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COVID-19 Antigen Home Test

Package Insert

REF L031-118B5 REF L031-125M5 REF L031-125N5 REF L031-125P5 English 

A rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. 

For self-testing use. For use under an Emergency Use Authorization (EUA) only. 

Carefully read the instructions before performing the test. Failure to followthe instructions may result in inaccurate test results.

KIT CONTENTS 

Tube Holder

Extraction Disposable (only for 25 

Test Cassette Buffer Tube Nasal Swab test quantity) Package Insert 

PREPARATION SPECIMEN CO

TEST PROCEDURE

1. 2. 3. 4. 

Wash or sanitize your hands.Make sure they are dry before starting the test.

Check your kit contents and make sure you have everything. Check the expiration date printed on the cassette foil pouch. Do not use if the pouch isdamaged or open.

Open the pouch and lay the cassette on a clean, flat surface. Locate the Result 

Read the instructions. Window and Sample Well on the cassette. 

Result WindowSample Well

SELF COLLE

1. 2. 3. 4. 7. 8. 9. 10. 11. 

Punch through the perforatedcircle on the kit box to form a tubeholder. Place the tube in the tubeholder. For 25 test quantity kit boxthe tube holder is provided.

Gently insert the entire absorbent tip of the swab into 1 nostril

(1⁄2 to 3⁄4 of an inch). 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’shead while swabbing.Note: A false negative result may occur if the nasal swab specimen is not properly collected. 

Open the swab packaging at thestick end, not the swab tip. Donot touch the swab tip.

30 sec. 5x 

Immediately place the swab intothe tube and swirl for 30 seconds.Note: A false negative result may occur if the swab is not swirled at least 30 seconds. 

Rotate the swab 5 times whilesqueezing the tube. Note: A false negative result 

may occur if the swab is not 

rotated five times. 

Attach the dropper tip firmly onto 

the tube. Mix thoroughly by swirling or flicking the bottom of

the tube.

Gently squeeze the tub

solution into the Sampthe trash. Note: A false may occur if less thadded to the Sample 

Remove the swab while squeezing the tube. Dispose of the swab in the trash.

Remove the foil from the top of the extractionbuffer tube.

RESULT INTERPRETATION

Negative

An anterior naby an individuaged 2 to 13 y

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 at least 48 hours apart if you do not have symptoms on the first day of testing.A negative test result indicates that antigens from 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 healthcare provider. 

If the Control (C) line and th

Any faint visible red or pinbe read as positive. You do 

have a positive result at A positive test result meandetected in your sample aare contagious. Please coyour local health authorguidelines regarding self-ithis test can give a positive 

Positive 
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, ifthe 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 testsare 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 yoursample and you likely have COVID-19.

TEST INTERPRETATION

Repeat testing is needed to improve test accuracy. Please follo

w the table below when interpreting test 

results for COVID-19.

Status on first day of Testing 

First ResultDay 1

Second ResultDay 3

Third Result Day 5 Interpretation

With Symptoms

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

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

Without Negative Positive N/A Positive for COVID-19Symptoms 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.

FOR FDA EMERGENCY USE AUTHORIZATION (EUA) ONLY

 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 otherviruses 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 IVDs for detection and/or diagnosisof 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 more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-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: www.flowflexcovid.com

INTENDED USE

The Flowflex COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitativedetection of the nucleocapsid protein antigen from SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swabsamples 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-19within 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 COVID19, when tested at least three times over five days with at least 48 hours between tests.The Flowflex COVID-19 Antigen Home Test can be performed with or without the supervision of a telehealth proctor. The Flowflex COVID-19 Antigen 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 nasal (nares) samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and otherdiagnostic 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 Flowflex COVID-19 Antigen Home Test should self-isolate and seekfollow 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 beused as the sole basis for treatment or patient management decisions, including infection control measuressuch 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 healthcare provider. Individuals should provide all results obtained with this product to their healthcare provider for public healthreporting and to receive appropriate medical care. All healthcare providers will report all test results they

received from individuals who use the authorized product to relevant public health authorities in accordance

with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined bythe Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The Flowflex COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as applicable,for an adult lay user testing another aged 2 or older. The Flowflex COVID-19 Antigen Home 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.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the mainsource of infection; asymptomatic infected people can also be an infectious source. Based on the currentepidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main

manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and

diarrhea are found in a few cases. 

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION

 Read the Flowflex COVID-19 Antigen Home Test Package Insert carefully before performing a test.

Failure to follow directions may produce inaccurate test results. 

 Serial testing should be performed in individuals with negative results at least twice over thre

days (with 48 hours between tests) for symptomatic individuals and three times over five day

(with at least 48 hours between tests) for asymptomatic individuals. You may need to purchas

additional tests to perform this serial (repeat) testing.  If you have symptoms longer than 7 days you should consider testing at least three times over five day

with at least 48 hours between tests. 

 The Test is intended to aid in the diagnosis of active COVID-19. Please consult a healthcare profession

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. An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Childre

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 individua Leave the test cassette sealed in its pouch until just before use. Once opened, the test cassette shou

be used within 60 minutes. 

 Do not use the test after the expiration date shown on the test cassette pouch. For more information o

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

 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. Do not use with multiple specimens.  Make sure there is sufficient light when testing.  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 

the past six months. 

 False negative test results may occur if a specimen is incorrectly collected or handled.  Do not touch the swab tip when handling the swab.  Do not read test results before 15 minutes or after 30 minutes. Results read before 15 minutes or aft

30 minutes may lead to a false positive, false negative, or invalid result.  This test has not been validated for use with a video camera and faint bands may not be visible to telehealth proctor due to differences between cameras. 

 If applicable: Keep testing kit and kit components away from children and pets before and after us

Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. 

 The Reagent Solution contains a harmful chemical (see table below).

Hazardous Ingredients for the Reagent Solution

Chemical Name Harms (GHS) code for each ingredient Concentration

TX-100

H302 Acute oral toxicity H315 Skin irritation H318 Serious eye damageH400 Short-term (acute) aquatic hazardH410 Long-term (chronic) aquatic hazard

1%

Sodium Azide

H300 Acute oral toxicity H310 Acute dermal toxicity H373 Oral, Brain toxicityH400 Short-term (acute) aquatic hazardH410 Long-term (chronic) aquatic hazard

0.02%

 If the reagent solution contacts the skin, eyes, nose, or mouth, flush with large amounts of water. 

irritation persists, seek medical advice. https://www.poisonhelp.org or 1-800-222-1222

Serial Testing Information and Limitations

 If you have symptoms of COVID-19 that started within the last 7 days, you may need to test at lea

twice over three days with at least 48 hours between tests.  If you do not have symptoms of COVID-19, you may need to test at least three times over five days wi

at least 48 hours between tests.

 For serial testing, if your first test result is negative, you should test again in 48 hours if you hav

symptoms on the first day of testing, and test 2 more times at least 48 hours apart if you do not havsymptoms on the first day of testing. You may need to purchase additional tests to perform this seri

(repeat) testing.  There is a higher chance of false negative results with antigen tests than with laboratory-base

molecular tests due to the sensitivity of the test technology. This means that there is a higher chanc

this test will give a false negative result in an individual with COVID-19 as compared to a molecular tes

especially in samples with low viral load.  The performance of this test was established based on the evaluation of a limited number of clinic

specimens collected between March, 2021 and May, 2021. The clinical performance has not beeestablished for all circulating variants but is anticipated to be reflective of the prevalent variants circulation at the time and location of the clinical evaluation. Performance at the time of testing may vadepending on the variants circulating, including newly emerging strains of SARS-CoV-2 and theprevalence, which change over time.  All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assa

may be necessary. If you continue to have symptoms of COVID-19, and both your first and second tesare 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 sampand you likely have COVID-19.  This test is read visually and has not been validated for use by those with impaired vision or coloimpaired vision.

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

STORAGE AND STABILITY

 Store Flowflex COVID-19 Antigen Home Test between 2-30°C (36-86°F) until use. Ensure all kit components 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.

FREQUENTLY ASKED QUESTIONS 

Q: WHAT IS COVID-19?A: COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagiourespiratory illness. COVID-19 can present with mild to severe illness, although some people infected wi

COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medic

conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 includhospitalization and death. The SARS-CoV-2 virus can be spread to others even before a person showsigns or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms 

With Symptoms

Without Symptoms

With Symptoms

Without SymptomsWithout Symptoms




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eMed.com

Flowex® Test-to-Treat 

COVID-19 Rapid Antigen Test

EMCOV-001

COVID-19

RAPID 

ANTIGEN 

TEST

COVID-19

RAPID 

ANTIGEN 

TEST

Includes:

• 24/7 Telehealth Visit for COVID-19

• COVID-19 Rapid Antigen Test

© 2022 eMed® All rights reserved. 

The products of eMed are protected 

by patents.

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logo are trademarks of Google LLC.

App Store and the App Store 

logo are trademarks of Apple Inc.

Flowflex® is a trademark of ACON 

Laboratories, Inc

Flowex® Test-to-Treat 

COVID-19 Rapid Antigen Test

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ACON Laboratories, Inc.

San Diego, CA 92121, USA

Customer Support 1-800-838-9502

aconlabs.com

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.