Biobank Graz

Common questions

How and where can I make my specimen available?

If you are a patient at University Hospital Graz and your specimen has been collected because of an illness, the doctor who is treating you will contact you. You will be asked if you would like to donate your tissue or fluid specimens to Biobank Graz for research purposes. The procedure will be explained once again in detail. You will receive an Informed Consent form that you can sign.

Can I also make my specimens available if I am not a patient of University Hospital Graz?

No. For reasons of specimen and data logistics and safety, Biobank Graz only includes specimens from patients of University Hospital Graz.

Why should I make my blood, tissue or any other body fluid available to Biobank Graz?

To better understand the causes of a disease and its progression, it is important to scientifically investigate tissue and blood specimens as well as other body fluids. The findings from these investigations are used to develop new procedures for diagnosis, prevention and treatment of disease that may be of benefit you one day. This is only possible if patients are prepared to make their specimens available.

What happens to my specimen?

Your specimen is archived in Biobank Graz for an unlimited period of time. Identified by a code, it is made available for research purposes in connection with the medical data that was collected. If a research project on your disease is conducted, the researcher can submit a request for your specimen to Biobank Graz.

As a donor, do I have the opportunity to influence the purpose for which the biological specimens are used?

No, the purpose cannot be influenced.

How long are my specimens stored?

Specimens are normally stored for an unlimited period of time until they have been used up as part of research projects or until the donor withdraws his/her written consent.

Will I be contacted in the event of new research findings that are personally significant for me?

Individual feedback on information and research findings obtained from your medical specimens is not foreseen.

Does the Informed Consent form apply to the current situation or is it permanent?

The informed consent applies both to the current situation and in case that blood is drawn in the future or tissue is removed during an operation. It also applies to specimens that have already been taken from you during necessary clinical procedures at University Hospital.

Are there any disadvantages to participating?

No. Your consent is completely voluntary and does not influence the diagnosis and treatment of your disease.

Do I need to return for another examination?

No. Your specimens are collected only as part of interventions necessary for your treatment and are not required (any longer) for your diagnosis and further treatment.

If I sign the Biobank Informed Consent form, will more tissue be removed during a biopsy?

No. During the planned procedure, no more tissue or other tissue is removed than what is required for diagnosis or therapy. The material that remains after the diagnosis has been made is not discarded but stored in Biobank Graz.

If I sign the Biobank Informed Consent form, will more blood be drawn?

Yes, but only if you are having a routine blood test may up to a maximum 20 ml additional blood (about 4 teaspoons) be drawn. Blood may not be drawn separately for the biobank alone.

Can I withdraw my informed consent?

Yes. You can withdraw your consent either in writing or orally without any reason at any time. If you wish, the specimens will be removed from Biobank Graz and destroyed.

Are there any disadvantages for me if I refuse or withdraw my informed consent?

No, none at all. All diagnostics and therapy are completely independent of your decision whether to make specimens available for Biobank Graz and thus for research.

How is the security of my personal data guaranteed?

Your specimens that are stored in Biobank Graz are identified by a code (pseudonymized). As a result of this code, even Biobank Graz staff do not have access to your personal data. Anyone who has access to these specimens and the pseudonymized data is obligated to maintain confidentiality. The Biobank Graz management is responsible for storage and if necessary destruction of specimens.

Does anyone external to Biobank Graz have access to my medical data as a result of my specimen donation?

No. Your specimens as well as the data concerning the course of your disease that are stored in the biobank are identified by a code (pseudonymized). This means that no outsider has access to your specimens and data. Only people directly involved who are also obligated to maintain confidentiality can access these pseudonymized specimens and data.

Do social insurance providers or employers have access to my data?

No. Neither social insurance providers nor employers have access to data regarding your specimens that are stored in Biobank Graz.

Will my specimens be sold and/or exploited for commercial purposes?

Biobank Graz is a non-profit, independent, publicly funded institution of the Medical University of Graz that exclusively serves to promote biomedical research. Biobank Graz does not pursue any commercial goals and does not seek profits. Biobank Graz specimens and data are NOT SOLD and are made available exclusively for research projects.

Do I need to pay anything to participate in research projects?

No. There is no cost to participate in this research project.

Are biological specimens collected from children as well?

No. Since children are subject to special protection, biological specimens and data from children are neither collected nor made available for research purposes.

Questions on convalescent COVID-19 cohorts

What does the Ab value indicate?

The SARS-CoV-2 Ab value indicates the presence of specific antibodies against the SARS-CoV-2 virus. It indirectly determines whether a person's immune system has come into contact with the virus and consequently formed antibodies. Depending on how well the immune system works, the human organism responds with a defensive reaction within a few hours to a few days after viruses enter it (= infection). This reaction involves the formation of specific antibodies against the virus (about 7 days after the symptoms start) as well as specific immune defense cells (T-cell response). Antibodies are usually formed against different elements of the virus particle (= antigens), which is also called "antibody repertoire." The main antigens of SARS-CoV-2 originate from the nucleocapside protein or spike protein of the virus. The SARS-CoV-2 antibody test primarily used in this study from the company Roche (Immunoassay Elecsys® Anti-SARS-CoV-2) detects the presence of antibodies to the spike (S) protein receptor-binding domain (RBD).

Information on this SARS-CoV-2 antibody test is available at: https://www.roche.de/diagnostik-produkte/produktkatalog/tests-parameter/elecsys-covid-19-solutions/

If Ab values are above a certain level, am I immune? Am I still protected if my Ab values are below 10?

It is currently not possible to declare with any certainty whether the presence or a certain amount of antibody (= titer) provides immunity and thus the person is protected against a new (re)infection with the SARS-CoV-2 virus. One of the goals of this study is to contribute to settling this question.

Immunobiological findings from other viral diseases verify that recovered, previously infected people normally have a much milder case of the disease when they are reinfected; however, exceptions to this rule are also known. One reason for this may be the different individual antibody repertoire that is built up during the initial infection. In the case of antibodies, it is not necessarily the amount (= antibody titer value) that is important but whether antibodies against the virus antigens are present, for example those that block or hinder the virus particles from entering into the cells of the organism. Thus, it may also be possible that a low titer of "blocking antibodies" provides better protection from reinfection than a high titer of "nonblocking antibodies."

May I continue to participate in the study if I am vaccinated?

Yes. During your next visit, please let us know if and when you were vaccinated and with which vaccine. This information is important for the study because it helps us to correctly interpret the development of the antibody titer.

When will findings from the study be available?

A first summary/publication of the study findings in a scientific journal is planned for the second quarter of 2021. The main goal of the study is to make a sound statement on the course of the titer of SARS-CoV-2 antibodies based on statistically reliable data. Data from the first four visits (up to 5 months after the initial infection) of the study participants will be summarized. The study findings will then be published in condensed form on the Biobank Graz website. If you provide us with your email adress, we would be happy to send you information electronically.

What is being investigated over the course of this study?

To combat a disease, suitable diagnostic tests and therapeutic measures/drugs must be developed. The basis for combating the COVID-19 disease caused by the SARS-CoV-2 virus is a sound characterization of its causes and disease progression. Our immune system is the main line of defense against a viral infection and source of sustainable immunity to a new infection. We have set up the “COVID-19-Genesenen-Studie” (COVID-19 convalescent study) to collect the best documented, high-quality blood specimens and data material (questionnaires) and make it available for COVID-19 research. Our study protocol as well as the accompanying ethics application have been examined and approved by the responsible ethics committee (EC number: 32-423 ex 19/20). At the start of the pandemic, it was important and urgent to clarify whether all people infected with SARS-CoV-2 form antibodies against the virus, how long specific antibodies can be detected in the blood and if they are able to protect against reinfection. Over the course of the study, new questions have arisen about disease progression, severity, less noticeable (long-term) symptoms or protective mechanisms (e.g., influence of blood group or antibodies in convalescent saliva). Researchers at our university use frozen serum from study participants as the control serum while testing new active ingredients that hinder virus particles from entering host cells. These active ingredients should have an effect similar to that of blocking antibodies from the serum of former COVID-19 patients.

We will also publish a short description of all conducted studies and study findings in condensed form on the Biobank Graz website immediately following their publication in scientific journals.

Will I be informed of the final results of the study?

It is not planned to provide study participants with systematic, individual feedback on the antibody test results. They can ask about results of an antibody test from their previous visit during their next visit. After an in-depth review by qualified experts, we will publish a summary of our study findings in scientific journals and then immediately in condensed form on the Biobank Graz website. Following international guidelines for good scientific practice, such publications handle data in anonymized form or exclusively as metadata.

Is it recommended that I get vaccinated if my Ab value is high?

As described above, the presence of SARS-CoV-2 specific antibodies alone in antibody test results does not permit serious, scientifically sound prediction of possible disease progression following virus reactivation or reinfection. The reason for this is that too little or no reliable study data is available. Symptoms and disease progression in the initial infection are not a reliable indicator of possible disease progression following reactivation/reinfection; however, it is assumed that following virus reactivation or reinfection with the same virus strain—especially within a period of time in which the immunological memory (antibodies and/or memory T-cells) is still active—a milder progression is to be expected. In general, the safety of SARS-CoV-2 vaccines (including Pfizer-BioNTech, AstraZeneca, Moderna) has been proven in clinical studies, which is why two of them have been approved by the European regulatory authority (as of January 2021). A vaccine causes (re)activation of a specific immune response to SARS-CoV-2 and is thus regarded as a sustainable, effective protection from infection.

Why do I have to indicate my blood group?

There are several publications by groups of researchers that indicate that blood group 0 may have a positive, protective effect since the relative frequency of people with blood group 0 is lower than would be expected from the general frequency of people with blood group 0 in the population. A connection between a specific blood group and the severity of COVID-19 infection is not yet known. Since we would also like to investigate/examine this relationship in our study, we require that you indicate your blood group accurately. This part of the study is led by researchers at the Department of Blood Group Serology and Transfusion Medicine.

Med Uni Graz study team

Representing the entire study team of the Medical University of Graz: Robert Krause (Department of Internal Medicine; study director) and Christian Gülly (Biobank at Med Uni Graz; coordination)

Cooperation partners/study team: Department of Internal Medicine; Clinical Institute of Medical and Chemical Laboratory Diagnostics; Department of Blood Group Serology and Transfusion Medicine; Diagnostic and Research Institute of Hygiene, Microbiology and Environmental Medicine; Institute of Medical Informatics, Statistics and Documentation; Biobank Graz.

Contact

Biobank Graz Office 
Neue Stiftingtalstraße 2 / Entrance B /Second floor, 8010 Graz
T: +43 316 385 72716