Quickvue at-home OTC Covid-19 Test User Instructions

RAPID RESULTS IN

MINS

QuickVue

At-Home

OTC COVID-19 Test

USER

INSTRUCTIONS

For Emergency Use Authorization (EUA) only.

In vitro

diagnostic use only.

Store at Room Temperature,

F to 86

F (15

C to 30

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.

Tubes

Tube Holder

Swabs

Watch or Timer

(not included)

Test Strips

ITEM

0569105 (05/17)

IVD

CONTENTS:

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

Remove the

SWAB

from

its wrapper, being

careful not to touch the

SWAB

head.

Gently insert the

SWAB

½ to ¾ 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.

Leave swab in

at least

1 minute!

Dispose of swab

in the trash.

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.

STEP 6:

Open the Test Strip

Open the

TEST

STRIP

pouch carefully at the slit

and hold the

TEST STRIP

indicated.

Tear here

LOT

IVD

CONTENTS:

One (1) Test Strip

Quidel Corporation

San Diego, CA USA

201621

2022

1465000 QV SARS

EXP

ITEM

0569105 (05/17)

Hold here

Do not touch here

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.

Leave strip

at least

10 minutes!

Arrows pointing down

STEP 8:

Remove Test Strip from the Tube

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.

Check for a Positive Result

Check for a Negative Result

Check for an Invalid Result

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.

Results shown at 2x.

Positive Result

POSITIVE

result must show

BOTH

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.

Positive COVID-19 Result

A positive test result means that proteins from the virus that causes COVID-19 were

found in your sample and it is very likely you have COVID-19 and it is important to be

under the care of your healthcare provider. It is also likely that you may be placed in

isolation to avoid spreading the virus to others. There is a very small chance that this

test can give you a positive test result that is wrong (false positive). If you test positive

with the QuickVue At-Home OTC COVID-19 Test you should self-isolate and seek

follow-up care with your healthcare provider as additional testing may be necessary.

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

based on your test result along with your medical history, and your symptoms.

Negative Result

STEP 11:

Check for a Negative COVID-19 Result

Place the

TEST STRIP

on the test strip outline below

and compare with test result examples shown.

Results shown at 2x.

NEGATIVE

result will show a

BLUE

line but

PINK

line.

Negative COVID-19 Result

A negative test result means that proteins from the virus that causes COVID-19 were not

found in your sample.

It is possible for this test to give a negative result that is incorrect (false negative) in some

people with COVID-19. This means that you could possibly still have COVID-19 even

though the test is negative. If you test negative and continue to experience COVID-19

like symptoms of fever, cough and/or shortness of breath you should seek follow up care

with your healthcare provider. Your healthcare provider will consider the test result

together with all other aspects of your medical history (such as symptoms, possible

exposures, and geographical location of places you have recently traveled) in deciding

how to care for you. For example, your healthcare provider may suggest you need

another test to determine if you have contracted the virus causing COVID-19.

It is important that you work with your healthcare provider to help you

understand the next steps you should take.

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.

Results shown at 2x.

Invalid Result

If there is

NO LINE

, or if there is

ONLY

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.

The QuickVue At-Home OTC COVID-19 Test is

for FDA Emergency Use Authorization (EUA) Only

For

In Vitro

Diagnostic (IVD) 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.

■

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 more information on EUAs go here:

https://www.fda.gov/emergency-preparednessand-response/

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.quickvueathome.com

Warnings, Precautions

and Safety Information

The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the

nucleocapsid protein antigen from SARS-CoV-2 from individuals within 6-days of symptom onset or

individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection when

tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

Read the written instructions fully before starting the test procedure

To ensure correct results, you must follow the instructions

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

Wear safety mask or other face covering when collecting swabs from children or others

Use of personal protection materials such as gloves are recommended

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

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 and the test should be repeated.

Do not use a test kit that is expired

Do not touch the swab head when handling the swab

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

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%

■

The solution in the tube contains hazardous ingredients (see table above). If the

solution contacts the skin or eye, flush with plenty of water. If irritation persists, seek

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

Intended Use

The QuickVue At-Home OTC COVID-19 Test is a lateral flow assay 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 with symptoms

of COVID-19 within the first six days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples

from individuals aged 2 years or older with symptoms of COVID-19 within the first six days of symptom onset. This test is also authorized for non-prescription home

use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals

aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 24

hours (and no more than 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. Antigen is generally detectable in anterior nasal 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 and 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.

Negative results should be treated as presumptive, 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 decisions. 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, and confirmed with a molecular assay, if necessary, for patient management. For serial

testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection,

such as in an individual with as a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection.

Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in

individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

Persons 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.

All results should be provided to a healthcare provider for public health reporting.

The QuickVue At-Home OTC COVID-19 Test is intended for non-prescription self-use and/or, as applicable for 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.

What do I need to know about

Results from Serial Testing?

If your first or second test is positive, then proteins from the virus that causes COVID-19

has been found in your sample and you likely have COVID-19.

If you test positive with the

QuickVue At-Home OTC COVID-19 Test, you should self-isolate and seek follow-up care with

your healthcare provider to determine the next steps you should take. You may need

additional testing, depending on your personal health history and other factors.

If your first test is negative, you should test again in 24-48 hours. If both your first and second tests

are negative, you may not have COVID-19, however, you should follow-up with your

healthcare

provider if you are at high risk for COVID-19 infection.

If you test negative and

continue to

experience COVID-19 like symptoms of fever, cough and/or shortness of breath you should

seek follow up care with your healthcare provider. For example, your healthcare provider may

suggest you need another test to determine if you have contracted the virus causing COVID-19.

It is important that you work with your healthcare provider to help you understand the next

steps you should take.

Frequently Asked Questions

Will this test hurt?

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

swab can feel slightly uncomfortable. If you feel pain, please stop the test

and seek advice from a healthcare provider.

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 Results section).

Potential benefits include:

■

The results, along with other information, can help 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.

What is Serial Testing?

COVID-19 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, especially when you

do not have any symptoms.

What is the difference between

an antigen and molecular test?

An antigen test, such as the QuickVue At-Home OTC COVID-19

Test, detects proteins from the virus. Molecular tests detect

genetic material from the virus. Antigen tests are very specific for

the virus, but not as sensitive as molecular tests. This means that a

positive result is highly accurate, but a negative result does not

rule out infection. If your test result is negative, you should

discuss with your healthcare provider on whether an additional

test is necessary and if you should continue isolating

at home.

There is a higher chance of false negative results with

antigen tests than with laboratory-based molecular tests.

This means that there is a higher chance this test will give

you a negative result when you have COVID-19.

How Accurate is this Test?

Based on the interim results of a clinical study where the

QuickVue At-Home OTC COVID-19 Test was compared to an

FDA

authorized molecular SARS-CoV-2 test, QuickVue

At-Home OTC COVID-19 Test correctly identified 83.5% of positive

specimens and 99.2% of negative specimens.

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

QuickVue

At-Home

OTC COVID-19 Test

RAPID RESULTS IN

MINS

A second test should be obtained with at least 24 hours

(and no more than 48 hours) between tests.

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).

Quidel Corporation

10165 McKellar Court, San Diego, CA 92121 USA

quidel.com

1479704EN00 (09/22)

USER

INSTRUCTIONS