with a new swab and new test device.

Report your test result(s) at Genabio.com/covid under "Report Test Results" – 

this voluntary reporting helps public health teams understand COVID-19 

spread in your area and across the country and informs public health decisions.
EN

GENABIO

For Emergency Use Authorization (EUA) Only

For In Vitro Diagnostic Use

This product has not been FDA cleared or approved but has been 

authorized 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.

• 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 emergency use of this product is only authorized for the

duration of the declaration that circumstances exist justifying the 

authorization of emergency use of IVDs 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 detailed instructions, please visit:

https://www.genabio.com

Intended Use

The Genabio COVID-19 Rapid Self-Test Kit 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 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 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 Genabio COVID-19 Rapid Self-Test Kit does not differentiate 

between SARS-CoV or SARS-CoV-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 Genabio COVID-19 Rapid 

Self-Test Kit 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 allresults 

obtained with this productto their healthcare provider for public health 

reporting and to receive appropriate medical care. All healthcare providers will 

report alltestresults they receive from individuals who use the authorized 

product to relevant public health authorities in accordance with local,state, 

and federalrequirements 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 Genabio COVID-19 Rapid Self-Test Kitis intended for non-prescription selfuse and/or, as applicable, for an adult lay user testing another person aged 2 

years or older in a non-laboratory setting.

The Genabio COVID-19 Rapid Self-Test Kitis 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.

Warning and Precaution

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

approved but, has been authorized 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.

• 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. 

• Read all instructions carefully before performing the test. Failure 

to follow directions may product 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.

• Do not touch swab tip.

• Testing should occur immediately after opening the pouch.

• To ensure correct results, you must follow the instructions for use

• Use only the contents provided in the test kit.

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

• Do not use this test kit beyond its expiration date.

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

or open.

• Do not use the test on children under 2 years of age.

• An anterior nasal swab sample can be self-collected by an 

individual age 14 years and children aged 2 to 13 years of age should be 

tested by an adult.

• Wear a face mask or other face covering when collecting 

specimen from a child or another individual.

• False negative test results may occur if a specimen is incorrectly 

collected or handled.

• Do not read the test result before 15 minutes or after 30 

minutes. Results read before 15 minutes or after 30 minutes may lead 

to a false positive, false negative, or invalid result. 

• Once opened, the test card should be used with 30 minutes. 

• Keep testing kit and kit components away from children and 

pets before and after use. The chemicals in the reagent solution may be 

hazardous to the skin, eyes, nose, or mouth. Do not ingest any kit

components. The reagent solution contains harmful chemicals (see 

table blow). If the solution contacts your skin, eyes, nose, or mouth, 

flush with large 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/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization

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

https://www.cdc.gov/COVID-19

• Ensure that there is sufficient lighting for testing and interpretation.

Chemical Concentrations GHS Code for applicable Ingredient Name W/W %

Harmful if swallowed(H302) 

Triton X-100 Cause skin irritation(H315) 0.10%

Cause serious eye damage(H318)

Harmful if swallowed (H302)

Harmful if inhaled (H332) ProClin®300 0.05% Causes severe skin burns and eye damage (H314)

May cause an allergic skin reaction(H317)

Limitation

• Incorrect test results may occur if a specimen is incorrectly 

collected or handled.

• There is a higher chance of false negative results with home use 

tests than with laboratory-based molecular tests due to the sensitivity o

the test technology. This means that there is a higher chance this test 

will give you a negative result when you have COVID-19 as compared to 

molecular test, especially in samples with low viral load.

• All COVID-19 antigen test negative results are presumptive and 

confirmation with a molecular assay may be necessary. If you continue t

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.

• These test results are shown as lines of color. Because these lines

can be very faint, users with vision impairment - such as far-sightedness 

or glaucoma - are encouraged to seek assistance to interpret results 

accurately (e.g., reading glasses, additional light source, or another 

person with no vision impairment).

f 

a 

o 

• The performance of this test was established based on the 

evaluation of a limited number of clinical specimens collected between 

January 2022 and June 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.

Frequently Asked Questions

Q: WHAT IS COVID-19?

A: COVID-19 is an acute respiratory infectious disease caused by the 

SARS-CoV-2 virus, a novel Betacoronavirus. SARS-CoV-2 is mostly 

spread person-to-person, both by individuals with symptoms of 

COVID-19 infection and by infected people without symptoms. Based 

on the current knowledge, the incubation period is 1 to 14 days,

mostly 4-5 days. Symptoms include fever, fatigue, and cough. For a full 

list ofsymptoms, see: 

https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

Q: WHAT ARE THE KNOWN AND POTENTIAL RISKS 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. 

Q: WILL THIS TEST HURT?

A: No, the nasal swab is not sharp and it should not hurt. Sometimes the 

swab can feel slightly uncomfortable or tickly. If you feel pain, please stop 

the test and seek advice from a healthcare provider.

Q: WHAT IS SERIAL TESTING?

A: Serial testing is when one person tests themselves multiple times for 

COVID-19 on a routine basis, such as every day or every other day. By

.

testing more frequently, you may detect COVID-19 more quickly and 

reduce spread of infection. Serial testing (i.e. testing every day or 

every other day) is more likely to detect COVID-19. If you do not have 

any symptoms, testing should be performed at least twice over three 

days, with at least 24 hours and no more than 48 hours between tests. 

You may need to purchase additional tests to perform this serial 

(repeat) testing.

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.genabio.com.

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 self-isolate from others and contact 

a healthcare provider for medical advice about your positive result. 

Your healthcare provider will work with you to determine how best to 

care for you based on your test result, medical history, and symptoms.

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: 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 all new test components.

Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND 

MOLECULAR TEST?

A: There are different kinds of tests for the SARS-CoV-2virus that 

causes COVID-19. Molecular tests detect genetic material from the 

virus. Antigen tests such as the Genabio COVID-19 Rapid Self-Test Kit, 

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: IS THERE OTHER INFORMATION AVAILABLE DESCRIBING THE 

PERFORMANCE OF THIS TEST?

A: Yes. Please see the Healthcare Provider Instructions for Use 

available at https://www.genabio.com for additional information. The 

performance of this test is still being studied in patients without signs

and symptoms of respiratory infection and for serial screening. 

Performance may differ in these populations.

Important

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.genabio.com to obtain the complete instructions for 

use and fact sheet for healthcare providers.

Storage and Stability

Store the Genabio COVID-19 Rapid Self-Test Kit between 2-30 ° C 

(36-86 °F). Ensure that all kit contents are at room temperature 

before use. Kit contents are stable until the expiration date printed 

on the outer packaging. Do not use beyond the expiration date. 

The Test Cassette must remain in the sealed pouch until use.

For the most current expiration dates of this test, please refer to: 

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

Symbols

Catalogue number

In vitro diagnostic 

use only

Lot Number (Batch Code) Tests Per Kit

Use by (Expiration Date) Manufacturer

Temperature 

Limitations (Storage 

Temperature)

Date of Manufacture

One Time Use 

(Single Use Only)

Consult Instructions 

for Use

The extraction buffer solution in the extraction buffer tube contains a 

hazardous ingredient as shown in above table. If the extraction 

buffer solution contacts the skin or eye, immediately wash with plenty of 

running water. In case the irritation persists, please seek medical advice at: 

https://www.poison.org/contact-us or 1-800-222-1222.

In the USA

1. This test is intended to be used as an aid to clinical diagnosis of a current 

COVID-19 infection. Do not use this test as the only guide to manage your 

illness. 

2. In USA - This product has not been FDA cleared or approved but has been 

authorized by FDA under an Emergency Use Authorization (EUA). This 

product has been authorized only for the detection of proteins from SARSCoV-2, not for any other virus 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 

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.

Manufactured for Genabio Diagnostics Inc.

Add: 19B Crosby Dr. Ste220,Bedford,MA 01730,USA 

Tel: 1-800-614-3365

Email: info@genabio.com https://www.genabio.com

More Information:

All rights reserved.

All trademarks referenced are trademarks of either 

the Genabio of companies or their respective 

owners. GBD210613 Rev 7, Effective April 2023
The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic 

immunoassay device intended for the qualitative detection of the nucleocapsid protein 

antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals 

with or without symptoms or other epidemiological reasons to suspect COVID-19. 

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.

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

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

x For in vitro diagnostic use.

• For Emergency Use Authorization (EUA) only.

• For ages 2 through 13, an adult must collect and test the anterior nares specimen.

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

• For symptomatic individuals, the test is for serial testing at least twice over three days 

with at least 48 hours between tests.

• For asymptomatic individuals,the test is for serial testing at least three times over five 

days with at least 48 hours between tests.

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

authorized 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.

• 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.
In vitro diagnostic medical device 

• For in vitro diagnostic use. • For Emergency Use Authorization (EUA) only. • For ages 2 through 13, an adult must collect and test the anterior nares specimen. • This test does NOT determine if you had COVID-19 in the past or if you have immunity. • For symptomatic individuals, the test is for serial testing at least twice over three days with at 

least 48 hours between tests.

• For asymptomatic individuals,the test is for serial testing at least three times over five days 

with at least 48 hours between tests.

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

authorized 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.

• 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.

The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic immunoassay 

device intended for the qualitative detection of the nucleocapsid protein antigen from 

SARS-CoV-2 in anterior nasal swab specimens directly from individuals with or without 

symptoms or other epidemiological reasons to suspect COVID-19. 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.

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

http://www.fda.gov/covid-tests
The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic immunoassay 

device intended for the qualitative detection of the nucleocapsid protein antigen from 

SARS-CoV-2 in anterior nasal swab specimens directly from individuals with or without 

symptoms or other epidemiological reasons to suspect COVID-19. 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.

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

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

• For in vitro diagnostic use.

• For Emergency Use Authorization (EUA) only.

• For ages 2 through 13, an adult must collect and test the anterior nares specimen.

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

• For symptomatic individuals, the test is for serial testing at least twice over three days with at 

least 48 hours between tests.

• For asymptomatic individuals,the test is for serial testing at least three times over five days with 

at least 48 hours between tests.

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

authorized 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.

• 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.
1 96852 19500

8

The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic immunoassay device 

intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in 

anterior nasal swab specimens directly from individuals with or without symptoms or other 

epidemiological reasons to suspect COVID-19. 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.

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

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

• For in vitro diagnostic use. • For Emergency Use Authorization (EUA) only. • For ages 2 through 13, an adult must collect and test the anterior nares specimen. • This test does NOT determine if you had COVID-19 in the past or if you have immunity. • For symptomatic individuals, the test is for serial testing at least twice over three days with at least 48 hours between tests. • For asymptomatic individuals,the test is for serial testing at least three times over five days with at least 48 hours between tests. • In the USA, this product has not been FDA cleared or approved, but has been authorized 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.

• 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.