COVID-19 Spike Protein IgG Antibody Test

This TestFact is being provided to you because your sample was tested with the National Jewish Health COVID-19 Spike Protein IgG Antibody Semi-Quantitative Test. This TestFact contains information to help you understand the risks and benefits of using this test for SARS-CoV-2, the virus that causes COVID-19. After reading this TestFact, if you have any questions or would like to discuss the information provided, please speak with your healthcare provider.

Why was my sample tested?

You were tested because:

• Testing the sample can help determine if you may have IgG antibodies to COVID-19 as a result of vaccination with one of the spike protein-containing SARS-CoV-2 vaccines.
• Your healthcare provider thinks you may have been exposed to the virus that causes COVID-19 based on your current or past signs and symptoms (eg, fever, cough, shortness of breath).
• Live in or have recently travelled to a location where transmission of COVID-19 is known to occur.
• You have been in close contact with a person suspected or confirmed to have COVID-19.
• You have recovered from COVID-19.

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

Potential risks include:

• Possible discomfort, bruising, infection or other complications may occur during sample collection (serious complications are very rare).
• Possible incorrect test result (see below for more information).

Potential benefits include:

• The results and other information can help your healthcare provider make informed recommendations about your care.
• Test results can 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 (antibodies are detected), you may have been infected with the virus that causes COVID-19 at some time in the past or may have produced antibodies in response to vaccination with one of the current SARS. CoV-2 vaccines. There is still a chance that the antibodies indicate past infection due to other coronaviruses. These other coronaviruses cause the common cold. There is also a small chance that a positive result is incorrect (false positive).

The presence of IgG suggests that the infection or vaccination occurred weeks or months ago. It also suggests that you may no longer be infectious. IgG indicates that you may have some immunity to the virus, although you may not. How much it might protect you from getting sick with COVID-19 in the future is unknown.

Your healthcare provider will work with you to determine the best way to care for you based on the test results along with other factors in your medical history, including past symptoms, potential exposure to COVID-19, and the location of sites to which you have recently travelled.

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

A negative test result means that antibodies to the virus that causes COVID-19 or to the vaccine were not found in your sample. Some health conditions can make it difficult for your body to make antibodies against infection or vaccines. However, this test may give an incorrect negative result (false negative) in some people.

A negative result can occur if you are tested early in your illness or soon after vaccination and your body have not had time to produce antibodies. This means that you may still have COVID-19 even if you test negative or it is too soon after vaccination to detect antibodies. If this is the case, your healthcare provider will consider the test result along with all other aspects of your medical history (such as symptoms, possible exposures, and geographic location of places you have recently travelled) to Decide how to care for it.

Is this test approved or cleared by the FDA?

No. This test is not yet approved or approved by the US FDA. National Jewish Health researchers validated this test for use in antibody testing.

Where can I go for updates and more information?

The most up-to-date information on COVID-19 is available on the Centers for Disease Control and Prevention website. Also, contact your healthcare provider if you have any questions or concerns.

IF YOU ARE CURRENTLY SICK: You should not be tested for antibodies to COVID-19 at the National Jewish Health testing tent site because:

• The outdoor site is for testing only, not for treating sick people.
• It may not have started making antibodies yet.

Symptomatic individuals (regardless of physician referral) who need urgent medical evaluation or who are recovering from COVID-19 may also have this test done as part of their evaluation at COVID-19-related clinics. Call National Jewish Health for more information.

Sick people should seek medical attention by calling their doctor. They can also call National Jewish Health to determine if they need to be seen in a clinic or emergency department, or qualify to be tested for active COVID-19 (i.e., nasopharyngeal swab) at our outdoor testing site prior to going back home. People who are sick with COVID-19 or who may have COVID-19 should self-isolate from others until they recover, per CDC guidelines.