Frequently Asked Questions

• What is the Serimmune COVID-19 Study?

  The Serimmune COVID-19 Immunity study “Human antibody repertoire profiling for sero-surveillance of SARS-CoV-2 and other emerging pathogens” is intended to investigate personal immune response to infection by SARS-CoV-2 virus. Each individual makes their own unique set of antibodies to COVID-19, this study investigates how these differences may impact an individual’s experience with the disease.

  Serimmune has a proprietary technology for assessing immune response and the personal antibodies made by an individual. This technology, Serum Epitope Repertoire Analysis or SERA, allows us to measure the antibodies present in a specimen and map them back to specific locations, or epitopes, on the virus. We will use SERA to better understand your specific antibody response.

• What does it mean to be a “research participant” in the Study?

  This means that you agree to contribute your information to the Serimmune research study. As a participant, we will ask you to do a few things. We have summarized the most important ones below. If you have more questions, you can contact us at covid19study@serimmune.com.
  
  You will be asked to:

  1. Complete an informed consent document that will provide you details on the study and your participation in it. This is very important.
  2. Enroll through our website and complete a short health assessment.
  3. Provide a blood sample using a home collection kit for analysis.
  4. Provide additional samples from time to time or following infection with SARS-CoV-2.

• What am I consenting to by enrolling in the study?

  You are consenting to allow researchers to use your blood and associated health information to better understand the human antibody response to COVID-19 and other emerging novel and seasonal pathogens. We encourage participants to remain in the study for the full five-year period, however you may opt out at any time.

• Will my blood sample be used to diagnose SARS-CoV-2?

  The assay we will perform is not intended to be used as a clinical diagnostic test. If you have had exposure to the SARS-CoV-2 virus, the research assay is designed to characterize the antibody profiles that we see against the virus and track how they develop over time.

• What do I need to do to participate?

  1. Meet these eligibility requirements: 
     • You are over 18 years old and live in the United States. 
     • You are willing to provide blood samples using a home collection kit. 
     • You are willing to complete an online medical history questionnaire every time you provide a sample.
  2. Watch a video that explains the study.  
  3. Sign the Study Consent Form.  
  4. Register in the online study portal. 

• Do I need a diagnosis of COVID-19 to participate? What if I don’t have COVID-19?

  You do not need to have been diagnosed with COVID-19 to participate in the study. We will run your sample and provide you with the results. If you are exposed in the future, this will tell us about your specific immune response.

• What if I get COVID-19 during the study?

  If you are infected during the study, focus on getting well. Approximately two weeks after your symptoms started, we would appreciate a sample to test for your antibody response to this recent infection.
  If you would like to provide this additional sample, you may request a blood collection kit by emailing us at covid19study@serimmune.com

• What if I want to have the COVID-19 vaccine when it’s available?

  Our technology may be able to tell you about your specific immune response to the vaccine and how it differs from the immune response to the native virus.

• Who can I contact if I have more questions about the Serimmune COVID-19 Study?

  Email Serimmune at covid19study@serimmune.com for additional information.

• Why is this study helpful to Coronavirus research?

  We hope to better understand the antibodies that individuals make to SARS-CoV-2 and how this may be important for immunity, the duration of immunity, and for severity of symptoms.

• Will you share my data with third parties?

  Your personal identifying data will never be shared with third parties without your explicit consent; however, we may utilize your de-identified results in our research and technology development. A de-identified result is not tracible back to you personally. If you consent to participate in this study, we may only share your de-identified individual data and population level data with our research collaborators. Our collaborators are obligated to maintain strict levels of confidentiality for all data and will not have access to your personal identifiers.

• How do you protect the confidentiality of my data?

  All our data, when brought into our computing ecosystem, are disconnected from your contact and identifying information. Data are coded with a unique sample identifier (a sample ID) that does not contain any personal identifying information.

  Our research is performed in a secure computing environment with access restricted to research scientists and system administrators. Our computers and servers are procedurally, electronically and physically protected and monitored and are monitored for unauthorized activity.

• How will my sample be analyzed and stored?

  Your sample will be analyzed on Serimmune’s proprietary platform SERA or Serum Epitope Repertoire Analysis. Your sample may be stored frozen until the end of the study for re-analysis.

• I have had COVID-19. Is it safe for me to provide my sample to Serimmune?

  Absolutely. We are interested in the antibodies you may have made in response to infection.

• Will an Institutional Review Board (IRB) oversee the Serimmune COVID-19 study?

  Yes, this study is being conducted under oversight by WCG IRB study #1297772.