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Texas CARES FAQ

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Question

Answer

Why should I participate?

There is currently little known about COVID-19 antibodies, including how long they last in the blood and/or what amount of protection they provide against future infection. Getting tested will help Texans understand how many people may have been infected and did not show symptoms, and how many Texans currently have COVID-19 antibodies (either from infection or vaccination) and how long they last. This will help inform decisions about vaccination schedules to help Texas fight COVID-19. The addition of the S-test will also allow you to evaluate your vaccine-induced immune response.

Who can participate?

Texans age 5-80. Anyone can participate, even if they have never been tested for COVID-19 or have tested positive or negative for COVID-19 in the past. We suggest waiting at least 14 days since a positive confirmed COVID-19 viral test before getting your antibody test. You can participate even if you have been vaccinated or plan to receive the vaccine soon. Antibody status of vaccinated individuals provides important information about vaccine-induced immunity. Fully vaccinated means having 2 doses of either Pfizer or Moderna vaccines, or 1 dose of Johnson & Johnson vaccine AND waiting 2 full weeks after the final dose from any vaccine.

Can I still participate in Texas CARES if I have gotten the vaccine or plan on getting the vaccine?

Yes! Our testing now detects both vaccine-induced antibodies as well as those developed after natural infection. Both vaccine-induced immunity and natural immunity are important to understanding where we stand in the progression to herd immunity. We encourage all participants to get the vaccine when it becomes available to you. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html

If I have gotten the vaccine, does a negative antibody result mean the vaccine didn’t work?

No. Immune response time varies. It typically takes up to 2 weeks after the second dose of the 2-dose mRNA vaccines available to achieve full immune response. Our program offers up to 3 tests over a 6-month period so you can know how your immune response changes over time. You will receive your next survey link 3 months after your test, which will generate your next order number.

Can I participate if I am already enrolled in another study?

You can still participate in the Texas CARES program if you are already enrolled in another study.

What is an antibody?

An antibody is a protein formed by your body in response to a specific foreign substance, such as a virus, that helps your body fight infection. Presence of an antibody in the blood can help identify a past infection. Antibodies are also produced in response to vaccination.

What is the difference between an antibody test and a viral test?

Antibody tests identify a past infection, while viral tests identify a current viral infection.

What is the difference between SARS-CoV-2 and COVID-19?

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a strain of coronavirus that emerged in 2019 that causes an acute respiratory disease named coronavirus disease 2019 (COVID-19). SARS-CoV-2 is the virus that causes COVID-19

What are the steps to enroll?

Complete the consent and survey at https://go.uth.edu/txcares.

Your lab order is automatically generated by our system and sent to a CPL lab unless you are a patient or employee at a participating clinic. You will receive a confirmation text upon completion of the survey that contains your order number.

                                                                                         

Do I need to pay for my COVID-19 antibody test at the CPL?

No, participation is free. Expenses are covered by Texas CARES

Do I need to schedule an appointment?

No, but we recommend checking the hours of operation for the CPL locations near you at https://www.cpllabs.com/locations/ before going to the lab. No appointment needed.

What do I need to bring to CPL?

Your picture ID and your confirmation text which contains your Requisition ID# 255799-XXXXXXXX

How will I get my results?

Your results (positive or negative for COVID-19 antibodies) will be texted to you 2-5 days after you get your blood drawn at CPL. You can access a full report on CPL’s portal after you receive the text message from Texas CARES. If your results are not loaded in the portal, please call the Sonic MyAccess customer service group at 512.339.1275

What does a negative antibody test result mean?

A negative antibody test means that you most likely have not been infected with the virus in the past. Antibodies may not be present among those tested early in the infection before antibodies develop. In some persons, antibody levels may become non-detectable after previously being present. If you currently have symptoms or have come into recent close contact with someone with COVID, please seek a virus test with your local public health department. Vaccine-induced immune response time varies. It typically takes up to 2 weeks after the second dose of the available 2-dose mRNA vaccines or one dose of the Johnson & Johnson vaccine to achieve full immune response. Our program offers up to 3 tests over a 6-month period so you can know how your immune response changes over time. You will receive your next survey link 3 months after your test, which will generate your next order number.

https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html

What does a positive antibody test result mean?

The presence of anti-SARS-CoV-2 antibodies indicates a previous infection and possibly at least some degree of  protection against future SARS-CoV-2 infection.  However, until the durability and duration of immunity are established, it cannot be assumed that individuals who test positive for SARS-CoV-2 antibodies, including total antibody, IgM, IgG, or IgA, are protected from future infection.

Asymptomatic persons who test positive by serologic testing without recent history of a COVID-19 confirmed or compatible illness have a low likelihood of active infection and should follow the CDC’s general recommendations to prevent infection with SARS-CoV-2. They should continue with normal activities, including work.

Persons who have had a COVID-19 compatible or confirmed illness should follow the CDC’s previous guidance regarding when to resume normal activities, including work, regardless of the presence of antibodies.

There should be no change in clinical practice or use of personal protective equipment (PPE) by health care workers and first responders who test positive for SARS-CoV-2 antibody.

https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html

What is the margin of error?

Roche Elecsys Anti-SARS-CoV-2 S (vaccine-induced & natural immunity)

Clinical specificity: 100%

Positive percentage agreement: at > or = 15 days post PCR confirmation: 96.6%

Negative Percent Agreement: 99.98%

https://diagnostics.roche.com/us/en/products/params/elecsys-anti-sars-cov-2-s.html

 

Roche Elecsys Anti-SARS-CoV-2 (natural-induced immunity)

Clinical specificity: 99.8%

Clinical sensitivity at > or = 14 days post PCR confirmation: 99.5%

Antibodies may not be present among those tested early in illness before antibodies develop or among those who never develop detectable antibodies following infection. We recommend waiting 14 days after a positive PCR COVID-19 test before getting tested for antibodies. https://diagnostics.roche.com/us/en/products/params/elecsys-anti-sars-cov-2.html

What COVID-19 antibody test is used?

 

Roche Elecsys Anti-SARS-CoV-2 S (semi-quantitative assay that detects antibodies from vaccination or past infection)

Roche Elecsys Anti-SARS-CoV-2 (qualitative assay that only detects antibodies from past infection)

More information about these tests:

https://go.uth.edu/testinfo

https://go.uth.edu/s-testinfo

Clinical overview of both tests

What does the COI number mean?

The cutoff index (COI) is the cutoff measurement used to identify antibody presence. Texas CARES uses a qualitative test that measures total antibody (IgM, IgG, IgA).

COI* < 1.0 = non-reactive

COI ≥ 1.0 = reactive

 

Information from Roche (the test manufacturer)

Interpretation of the results:

Results obtained with the Elecsys Anti?SARS?CoV?2 assay can be interpreted as follows:

The magnitude of the measured result above the cutoff is not indicative of the total amount of antibody present in the sample. The individual immune response following SARS?CoV?2 infection varies considerably and might give different results with assays from different manufacturers. Results of assays from different manufacturers should not be used interchangeably.

Will my results be shared with anyone?

Your personal results will not be shared with your employer, organization, or academic institution.

Why up to 3 tests?

Texas CARES is a longitudinal survey that aims to identify the specific protection from future COVID-19 infection provided by the anti-SARS-CoV antibodies as well as the duration of the presence of antibodies and a degree of protection. If you have antibodies present at T1, your T2 and T3 will identify how long those antibodies remain in your blood. The addition of the S-test will help us determine how long antibody response from vaccination lasts in our population.

How will I know when to get my second and third tests?

You will receive a text reminder with a personalized link to the T2 (3 months after your first test) and T3 surveys (3 months after your second test) that will generate your new order number to bring to CPL for your T2 and T3 draws. Please email us at texascares@uth.tmc.edu if you have not received your text message 3 months after your last antibody test.

Where can I go for updates and more information about COVID-19?

The most-up-to-date information is available on COVID-19 is available at the CDC general webpage: https://www.cdc.gov/COVID19.

 

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