Q: What does this test measure?

The QuickVue At-Home OTC COVID-19 Test is a type of test called an antigen test. When you have COVID-19, SARS-CoV-2 (the virus that causes COVID-19) can be present in your nasal secretions. The QuickVue At-Home OTC COVID-19 Test can detect small parts of SARS-CoV-2 virus in your nasal secretions. These small parts of the SARS-CoV-2 virus are known as proteins or antigens.

Question 1

What is COVID-19?

Accepted Answer

Coronavirus disease (also called COVID-19) is an infection caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus), one of the most recently discovered types of coronaviruses. Those who have this disease may or may not experience COVID-19 symptoms, which range from mild to severe.

Question 2

What are symptoms of COVID-19?

Accepted Answer

People with COVID-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe illness. Some people do not show symptoms at all.

Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have COVID-19:

Cough
Shortness of breath or difficulty breathing
Fever
Chills
Muscle pain
Sore throat
New loss of taste or smell

This list is not all possible symptoms. Other less common symptoms have been reported, including gastrointestinal symptoms like nausea, vomiting, or diarrhea.

Question 3

Who is considered high risk for severe disease?

Accepted Answer

The following people are considered high risk for severe disease:

People aged 65 and older
People in nursing homes or long-term care facilities
People of all ages with underlying medical conditions, particularly if they are not well controlled:
- Cancer
- Chronic obstructive pulmonary disease
- Chronic kidney disease
- Immunosuppressed following solid organ transplant
- Obesity (BMI >30)
- Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
- Sickle cell disease
- Type II Diabetes
People may be at increased risk due to the following conditions:
- Asthma (moderate-severe)
- Cerebrovascular disease (affecting blood vessels to the brain)
- Cystic fibrosis
- High blood pressure
- Immunocompromised (weakened immune system) from blood or bone marrow transplants, immune deficiencies, HIV, use of corticosteroids, use of other immune weakening medications
- Neurologic conditions such as dementia
- Liver disease
- Pulmonary fibrosis
- Smoking
- Thalassemia
- Type I Diabetes

Question 4

What does this test measure?

Accepted Answer

The QuickVue At-Home OTC COVID-19 Test is testing for the presence or absence of nucleocapsid antigens from SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), which causes the disease Coronavirus Disease 2019 (COVID-19).

This is not an antibody test.

Question 5

Is this test FDA-approved or cleared?

Accepted Answer

No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Services’ (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

Question 6

What is the difference between a COVID-19 antigen, molecular, and antibody test?

Accepted Answer

There are different kinds of tests for diagnosing COVID-19. Molecular tests detect genetic material from the virus. The QuickVue At-Home OTC COVID-19 Test is a rapid antigen test that detects small parts or proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection. Antibody tests are not suitable to diagnose an active COVID-19 infection. You can find more information about COVID-19 testing from the FDA website.

Question 7

What does it mean if I have a positive test result?

Accepted Answer

A positive test result means it is very likely that you have COVID-19 if you have symptoms because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate at home as per CDC recommendations to stop spreading the virus to others.

If you have received a positive test result, especially if you are considered high risk (please see FAQ ‘Who is considered high risk for severe disease?'), you should take the following steps:

Consult a healthcare provider as soon as possible. Please tell them that you tested positive for COVID-19. Provide your healthcare provider with:

Your Test Result
The Fact Sheet for Healthcare Professionals

You should self-isolate at home as per CDC recommendations to stop spreading the virus to others.

Please consult the CDC recommendations regarding self-isolation
There is a chance that this test can give a positive result that is wrong (a false positive result), especially if you use the test when there are very few COVID-19 infections in your local community. Your healthcare provider will work with you to determine how best to care for you based on the test results along with your medical history, and your symptoms.

Question 8

What does it mean if I have a negative test result?

Accepted Answer

A negative test result indicates that you are unlikely to currently have COVID-19 disease. A negative test result means that proteins, which are small parts of the virus that causes COVID-19, were not found in your sample.

However, 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 your test result is negative, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, vaccine status, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.

The amount of antigen in a sample may decrease as the duration of illness increases. As days post-symptom onset increase, antigen test results may be more likely to be negative compared to a molecular SARS-CoV-2 test. You may also test negative at the very beginning of your infection before you develop symptoms.

If you are unwell, your symptoms are worsening, you develop new symptoms, or you are concerned, it is important that you see your healthcare provider, especially if you belong to a high-risk group (please see FAQ “Who is considered high risk for severe disease?”). Your healthcare provider will consider the test result with all other aspects of your medical history (such as symptoms, vaccine status, possible exposures, local community spread, and places you have recently visited) in deciding how to care for you. It is important that you work with a healthcare provider to help you understand the next steps you should take.

Question 9

Can I have a false positive test result?

Accepted Answer

There is a chance that this test can give a positive result that is incorrect (a false positive result).Anyone who receives a positive test result needs to consult a healthcare professional. If you have any doubt about your test result, please discuss it with a healthcare professional. This is especially important if you belong to a high-risk group (See FAQ “Who is considered high risk for severe disease?”) or develop emergency warning signs. The healthcare professional will work with you to determine how best to care for you based on your test result along with your medical history and symptoms.

If you do not have symptoms of COVID-19 and get a positive result, your test results should be confirmed with a molecular SARS-COV-2 test. Positive results from the QuickVue At-Home OTC COVID-19 Test are presumptive in asymptomatic patients, and have a higher risk of being false positives, particularly if you do not have a known SARS-CoV-2 exposure and/or live in an area known to have low numbers of SARS-CoV-2 infections.

For low-risk individuals, the CDC recommends that persons who receive a positive antigen test should isolate until they can be confirmed by a molecular test.

Question 10

Can the QuickVue At-Home OTC COVID-19 Test be used in children under age two?

Accepted Answer

No. The QuickVue At-Home OTC COVID-19 Test should not be used in children under the age of two. The test has not been validated for use in this age group and if you are concerned that your under two year-old child has COVID-19 you should see a healthcare provider for advice and further management.

Question 11

What is serial testing?

Accepted Answer

COVID-19 serial testing is when one person is tested for COVID-19 more than once at different points in time, such as every 24 to 72 hours. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. For individuals without symptoms of COVID-19, the BD Veritor™ At-Home COVID-19 Test test is intended to be used for serial testing, or used twice by the same individual over 2 or 3 days with at least 24 hours and no more than 48 hours between tests.

Question 12

What do I need to know about results from serial testing?

Accepted Answer

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 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 24-36 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.