SARS-CoV-2 Test (Covid-19) Kit
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.).
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.
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.