COVID-19 PCR Test

• Patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing)
• Limited information is currently available to characterize the full spectrum of clinical illness associated with COVID-19.
• Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus.
• The median incubation period is approximately 5 days, but may range 2-14 days.
• Patients may be asymptomatic (without symptoms) for up to the full period of infection.

You should be tested if your healthcare provider believes you may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing), and/or because:

• You live in or have recently traveled to a place where transmission of COVID-19 is known to occur, and/or
• You have been in close contact with an individual suspected of or confirmed to have COVID-19.
• You or your healthcare provider believe there is another reason to investigate your COVID-19 infection status.

• If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. You should follow CDC guidance to reduce the potential transmission of disease.
• There is a smaller possibility that this test can give a positive result that is wrong (a false positive result) particularly when used in a population without many cases of COVID-19 infection. Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history and your symptoms.

• A negative test result means that the virus that causes COVID-19 was not found in your sample.
• However, it is possible for any test to give a negative result that is incorrect (false negative) in some people with COVID-19. You might test negative if the sample was collected early during your infection. You could also be exposed to COVID-19 after your sample was collected and then have become infected. In particular, people infected with COVID-19 but who have no symptoms may not shed enough virus to trigger a positive test.
• This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, 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. If you have no symptoms but have been tested because your doctor thought you may have been exposed to COVID-19, you should continue to monitor your health and let your healthcare provider know if you develop any symptoms of COVID-19. If you develop symptoms, you may need another test to determine if you have contracted the virus causing COVID-19.

If you develop symptoms or your symptoms get worse, you should seek medical care. If you have the following symptoms, you should seek immediate medical care at the closest emergency room:

• Trouble breathing
• Persistent pain or pressure in the chest
• New confusion
• Inability to wake up or stay awake
• Bluish lips or face

• Potential risks include:
  • Possible discomfort or other complications that can happen during sample collection.
  • Possible incorrect test result (see positive result and negative result FAQs above)

• 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 those you come in contact with.

COVID-19 spreads from person-to-person. When an infected person coughs, sneezes, or exhales air, droplets containing the virus go into the air and onto surfaces and objects around them. Other people are exposed to the virus by breathing in these droplets or by touching their eyes, nose, or mouth after touching infected surfaces.

There are limited treatments for COVID-19. Not all patients with COVID-19 will require medical attention, and most people recover within 2 weeks without any specific treatment. For severe cases, hospitalization may be required.

If you have any symptoms relating to COVID-19 and any of the following conditions or risk factors, which may put you at increased risk of severe illness from COVID-19, you should consult with your healthcare provider before using this test:

• Chronic kidney disease
• COPD (chronic obstructive pulmonary disease)
• Immunocompromised state (weakened immune system) from solid organ transplant or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines
• Obesity (body mass index [BMI] of 30 or higher)
• Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
• Sickle cell disease
• Type 2 diabetes mellitus
• Asthma (moderate-to-severe)
• Cerebrovascular disease (affects blood vessels and blood supply to the brain)
• Cystic fibrosis
• Hypertension or high blood pressure
• Neurologic conditions, such as dementia
• Liver disease
• Pregnancy
• Pulmonary fibrosis (having damaged or scarred lung tissues)
• Smoking
• Thalassemia (a type of blood disorder)
• Type 1 diabetes mellitus
• Children who are medically complex, who have neurologic, genetic, metabolic conditions, or who have congenital heart disease

COVID-19 is very contagious. The risk of getting COVID-19 depends on many factors, including where you live, recent travel history, and close contact with people who have symptoms. It is important to comply with any local travel restrictions and to protect yourself from exposure if you are in a city or area where the disease is spreading.

Vaccination for COVID-19 is highly recommended. Protect yourself by avoiding situations in which you may be exposed to the virus. Everyday actions can help protect you and prevent the spread of respiratory diseases such as COVID-19:

• Avoid close contact with people who are sick.
• Avoid touching your eyes, nose, and mouth.
• Stay home when you are sick.
• Cover your cough or sneeze with a tissue.
• Clean and disinfect frequently touched objects and surfaces.
• Wash your hands often with soap and water for at least 20 seconds.
• Use an alcohol-based hand sanitizer with at least 60% alcohol if soap and water aren’t available. Always wash hands with soap and water if hands are visibly dirty.

If you test positive for COVID-19 and have mild symptoms, the following steps can help prevent the disease from spreading to others:

Stay home

• Stay in a specific room and away from other people in your home
• Restrict any activities outside your home, except for getting medical care
• Avoid public areas, including work and school
• Avoid using public transportation, ride-sharing, or taxis

Cover your nose and mouth

• If you are sick, wear a facemask when you are around other people or pets
• Cover your mouth and nose with a tissue when you cough or sneeze, and throw away used tissues

Wash hands

• Wash your hands often with soap and water for at least 20 seconds
• Wash your hands especially after blowing your nose, coughing, sneezing, going to the bathroom, or before eating or preparing food
• If soap and water are not available, use an alcohol-based hand sanitizer that contains at least 60% alcohol
• Avoid touching your eyes, nose, mouth, and other people with unwashed hands

Do not share

• Do not share dishes, cups, eating utensils, towels, or bedding with other people or pets
• After using personal items, they should be washed thoroughly with soap and water

Clean and disinfect

• Clean high touch surfaces such as counters, tabletops, doorknobs, bathroom fixtures, toilets, phones, keyboards, tablets, and bedside tables
• Clean any surfaces that may come in contact with body fluids, blood, or stool
• Use a household cleaning spray or wipes
• Immediately remove and wash clothes or bedding that have body fluids, blood, or stool on them

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 Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics 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 of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

While we cannot evaluate all insurance coverage and your insurance carrier should be contacted for details, the test is reimbursable by most insurance plans, and this product is covered by participating HSA and FSA plans. An invoice is provided with every Amazon order and can also be downloaded through your Amazon order history. You will need to apply for reimbursement directly with your health insurance carrier and may need to provide the following information that can be found on both your invoice and test result:

• Patient information
• Ordering physician
• CPT code
• ICD-19
• HCPCS (if Medicare)
• Itemized cost of lab service
• Lab Tax ID#: 20-5016368
• NPI: 1780224659

Submit the itemized receipt through your healthcare insurance provider’s normal claims submission process. If you have questions about completing that process, we recommend reaching out to your insurance carrier directly. The American Medical Association established reimbursement at $100.