QuickVue

At-Home

OTC COVID-19 Test

USER 

INSTRUCTIONS 

For Emergency Use Authorization (EUA) only. 

In vitro diagnostic use only. QUIDEt... Store at Room Temperature, 

■ FAST. EASY. READY WHEN YOU ARE. 

QuickVue 

At-Home 

OTC COVID-19 Test 

RAPID RESULTS IN ~  \SI

59°F to 86°F (15°C to 30°C) 
 

 

 

 

 

 

 

 

 

 

Using our mobile app (optional) 

For a stress-free testing experience download the QVueTM 

mobile app 

QVue helps you INTERPRET, SAVE, and SHARE your 

RESULTS. 

1. Visual step-by-step instructions to perform the test 

2. Guided test result interpretation steps 

3. Save, share, and send your result 

IMPORTANT: Timing is essential for accurate test results. 

Therefore, we suggest using EITHER the guided app 

experience OR these printed instructions to perform the 

entire test procedure. The QVue app has convenient 

built-in 

timers, but you cannot skip the countdown once 

initiated. 

(Requires iOS 13.0 or later, Android 9.0 or later) 
 

 

 

 

Wash Your hands 

Before you start testing, wash your 

hands or use hand sanitizer. 

Make sure your hands are dry 

before starting. 
 

 

 

 

 

 

 

 

STEP 1: 

Check Your Test Kit 

Locate the kit components: 

It is recommended gloves (not 

provided) also be used during 

testing. 

Check the expiration date printed on 

the test kit. Do not use the kit past 

its expiration date. 

For the most current expiration dates 

of this test, please refer to: 

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

 

 

 

STEP 2: 

Place Tube in the Tube Holder 

Remove cap from one TUBE and 

place it in the TUBE HOLDER. 

NOTE: Use of gloves 

is recommended. 
STEP 3: 

Swab theNostrils 

Remove the SWAB from 

its wrapper, being 

careful not to touch the 

SWAB head. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gently insert the SWAB 1⁄2 to 3⁄4 of an inch into the nostril, depending on 

the size of the person’s nose. Firmly rub the SWAB in a circular motion 

around the inside wall of EACH NOSTRIL at least 4 times. 

Be sure to rub BOTH nostrils with the SAME SWAB. 

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. 
STEP 4: 

Place Swab in the Tube 

Immediately place the 

SWAB into the liquid 

inside the TUBE, and 

ensure it is touching the 

bottom. Stir 3-4 times. 

Leave the swab in the 

solution for ONE MINUTE. 

NOTE: If the swab is in 

the solution for more 

than 10-minutes it 

should not be used. 

QuickVue 

At-Home 

OT C COVID-19 Test 

1 

Quic kVue At Horne u I c cov10 - ,s lc!Jt 
STEP 5: 

Remove Swab from the Tube 

After ONE MINUTE, 

remove the swab from the 

TUBE by rubbing the 

swab head against the 

inside wall of the tube to 

squeeze out as much 

liquid as possible. 

QuickVue 

At-Home 

OTC COVID-19 Test 

(;] Dispose of swab in 

the trash. 

QU DEL 
 

 

 

STEP 6: 

Open the Test Strip 

Open the TEST STRIP 

pouch carefully at the slit 

and hold the TEST STRIP as 

indicated. 
 

 

 

 

 

 

 

STEP 7: 

Place Test Strip in the Tube 

Place the TEST STRIP into the TUBE with the arrows 

pointing down. Leave the strip in the TUBE for a 

FULL TEN MINUTES – do not handle or remove. 
 

 

 

 

 

 

 

 

 

STEP 8: 

Remove Test Strip from the Tube 

At TEN MINUTES, remove the TEST STRIP from the TUBE 

and place on the test strip outline in Steps 10-12. Ensure the 

TEST STRIP is on a flat surface in good lighting. 

NOTE: The test is intended to be read at 10 minutes. 

If the test is read before this or is read more than 

5 minutes after the indicated read time, results 

may be inaccurate (false negative, false positive, 

or invalid) and the test should be repeated. 
 

 

 

 

 

STEP 9: 

Check Your Results 

There are three types of results possible. 

1. Check for a Positive Result 

2. Check for a Negative Result 

3. Check for an Invalid Result 
 

 

 

STEP 9: 

Check Your Results 

REPEAT TESTING is needed to improve accuracy. Please follow the table below when interpreting test results for COVID19. 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. 

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 

Negative Positive N/A Positive for COVID-19 

Symptoms Negative 

Negative 

Negative 

Negative 

Positive 

Negative 

Positive for COVID-19 

Negative for COVID-19 
 

 

 

 

 

 

 

 

 

STEP 10: 

Check for aPositive COVID-19 Result 

Place the TEST STRIP on the test strip outline below 

and compare it with the test result examples shown. 

Positive Result 

A POSITIVE result must show BOTH a BLUE 

line and a PINK line just below the BLUE line. 

Look closely! Even a very faint, pink Test Lineand 

a blue Control Line is a POSITIVE result. Pink 

shading or a line near the labels on the strip is not 

considered a positive result. 

You do not need to perform repeat 

testing if you have a positive result 

at any time. 
Positive COVID-19 Result 

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). 
STEP 11: 

Check for aNegative COVID-19 Result 

Place the TEST STRIP on the test strip outline below 

and compare with test result examples shown. 

A NEGATIVE result will show a BLUE line but NO 

PINK line. 

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. 

QuickVue 

At-Home 

OTC COVID-19 Test 

 Negative Result

OU DEL 
 

 

 

 

Negative COVID-19 Result 

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 healthcare provider. 
 

 

 

 

 

 

 

STEP 12: 

Check for an Invalid COVID-19 Result 

Place the TEST STRIP on the test strip outline below 

and compare with test result examples shown. 

Invalid Result 

If there is NO LINE, or if there is ONLY a PINK line, 

the test is INVALID and you should repeat the 

steps starting at the beginning using a new TUBE,  SWAB, and TEST STRIP.
 

 

 

 

 

 

Invalid COVID-19 Result 

If at 10 minutes, the blue Control Line does not appear, even if any shade of 

pink to-red Test Line appears, the 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 pre-filled tube and Test Strip. 

If the second QuickVue At-Home OTC COVID-19 Test is also INVALID, 

call 833-QUICKVUE (833-784-2588) for assistance. 
 

 

 

STEP 13: 

Dispose Used Test in the Trash 

All used test components should be 

disposed of in your household waste. 
 

 

 

Wash Your hands 

After completing all steps, wash hands 

or use hand sanitizer. 
 

 

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. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warnings, Precautions 

and Safety Information 

■ Read the written instructions fully before starting the test procedure. Failure to follow the instructions may result in 

inaccurate 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 14 years and older. Children aged 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. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warnings, Precautions 

and Safety Information 

■ Do not use kit past its expiration date. 

■ Do not touch the swab tip. 

■ Once opened, the test strip must be used within 60 minutes. 

■ Do not open the materials until ready for use. If the test strip is open for an hour or longer,invalid test results may 

occur. 

■ Improper swab collection may result in incorrectly negative (false negative) results 

■ Do not read test results before 10 minutes. Results read before 10 minutes or after 15 minutes may lead to false positive, 

false negative, or invalid results. 

■ Keep testing kit and kit components away from children and pets before and after use. 

■ Avoid contact with your skin, or eyes. Do not ingest any kit components. The reagent solution contains harmful 

chemicals (see Hazardous Ingredients for Liquid Reagent table below). 

■ If the solution contacts your skin or eyes, 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/emergencypreparednessand-response/mcm-legal-regulatory-and-policy-framework/emergencyuse-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.quickvueathome.com. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hazardous Ingredients for Liquid Reagent 

Chemical Name/CAS Harms (GHS Code) for each ingredient Concentration 

Sodium Phosphate Monobasic Monohydrate/10049-21-5 Causes skin irritation (H315) 

Causes serious eye irritation (H319) 

May cause respiratory irritation (H335) 

0.7% 

Sodium Phosphate Dibasic Anhydrous/7558-79-4 Causes serious eye damage (H318) 

Causes serious eye irritation (H319) 

0.7% 

C12-14-Alkyldimethyl-betaines/66455-29-6 Causes severe skin burns and eye damage (H314) 

Causes serious eye damage (H318) 

Causes skin irritation (H315) 

Causes serious eye irritation (H319) 

0.03% 

ProClin® 300 Harmful if swallowed (H302) 

Harmful if inhaled (H332) 

Causes severe skin burns and eye damage (H314) 

May cause an allergic skin reaction (H317) 

0.03% 

EDTA Tetrasodium Salt/64-02-8 Harmful if swallowed (H302) 

Causes serious eye damage (H318) 

Causes serious eye irritation (H319) 

Harmful if inhaled (H332) 

May cause respiratory irritation (H335) 

May cause damage to organs (H371), single exposure 

0.2% 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 January 2021 and March 2021. The clinical performance has not been 

established for all circulating variants but is anticipated to be reflective of the prevalent variants in 

circulation at the time and location of the clinical evaluation. Performance at the time of testing may 

vary depending on the variants circulating, including newly emerging strains of 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 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 colorimpaired vision. 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intended Use 

The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. 

This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior 

nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first six 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 othe r epidemiological reasons to suspect COVID-19, when 

tested at least three times over five days with at least 48 hours between tests. The QuickVue At-Home OTC COVID-19 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) swab specimens during the acute phase of 

infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine 

infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who 

test positive with the QuickVue At-Home OTC COVID-19 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. 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 QuickVue At-Home OTC COVID-19 Test is intended for non-prescription self-use and/or, as applicable an adult lay user testing another person aged 2 years or older in a nonlaboratory setting. The QuickVue At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDAcleared or approved. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Frequently Asked Questions 

What are the known and potential risks and 

benefits of this test? 

Potential risks include: 

■ Possible discomfort during sample collection. 

■ Possible incorrect test results (see Warnings and Results 

Interpretation sections for more information). 

Potential benefits include: 

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

healthcareprovider make informed recommendations 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-policyframework/emergency-use-authorization 

What is the difference 

between an antigen and a 

molecular test? 

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

that causes COVID-19. Molecular tests detect genetic 

material from the virus. Antigen tests, such as the 

QuickVue At-Home OTC COVID-19 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. 

How Accurate is this Test? 

Clinical studies have shown that antigen tests more accurately 

determine whether you are infected with the virus that 

causes COVID-19 when taken multiple times across several 

days. Repeat testing improves test accuracy. This serial 

testing approach is recommended to minimize the risk of 

incorrect results. For more information on the performance of 

the test and how the performance may apply to you, please 

refer to the performance data in the Healthcare Provider 

Instructions for Use (IFU), available at 

www.quickvueathome.com . 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Frequently Asked Questions 

What if I have a Positive Test Result? 

A positive result means that it is very likely you have 

COVID-19 because proteins from the virus that causes 

COVID-19 were found in your sample. You should selfisolate from others and contact a healthcare provider for 

medical advice about your positive result. 

What if I have a Negative Test Result? 

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 SARSCoV-2 infection; 

you may still be infected and you may still infect others. It 

is important that you work with your healthcare provider to 

help you understand the next steps you should take. 

What does an Invalid Test result mean? 

An invalid result means the test was not able to tell if you 

have COVID-19 or not. If the test is invalid, a new 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. 
Please notify your Healthcare provider of the 

results of your QuickVue At-Home OTC COVID-19 Test. 

ASSISTANCE 

If the test does not perform as expected, 

call 833-QUICKVUE (833-784-2588). 

Manufactured by: Quidel Corporation 

10165 McKellar Court, San Diego, CA 92121 USA 

quidel.com 1479705EN00 (01/23) 

QUIDEl:.. 

QuickVue· 

At-Home 

OTC COVID-19 Test 

USER 

INSTRUCTIONS 

RAPID RESULTS IN 
QuickVue 

At-Home 

OTC Covid-19 Test 

USER 

INSTRUCTIONS 

For Emergency Use 

Authorization (EUA) only. 

In vitro diagnostic use only. 

Take your test, lose the stress. TM Scan the QR code to download QVue, the optional mobile 

app that makes your testing experience easier than ever. 

(Requires iOS 13.0 or later, Android 9.0 or later) 

Wash Your Hands STEP 1

Before you start testing, Check Your Test Kit 

wash your hands or use 

hand sanitizer. Locate the kit components: 

Make sure your hands are 

dry before starting. 

It is recommended gloves (not provided) 

also be used during testing. 

Check expiration date printed on the test kit. 

Do not use the kit past its expiration date. 

For the most current expiration 

dates of this test, please refer to: 

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

Store at Room Temperature, 

59°F to 86°F (15°C to 30°C) 

STEP 2

Place Tube in the Tube Holder 

Remove cap from one 

TUBE and place it in the 

TUBE HOLDER. 

NOTE: Use of gloves 

is recommended. 

STEP 3 

Swab the Nostrils 

A Remove the SWAB 

from its wrapper, 

being careful not 

to touch the 

SWAB head. 

STEP 6

Open the Test Strip 

Open the TEST STRIP pouch 

carefully at the slit and hold 

the TEST STRIP as indicated. 

Tube Holder Tubes 

B Gently insert the SWAB 1⁄2 to 3⁄4 of an inch into the 

nostril, depending on the size of the person’s nose. 

Firmly rub the SWAB in a circular motion around the 

inside wall of EACH NOSTRIL at least 4 times. 

Be sure to rub BOTH nostrils with the SAME SWAB. 

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. 

STEP 7 

Place Test Strip 

in the Tube 

Place the TEST STRIP into the 

TUBE with the arrows pointing 

down. Leave the strip in the 

TUBE for a FULL TEN MINUTES

– do not handle 

or remove. 

STEP 8

Swabs Watch or Timer Test Strips 

(not included) 

STEP 4

Place Swab in the Tube 

A Immediately place 

the SWAB into the 

liquid inside the 

TUBE, and ensure it is 

touching the bottom. 

Stir 3-4 times. 

Remove Test Strip 

from the Tube 

At TEN MINUTES, remove the TEST 

STRIP from the TUBE. Next, place the 

TEST STRIP on the outline in Steps 

10-12. Ensure the TEST STRIP is on 

a flat surface in good lighting. 

NOTE: The test is intended to be read 

at 10 minutes. If the test is read before 

this or is read more than 5 minutes 

B Leave the swab in the 

solution for ONE MINUTE. 

NOTE: If the swab is in 

the solution for more 

than 10-minutes it 

should not be used. 

STEP 9 

Check Your Results 

STEP 5

Remove Swab from the Tube 

A After ONE MINUTE, B Dispose 

remove the swab from of swab in 

the TUBE by rubbing the trash. 

the swab head against 

the inside wall of the 

tube to squeeze out 

as much liquid as 

possible. 

There are three type of results possible. 

1. Check for a Positive Result 

2. Check for a Negative Result 

3. Check for an Invalid Result 

REPEAT TESTING is needed to improve 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. 

after the indicated read time, results

may be inaccurate (false negative, Status on First First Result Second Result Third Result Interpretation Day of Testing Day 1 Day 3 Day 5 false positive, or invalid) and the

Positive N/A N/A Positive for COVID-19 test should be repeated. With Negative Positive N/A Positive for COVID-19 Symptoms Negative Negative N/A Negative for COVID-19 

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

Without Negative Positive N/A Positive for COVID-19 

Symptoms Negative Negative Positive Positive for COVID-19 

Negative Negative Negative Negative for COVID-19 

STEP 10 

Check for a Positive COVID-19 Result 

Place the TEST STRIP on the test strip outline below and compare 

with test result examples shown. 

Positive Result 

A POSITIVE result must show 

Positive COVID-19 Result 

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). 

BOTH a BLUE line and a PINK 

line just below the BLUE line. 

Look closely! Even a very faint, 

pink Test Line and a blue Control 

Line is a POSITIVE result. Pink 

shading or a line near the labels 

on the strip is not considered a 

positive result. 

You do not need to perform 

repeat testing if you have a 

positive result at any time. 

Continued on other side 

TUBE HOLDER TUBE HOLDER TUBE HOLDER

TUBE HOLDER

TUBE HOLDER
For Emergency Use 

Authorization (EUA) only. 

In vitro diagnostic use only. 

USER 

INSTRUCTIONS 

Continued from other side 

Please notify your healthcare provider of the results of your QuickVue At-Home OTC COVID-19 Test. 

All used test components should be 

disposed of in your 

household waste. 

After completing all 

steps, wash hands or 

use hand sanitizer. 

Wash Your 

Hands 

STEP 13 

Dispose 

Used Test in 

the Trash 

Place the TEST STRIP on the test strip outline below and compare 

with test result examples shown. 

Negative COVID-19 Result 

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 healthcare provider. 

STEP 11 

Check for a Negative COVID-19 Result 

If there is NO LINE, or if there is 

ONLY a PINK line, the test is 

INVALID and you should repeat 

the steps starting at the 

beginning using a new TUBE, 

SWAB, and TEST STRIP. 

Place the TEST STRIP on the test strip outline below and compare 

with test result examples shown. 

STEP 12 

Check for an Invalid COVID-19 Result Invalid COVID-19 Result 

If at 10 minutes, the blue Control Line 

does not appear, even if any shade of 

pink to-red Test Line appears, the 

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 pre-filled 

tube and Test Strip. 

If the second QuickVue At-Home 

OTC COVID-19 Test is also INVALID, 

call 833-QUICKVUE (833-784-2588) 

for assistance. 

A NEGATIVE result will show a 

BLUE line but NO PINK line. 

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. 

Negative Result 

Invalid Result 

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. 

Warnings, Precautions and Safety Information 

 ̃ Read the written instructions fully before starting the test procedure. Failure to follow the instructions may result in inaccurate 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 14 years and older. Children aged 2 to 13 years 

should be tested by an adult. 

 ̃ Do not use on anyone under 2 years of age. 

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

 ̃ Do not use if any of the test kit contents or packaging is damaged. Test components are single-use. Do not re-use. 

 ̃ Do not use kit past its expiration date. 

 ̃ Do not touch the swab tip. 

 ̃ Once opened, the test strip must be used within 60 minutes. 

 ̃ Do not open the materials until ready for use. If the test strip is open for an hour or longer, invalid test results may occur. 

 ̃ Improper swab collection may result in incorrectly negative (false negative) results 

 ̃ Do not read test results before 10 minutes. Results read before 10 minutes or after 15 minutes may lead to false positive, 

false negative, or invalid results. 

 ̃ Keep testing kit and kit components away from children and pets before and after use 

 ̃ Avoid contact with your skin, or eyes. Do not ingest any kit components. The reagent solution contains harmful chemicals 

(see Hazardous Ingredients for Liquid Reagent table below). 

 ̃ If the solution contacts your skin or eyes, 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/emergencypreparedness-and-response/ 

mcm-legal-regulatory-and-policy-framework/emergencyuse-authorization 

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

 ̃ For detailed instructions, please visit www.quickvueathome.com. 

Hazardous Ingredients for Liquid Reagent 

Chemical Name/CAS Harms (GHS Code) for each ingredient Concentration 

Sodium Phosphate Monobasic Monohydrate/10049-21-5 Causes skin irritation (H315) 

Causes serious eye irritation (H319) 

May cause respiratory irritation (H335) 

0.7% 

Sodium Phosphate Dibasic Anhydrous/7558-79-4 Causes serious eye damage (H318) 

Causes serious eye irritation (H319) 

0.7% 

C12-14-Alkyldimethyl-betaines/66455-29-6 Causes severe skin burns and eye damage (H314) 

Causes serious eye damage (H318) 

Causes skin irritation (H315) 

Causes serious eye irritation (H319) 

0.03% 

ProClin® 300 Harmful if swallowed (H302) 

Harmful if inhaled (H332) 

Causes severe skin burns and eye damage (H314) 

May cause an allergic skin reaction (H317) 

0.03% 

EDTA Tetrasodium Salt/64-02-8 Harmful if swallowed (H302) 

Causes serious eye damage (H318) 

Causes serious eye irritation (H319) 

Harmful if inhaled (H332) 

May cause respiratory irritation (H335) 

May cause damage to organs (H371), single exposure 

0.2% 

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 January 

2021 and March 2021. The clinical performance has not been established for all circulating variants but is anticipated to be reflective 

of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary 

depending on the variants circulating, including newly emerging strains of 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 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. 

Intended Use 

The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid 

protein antigen from SARS-CoV-2. 

This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 

14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for 

individuals with symptoms of COVID-19 within the first six 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 QuickVue At-Home OTC COVID-19 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) 

swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with 

past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial 

infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive 

with the QuickVue At-Home OTC COVID-19 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 SARS-CoV-2 Tests provided by CDC. 

The QuickVue At-Home OTC COVID-19 Test is intended for non-prescription self-use and/or, as applicable an adult lay user testing 

another person aged 2 years or older in a non-laboratory setting. The QuickVue At-Home OTC COVID-19 Test is only for use under 

the Food and Drug Administration's Emergency Use Authorization. This product has not been FDA-cleared or approved. 

Frequently Asked Questions 

What are the known and potential risks and benefits of this test? 

Potential risks include: 

 ̃ Possible discomfort during sample collection. 

 ̃ Possible incorrect test results (see Warnings and Results Interpretation sections for more information). 

Potential benefits include: 

 ̃ The results, along with other information, can help you and your healthcare provider make informed 

recommendations about your care. 

 ̃ The results of this test may help limit the 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-and-response/ 

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

What is the difference between an antigen and a molecular test? 

There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests detect genetic material from the virus. 

Antigen tests, such as the QuickVue At-Home OTC COVID-19 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. 

How Accurate is this Test? 

Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 

when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to 

minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, 

please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at www.quickvueathome.com. 

What if I have a Positive Test Result? 

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. 

What if I have a Negative Test Result? 

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 SARSCoV-2 infection; you may still be infected and you may still infect 

others. It is important that you work with your healthcare provider to help you understand the next steps you should take. 

What does an Invalid Test result mean? 

An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new 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. 

Assistance 

If the test does not perform as expected, call 833-QUICKVUE (833-784-2588). 

Manufactured by: 

Quidel Corporation10165 McKellar Court, San Diego, CA 92121 USA, quidel.com 

1479705 (01/23) 
FAST. EASY. READY WHEN YOU ARE.

TESTS

2

1490703 (02/23) See Results Dip Swirl Swab

TESTS

2

TUBE HOLDER TUBE HOLDER

Includes two (2) tests with simple instructions

We created the QuickVue At-Home OTC COVID-19 Test so 

you can get fast, easy-to-understand results at home, 

without complicated procedures or extensive training. 

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Contains two (2) nasal swabs, two (2) test strips, two (2) pre-filled tubes, 

one (1) tube holder and one (1) user instructions.

Items necessary to use the test but not provided: Watch or Timer

Para instrucciones en Español, visite QuickVueAtHome.com.

For ages 2 and up. For ages 2 to 14, an adult must collect and test the anterior 

Keep testing kit and kit components out of the reach of nares specimen. 

children before and after use.

Determining a negative result requires multiple tests. You may need to 

purchase additional tests to perform serial (repeat) testing. Individuals 

with negative results who have symptoms of COVID-19, should test 

twice over three days with at least 48 hours between tests. Individuals 

with negative results who do not have symptoms of COVID-19, should 

test at least three times over five days with at least 48 hours between 

tests. 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 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 

 diagnostics for detection in vitro authorization of emergency use of 

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: 

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

Scan to download QVue,

TM the optional mobile app that

 makes your testing experience easier than ever.

(Requires iOS 13.0 or later, Android 9.0 or later)

For more information, call 833-QUICKVUE (833-784-2588) 

or visit us at QuickVueAtHome.com

Manufactured by Quidel Corporation,

trusted maker of medical diagnostic

tests for over 40 years.

10165 McKellar Court, San Diego, CA 92121 USA

quidel.com

For Emergency Use 

Authorization (EUA) only

Catalog Number 20402

Store between 59°–86°F (15°–30°C)

For in vitro diagnostic use
Swab Swirl Dip See Results

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We created the QuickVue At-Home OTC COVID-19 Test 

so you can get fast, easy-to-understand results at home, 

without complicated procedures or extensive training. 

Everything you need is in this package.

Contains two (2) nasal swabs, two (2) test strips, two (2) pre-filled tubes, 

one (1) tube holder and one (1) user instructions.

Items necessary to use the test but not provided: Watch or Timer

Para instrucciones en Español, visite QuickVueAtHome.com.

For ages 2 and up. For ages 2 to 14, an adult must collect and test the anterior 

nares specimen. Keep testing kit and kit components out of the reach of 

children before and after use.

1542600 (02/23)

2

TESTS

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mobile app that makes your testing 

experience easier than ever.

(Requires iOS 13.0 or later, Android 9.0 or later)

Determining a negative result requires multiple tests. You may need to 

purchase additional tests to perform serial (repeat) testing. Individuals 

with negative results who have symptoms of COVID-19, should test twice 

over three days with at least 48 hours between tests. Individuals with 

negative results who do not have symptoms of COVID-19, should test at 

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

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

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

For more information, call

833-QUICKVUE (833-784-2588) 

or visit us at QuickVueAtHome.com

Includes two (2) tests with simple instructions

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Contains ten (10) nasal swabs, ten (10) test strips, one (1) tube rack containing ten (10) pre-filled 

tubes and one (1) user instructions.

Items necessary to use the test but not provided: Watch or Timer

Para instrucciones en Español, visite QuickVueAtHome.com.

For ages 2 and up. For ages 2 to 14, an adult must collect and test the anterior nares specimen. 

Keep testing kit and kit components out of the reach of children before and after use.

Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial 

(repeat) testing. Individuals with negative results who have symptoms of COVID-19, should test twice over three days 

with at least 48 hours between tests. Individuals with negative results who do not have symptoms of COVID-19, 

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

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

We created the QuickVue At-Home OTC COVID-19 Test so you can get fast, 

easy-to-understand results at home, without complicated procedures or 

extensive training. Everything you need is in this package.

Swab Swirl Dip See Results

0) tests with simple instructions 1 Includes ten (

10

TESTS

Scan to download QVue,

TM the optional mobile app that

makes your testing experience easier than ever.

(Requires iOS 13.0 or later, Android 9.0 or later)

For Emergency Use

Authorization (EUA) only

Catalog Number 20427

Store between 59°–86°F (15°–30°C)

For in vitro diagnostic use

Scan to download QVue,

TM the optional mobile app that

 makes your testing experience easier than ever.

(Requires iOS 13.0 or later, Android 9.0 or later)

For more information, call 833-QUICKVUE (833-784-2588)

or visit us at QuickVueAtHome.com

Manufactured by Quidel Corporation,

trusted maker of medical diagnostic

tests for over 40 years.

10165 McKellar Court, San Diego, 

CA 92121 USA

quidel.com
FAST. EASY. READY WHEN YOU ARE.

Swab Swirl Dip See Results

25 E. RA OU Y HEN WY DAER Y. SAE ST. AF

TESTS

FAST. EASY. READY WHEN YOU ARE. 25

TESTS

Be prepared whenever testing is required

1486502 (02/23)

Includes twenty-five (25) tests with simple instructions

Scan to download QVue,

TM the optional mobile app that

makes your testing experience easier than ever.

(Requires iOS 13.0 or later, Android 9.0 or later)

We created the QuickVue At-Home OTC COVID-19 Test so you can get fast, 

easy-to-understand results at home, without complicated procedures or 

extensive training. Everything you need is in this package.

Swab Swirl Dip See Results

For Emergency Use

Authorization (EUA) only

Catalog Number 20398

Store between 59°–86°F (15°–30°C)

For in vitro diagnostic use Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial 

(repeat) testing. Individuals with negative results who have symptoms of COVID-19, should test twice over three days 

with at least 48 hours between tests. Individuals with negative results who do not have symptoms of COVID-19, 

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

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

Scan to download QVue,

TM the optional mobile app that

 makes your testing experience easier than ever.

(Requires iOS 13.0 or later, Android 9.0 or later)

For more information, call 833-QUICKVUE (833-784-2588)

or visit us at QuickVueAtHome.com

Manufactured by Quidel Corporation,

trusted maker of medical diagnostic

tests for over 40 years.

10165 McKellar Court, San Diego, 

CA 92121 USA

Contains twenty-five (25) nasal swabs, twenty-five (25) test strips, one (1) tube rack containing quidel.com

twenty-five (25) pre-filled tubes and one (1) user instructions. 

Items necessary to use the test but not provided: Watch or Timer

Para instrucciones en Español, visite QuickVueAtHome.com.

For ages 2 and up. For ages 2 to 14, an adult must collect and test the anterior nares specimen. 

Keep testing kit and kit components out of the reach of children before and after use.