The Scanwell® App works with compatible iPhone, Google, and select Samsung smartphone models and operating systems. Check here for a complete list of compatible devices. Be advised: New devices are regularly added to the list.

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.

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.

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

The BD Veritor™ At-Home 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 BD Veritor™ At-Home 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.

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).

Most rapid antigen diagnostic tests, including those distributed by Everlywell, are designed to detect the nucleocapsid (N) protein from SARS-CoV-2. While it is more difficult to predict the impact of variants on the performance of rapid antigen tests, the FDA has not yet identified any rapid antigen tests that are known to be negatively impacted by the mutations in circulating variants. The BD Veritor™ At-Home COVID-19 Test is able to detect multiple variants, including Delta and Omicron*.

*Testing was performed on a representative sample for each variant

There are different kinds of tests for diagnosing COVID-19. Molecular tests detect genetic material from the virus. The BD Veritor™ At-Home COVID-19 Test is a rapid antigen COVID-19 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.

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 (saved within the Scanwell Health App)
• 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.

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 BD Veritor™ At-Home 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.

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.

The overall invalid result rate on 648 subjects that performed testing in a clinical study was 1.6% (10/638). An invalid result may occur for several reasons. There can be an issue with the quality control of the test or the sample is deemed inadequate. The invalid result rate from the clinical study demonstrates the frequency of quality control issues. You can also receive an invalid result if you do not scan your test stick within the defined time period after collection (5 minutes after the 15-minute incubation period). The Scanwell Health App will walk you through it, but it’s important to follow the in-app instructions to reduce the risk of an invalid result.

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 BD Veritor™ At-Home 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.

No. The BD Veritor™ At-Home 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 child under two years old has COVID-19, you should see a healthcare provider for advice and further management.

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.

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 BD Veritor™ 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 24-48 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 but experience COVID-19 like symptoms of fever, cough and/or shortness of breath, you should seek follow up care with your healthcare provider. It is important that you work with your healthcare provider to help you understand the next steps you should take.

Your test result is securely saved within the Scanwell Health App and you can share this record as proof of COVID-19 testing with your healthcare provider. Your name, date of birth, phone number, sex assigned at birth and address are pieces of information that you are required to provide because they are shared with the relevant health authorities to support monitoring of COVID-19 infection and test positivity rates across the country. Other personal information may be shared with the relevant health authorities; however, only if you choose to enter details in the optional information fields.

You can find more information about compatible devices here.

BD Veritor™ At-Home COVID-19 Test Fact Sheet for Individuals
BD Veritor™ At-Home COVID-19 Test Quick Start Guide