QUIDEL QuickVue At-Home COVID-19 Test Instructions
- June 6, 2024
- QUIDEL
Table of Contents
QuickVue At-Home
COVID-19 Test
USER
INSTRUCTIONS
For Emergency Use
Authorization (EUA) only.
In vitro diagnostic use only. Rx only.
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.
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.
B. 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
A. Immediately place the SWAB into the liquid inside the TUBE, and ensure it
is touching the bottom. Stir 3-4 times.
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 5
Remove Swab from the Tube
A. 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.
B. Dispose of swab in the trash.
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 it 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 is 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 it with the
test result examples shown.
A POSITIVE result must show BOTH a BLUE line and a PINK line near the BLUE line. Look closely! Even a very faint, pink Test Line and a blue Control Line is a POSITIVE result. The intensity of the lines may vary.
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 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.
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.
A NEGATIVE result will show a BLUE line but NO 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 to 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.
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 COVID-19 Test is also INVALID, call 833-QUICKVIEW
(833-784-2588) for assistance.
STEP 13
Dispose of 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.
Please notify your prescribing
Healthcare provider of the results of your QuickVue At-Home Covid-19 Test.
The QuickVue At-Home COVID-19 Test is for FDA Emergency Use Authorization
(EUA) Only
For Prescription Use Only. For In Vitro Diagnostic (IVD) Use.
- This product has not been FDA cleared or approved but has been authorized by FDA under a 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
- For prescription use only
- 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 a 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
(FI315)
Causes serious eye irritation (1-1319) May cause respiratory irritation
(H335)| 0.7%
Sodium Phosphate Dibasic Anhydrous/7558-79-4| Causes serious eye damage
(FI318)
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 (FI315)
Causes serious eye irritation (H319)| 0.03%
ProClin’9 300| 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 (1-1302)
Causes serious eye damage (FI318) 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
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.
You have the option to refuse this test. However, your doctor has prescribed this test because they believe it could help with your care.
What is the difference between an antigen and a molecular test?
An antigen test, such as the QuickVue At-Home 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 whether an additional test is
necessary and if you should continue isolating at home.
How Accurate is this Test?
Based on the interim results of a clinical study where the QuickVue At-Home
COVID-19 Test was compared to an FDA authorized molecular SARS-CoV-2 test, the
QuickVue At-Home COVID-19 Test correctly identified 84.8% of positive
specimens and 99.1% of negative specimens.
Intended Use
The QuickVue At-Home COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms. This test is also authorized for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms. The QuickVue At-Home COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2. Persons who test positive with the QuickVue At-Home COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary and for public health reporting. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in anterior nares specimens 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 definite cause of disease. Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out COVID-19 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 a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19. 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 prescribing 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 COVID-19 Test is intended for self-use and/or, as applicable for an adult lay user testing another person aged 8 years or older in a non- laboratory setting. The QuickVue At-Home COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Assistance
If the test does not perform as expected,
call 833-QUICKVIEW (833-784-2588).
Quidel Corporation
10165 McKellar Court, San Diego, CA 92121 USA
quidel.com
1479700 (03/21)
References
- HHS Accessibility & Section 508 | HHS.gov
- English | QuidelOrtho
- Coronavirus Disease 2019 (COVID-19) | CDC
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
- Homepage - QuickVue At-Home
- cdc.gov/csels/dls/sars-cov-2-livd-codes.html
- Contact Us | Poison Control
- Coronavirus (COVID-19) events as they happen