SARS-CoV-2 Test (Covid-19)

What is coronavirus (COVID-19)?

Coronavirus disease (also called COVID-19) is a respiratory illness caused by a new type of virus. It was recently identified in Wuhan, China, and has spread globally. There have been an increasing number of cases reported in the United States, and it has become a global public health emergency.

What is the 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. The SARS-CoV-2 primers are designed to detect RNA from SARS-CoV-2 in saliva specimens from patients as recommended for testing by public health authority guidelines.

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 asymtomatic (without symptoms) for up to the full period of infection.
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Who should get tested?

You currently have symptoms of COVID-19
Live in or have recently traveled to an area with ongoing spread of COVID-19.
Have been in close contact with a person known to have COVID-19.
Think you may have been exposed to COVID-19

What will my test results tell me?

Your test results will confirm whether or not you are infected with COVID-19.
If your results are positive, it is important to limit your exposure to other people and continue to monitor your symptoms.
If your results are negative, you are not likely infected with COVID-19. However, it is important to note that the virus may not be detected by the test in early stages of infection when a person doesn't have any symptoms.
After receiving your results, you will have an opportunity to speak with a licensed physician, who can answer any questions you may have about your test results and help determine next steps in care.

Are there any risks involved in getting this test?

There is no risk involved in getting this test.
You will get a non-invasive, easy to use saliva collection device.
You will have the option to collect at a site or office or receive this test as a home kit.

How do I prepare for the test?

Abstain from eating food or drinking coffee 30 min prior to your saliva collection.
Detailed collection instructions will be provided to you at the lab or in your test kit.

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
Received by FDA: 7/15/2020 (Pending)
Device: DxTerity SARS-CoV-2 RT-PCR CE Test

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

Positive Agreement: 97.1% (34/35); 85.5-99.5%
Negative Agreement: 98.2% (550/560); 96.7-99.0%

Assay Performance: Asymptomatic Patients Combined (nasopharyngeal and swab samples vs. saliva) (1,2)

Positive Agreement: 93.3% (56/60); 84.1-97.4%
Negative Agreement: 98.2% (550/560); 96.7-99.0%

1 Of the 10 samples, which were negative by NP and positive by Saliva, 5 of these were from asymptomatic individuals.
2 The sole Negative discordant swab sample was Positive with cobas SARS-CoV-2 comparator assay, but Negative with the Hologic Panther Fusion® SARS-CoV-2 test and For the additional 3 samples which were negative by the DxTerity SARS-CoV-2 RT-PCR Test assay and positive by the NP swab with the cobas SARS-CoV-2 Ct values were on average >35.

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.

What are the symptoms of COVID-19?

Symptoms may appear 2 to 14 days after being exposed to the virus. The most common symptoms include:

Fever
New or worsening cough
Shortness of breath or difficulty breathing

Other less common symptoms may include:

Tiredness
Body or muscle aches
Nausea, vomiting, or diarrhea
Sore throat
Runny nose

Cases of COVID-19 range from mild to severe. Some people who are infected don’t have any symptoms and don’t feel sick. Most people have mild symptoms. More severe cases have been seen in older adults and those with weakened immune systems (including pregnant women) or underlying health issues (such as lung disease, diabetes, heart disease, kidney or liver disease, cancer, transplant, and AIDS).

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?

Most people have mild symptoms. More severe and fatal cases have been seen in older adults and those with weakened immune systems (including pregnant women) or underlying health issues (such as lung disease, diabetes, heart disease, kidney or liver disease, cancer, transplant, and AIDS).

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

When should I seek medical care?

If you think you have been exposed, it is important to closely monitor for symptoms. Seek medical attention immediately if you develop any symptoms, especially if you experience any of the following:

Fever > 101.5 ° F (taken with a thermometer)
Severe difficulty breathing
Coughing up blood
Chest pain
Swelling in the legs
Irregular heart rhythm
Yellowing of skin or whites of eyes
Dark-colored urine or urinating less often, or in smaller amounts than usual
Dark-colored urine
Persistent vomiting or diarrhea
Intense abdominal pain

Call ahead before visiting your healthcare provider. This will help the healthcare provider’s office keep other people from getting infected or exposed.

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