What is COVID-19?


COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory illness, was first identified in Wuhan, China, and has now spread globally,
including the United States. There is limited information available to characterize the spectrum of clinical illness associated with COVID-19 but it likely spreads to others when a
person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). 

What are the symptoms of COVID-19?


Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, 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. Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days.

Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which may pose risks for public health. Please check the CDC webpage for the most up to date information.

What is the Laboratory Developed Test?


The Molecular LDT COVID-19 Authorized Test is designed, for use in a single laboratory, to detect the virus that causes COVID-19 in respiratory specimens, for example nasal or oral swabs.

Why was my sample tested?


You were 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.

Testing of the samples will help find out if you may have COVID-19.

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 below for more information).

Potential benefits include:

The results, along with other information, can help 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 others in your community.

What does it mean 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. There is a very small chance that this test can give a positive result that is wrong (a false positive result). 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. For COVID-19, a negative test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your recent illness.

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 this is the case, 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.

It is important that you work with your healthcare provider to help you understand the next steps you should take.

What do I need to know about COVID-19 testing?


Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section).

 

More Information


The Molecular LDT COVID-19 Authorized Test can be used to test respiratory specimens validated in the la CDC webpages:

General: https://www.cdc.gov/COVID19

Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html Information for Laboratories: https://www.cdc.gov/coronavirus/2019- nCoV/guidance-laboratories.html

Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019- nCoV/lab-biosafety-guidelines.html

Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control- recommendations.html

Specimen Collection: https://www.cdc.gov/coronavirus/2019- nCoV/guidelines-clinical-specimens.html

Infection Control: https://www.cdc.gov/coronavirus/2019- ncov/infection-control/index.html

FDA webpages:

General: www.fda.gov/novelcoronavirus

EUAs:(includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/emergency- situations-medical-devices/emergency-use-authorizations

Boratory that developed the test for COVID-19.