SARS-CoV-2 Test (Covid-19)

What is coronavirus (COVID-19)?

COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.).

What is the DxTerity SARS-CoV-2 (COVID-19) Test

The DxTerity SARS-CoV-2 RT-PCR CE Test is an end point reverse transcription polymerase chain reaction (RT-PCR) test followed by detection with capillary electrophoresis (CE) intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in saliva specimens collected from any individuals determined to be appropriate for COVID-19 testing by their healthcare provider (HCP), including from individuals without symptoms of COVID-19.

What are the symptoms of COVID-19?

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.
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Who should get tested?

You should be tested because 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 and your healthcare provider believe there is another reason to investigate your COVID-19 infection status.

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

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

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

A negative test result means that the virus that causes COVID-19 was 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. 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.

When should I seek medical care?

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

What are the known and potential risks and benefits of the test?

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.

DxTerity SARS-CoV-2 RT PCR CE Test

The DxTerity SARS-CoV-2 RT-PCR CE Test is an end point reverse transcription polymerase chain reaction (RT-PCR) test followed by detection with capillary electrophoresis from Saliva Samples. The SARS-CoV-2 primers are designed to detect RNA from SARS-CoV-2 genome from the nucleocapsid (N) gene, envelope (E) gene, and ORF1ab region and includes controls for RNase P.

Submission #: EUA202120
Granted by FDA: 8/28/2020
Device: DxTerity SARS-CoV-2 RT-PCR CE Test

Assay Performance: Symptomatic Patients (nasopharyngeal and swab samples vs. saliva)

Positive Agreement: 97.3% (36/37); 86.2-99.5%
Negative Agreement: 90.0% (36/40); 76.9.7-96.0%

Assay Performance: Asymptomatic Patients Combined (nasopharyngeal and swab samples vs. saliva) (1)

Positive Agreement: 84.6% (22/26);66.5-93.8%
Negative Agreement: 99.0% (513/518); 97.8-99.6%

1 There were four asymptomatic individuals which tested negative by the DxTerity SARS-CoV-2 RT-PCR test and positive by the NP swab with the Roche cobas SARS-CoV-2. The four samples had low viral loads at the limit of detection for the cobas SARS-CoV2 assay.

How does COVID-19 spread?

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.

How is COVID-19 treated?

There is currently no treatment 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. Treatment focuses on managing symptoms.

Who is at high risk of getting very sick?

If you have any symptoms concerning for 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

Am I at risk?

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.

How can I protect myself from getting COVID-19?

There are currently no vaccines for COVID-19. The best way to protect yourself is to avoid 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.

What can I do to prevent spreading COVID-19?

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

Is this test FDA-approved or cleared?

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).

What are the approved alternatives?

There are no approved available alternative tests. 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.

Is your COVID-19 test reimbursable through my insurance?

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.

This Test was developed and its performance characteristics determined by DxTerity Diagnostics Inc. DxTerity has established its accuracy and precision pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88). This Assay has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance and approval is not necessary. This laboratory is regulated under the Clinical Laboratory Improvements Amendments 1988 (CLIA-88) as qualified to perform high complexity clinical testing. This assay is used for clinical purposes and should be interpreted in reference to other laboratory and clinical findings.

Licensed, Certified & Accredited

Maintaining high standards is a core tenet of DxTerity’s commitment to quality. We maintain a Quality Management System that is ISO 13845 certified.
Our clinical diagnostic laboratory is College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified licensed.

SARS-CoV-2 Coronavirus Test