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TRIAL OF NEW STRATEGIES FOR TRACKING CORONAVIRUS SARS-CoV-2

Information for adults

Dear Sir or Madam, dear interested participant,

We, the Heidelberg University Hospital, would like to invite you/your child to participate in our coronavirus research study. The study is funded by the German Federal Ministry of Education and Research, conducted by a team from Heidelberg University within the National Research Network of University Medicine on Covid-19 and supported by the local health authorities. This information sheet explains the purpose of this study, in which participants ages7 years and older, can participate.

The novel coronavirus SARS-CoV-2 has presented us with major challenges in recent months due to the pandemic. Currently, we are responding to rising case numbers by imposing coronavirus prevention measures (e.g. lockdown). The main reason is that people without symptoms can also pass on the virus and thus public health initiatives as implemented at the moment cannot respond in time. This would require a strategy that can also detect persons with asymptomatic infections at an early stage. We are testing a procedure that can solve this problem and ask you for your voluntary assistance.

To participate in the coronavirus research study, you/your child were randomly selected from addresses of your community and randomly assigned to one of the 4 strategies we want to test in the coronavirus research study. Because the study is of public interest, § 46 of the Federal Registration Act has allowed us to be provided with registration information from t a large number of people. The random selection was carried out by the Institute for Global Health at the University of Heidelberg in cooperation with the Leibniz Institute for Social Sciences in Mannheim (GESIS). The Ethics Commission of the University of Heidelberg has approved of this study. The requirements of data protection are guaranteed (for more on data protection, see reference here).

You or your child will be randomly assigned to one of the following testing strategies: (1) testing of the individual (2) testing of an entire household (3) immediate testing (4) or testing after a preceding inquiry of symptoms.

Usually only people who have Covid-19 symptoms, or who are at risk, are asked to go to their family doctor for a throat swab. A healthcare professional uses a cotton swab through the mouth or nose to the back of the throat and swabs material (secretions and cells). The sample is then tested in a medical laboratory for the presence of coronavirus. This laboratory technique is called “qPCR”.

We want to test randomly selected people from the general population, so that we can also detect persons infected with coronavirus without/with early symptoms. We will use two approaches:

  1. We want to use saliva instead of throat swabs. This has several advantages:
    a)A throat swab is quite unpleasant. Spitting into a small container is much easier and more pleasant.
    b) You can easily take a saliva sample yourself at home. Here and in a short video tutorial we explain what you need to do.
  2. We would like to use a different analysis method in the laboratory as well.
    Instead of the usual “qPCR” procedure, we use a newly developed alternative called “LAMP” which is technically much simpler. Both laboratory procedures are not perfect: If the coronavirus in the sample has not sufficiently multiplied, they may miss the infection.
    The LAMP procedure is currently still a research method, which has been greatly improved in recent months so that it is now as sensitive as the standard “qPCR” procedure. However, there has not yet been as much experience with the LAMP method. Therefore, a negative result of an RT-LAMP reaction is a little bit less reliable than a result obtained with the established qPCR method.
    However, we can identify infectious persons very well with the LAMP test and in some cases, we can detect the virus up to 1 or 2 weeks after Covid-19 symptoms have worn off. We can also detect the virus 1 or 2 days before symptoms develop: With the same laboratory capacity and the same number of laboratory technicians, we are able to test many more people than would be possible with the qPCR test.

A good overview in English of the current status of qPCR and alternative testing methods can be found in our link list.

  1. First of all, you should read this information brochure carefully and consider whether you agree with everything and whether you would like to participate in the coronavirus research study. If so, please fill out the enclosed consent form. Please include your telephone number or e-mail address so that the public health department can contact you in case of a positive test and discuss further measures with you.
  2. Keep the access code in the top right-hand corner of the letter, you will need it for the result inquiry in the internet or on the telephone.
  3. Find instructions on how to collect a saliva sample here or in a short video
  4. Prepare the enclosed materials for collection of the saliva specimen and then collect the saliva sample as shown in the brochure or video.
    IMPORTANT: If possible, collect the saliva sample before breakfast and before brushing your teeth. This will allow for greater accuracy.
  5. Finally, send us the tube together with the declaration of consent and the questionnaire, if you received one, by mail free of charge. The return shipment may only be made with the enclosed envelope suitable for sending the sample.

    IMPORTANT: Please take your sample during the week (Monday through Friday) and send it off via mail on the same day, if possible.

    Participating in the Corona research study should take you around 10 to 20 minutes.

If we can detect the coronavirus in your/your child’s sample with our test (positive result), you will receive a preliminary result and we will check the result again with the established qPCR method (confirmatory test). You do not need to take a throat swab for this, we will also perform this analysis with the saliva sample you already have submitted. If the qPCR test is also positive, we will inform the public health department about the test result. This is necessary because COVID-19 is a notifiable disease. The Health Department will then contact you and inform you about the confirmed positive test result and about further measures. Typically, the Health Department will ask you to go into quarantine and work with you to identify the people you may have been in contact with.

You can also retrieve the result yourself here or you can call the study information desk (Tel. 06221 522-2399, Monday to Friday 7-11 am and 2-6 pm ) ask. Even if it should be negative (no virus detected), it is still not a complete all-clear. There is no test that is 100 per cent accurate. The test method used here is a research method, the accuracy of which has not yet been finally clarified. However, initial investigations indicate that the accuracy is in the range of the established qPCR method.

But even if you were not infected at the moment of the saliva sample, that does not mean that you may not have become infected a short time later. Or you had been infected shortly before, but the virus had not yet reproduced enough to be detectable. The test only provides information about the current situation at the time the sample was taken. Therefore, this test in no way releases the public from the hygiene and protective measures specified and we ask you to continue to carefully observe them.

Everyone who participates in the study supports the aim of managing the pandemic situation in Germany for the long term and may help to avoid further large-scale restrictions in public life.

If you are actually infected with the coronavirus, there is a good chance that the test will detect this. If you know that you are infected, you can quarantine yourself at home and protect your family, friends and colleagues from infection. You may also know a little earlier than usual if the disease is more severe. However, please note that even a negative test result does not mean that you can take distance and hygiene measures less seriously: You can still get infected at any time.

Submitting a saliva sample does not pose any risk to you. The vial is filled with sterile salty water, so its contents are harmless. All materials supplied are food safe and can be stored without any special requirements. Some people may find it uncomfortable to give the saliva sample for this study. There is a small risk of short-term discomfort. In rare cases, the participants report slight nausea shortly after gargling or a briefly blocked nose after clearing their throat.

The study is conducted by a team from the University of Heidelberg within the National Research Network of University Medicine on COVID-19. We are also supported by the local health authorities. The study is funded by the Federal Ministry of Education and Research and thus by all of you, the tax-paying citizens - thank you very much.

Everyone who is sent a test tube is invited to take part in the study. A prerequisite for participation is your declaration that you feel sufficiently informed by the explanations given here and that you agree to the procedure described.

We, the Heidelberg University team, have asked all communities in the Rhine-Neckar region for addresses for the study via the public health department. Your address was selected randomly. We use the address data only to contact you and to assign the saliva samples to the persons; your data will not be passed on. The saliva samples are processed only using the codes (this is called pseudonymization) attached to the test tubes. The positive results are also transmitted in a pseudonymized manner to the public health department. There, a single authorized data officer has the option to trace back the coes to the actual names, telephone numbers, and email addresses.

The transmission of positive cases is necessary because COVID-19 is a notifiable disease. The scientific analyses carried out at the university occur only using the pseudonymized codes.

Dr. Simon Anders, Center for Molecular Biology at the University of Heidelberg (ZMBH),
Im Neuenheimer Feld 324, 69120 Heidelberg

The collection, storage and processing of your data is carried out according to the data protection regulations of the “Art 6. §1” of the German data protection law (DSGVO) and the data protection standards of the European Union. Your contact data will only be used to contact you for study recruitment purposes. Once we have received the saliva samples and the test results are available, a very small number of participants will be contacted again and asked about their experiences. Afterwards, your data will be pseudonymized, i.e. all names, address data, and (if available) telephone numbers and e-mail addresses will be removed from your data set. Only the public health department can access this data in case of a positive test result, to contact you. All scientific analyses are carried out using the pseudonymized data. A human genetic analysis will not be performed. We only use the coronavirus gene snippets in your saliva sample.

If you do not want to take part in this study, your contact details (name, address and, if applicable, telephone number and email address) will be deleted from our directory at the end of the study. No medical findings will be collected during the study. The address data is stored in a database that is only accessible to the authorized data officers at the university and the local health authorities. In addition, information on the place, date and time of issue of the test tube is collected, which is linked to the code issued on the test tube. To report to the health department in the event of a positive test result, we will also ask for your telephone number and / or email address. The study management will take all reasonable steps to ensure the protection of your data in accordance with the data protection standards of the European Union. The data is encrypted and secured against unauthorized access. The names, address data, telephone numbers and e-mail addresses collected during the study will be destroyed after completion of the study.

All research data, including laboratory data, may also be used in future studies on coronaviruses / other respiratory viruses and/or published in scientific journals. The biomaterials of positive samples will be stored pseudonymized for the further development of testing diagnostics. The human genome is not sequenced. This data will not contain any information that identifies you as a participant in this study. The data is protected against unauthorized access. You can refuse the use of your data for future research purposes in connection with coronaviruses/other respiratory viruses in the consent form.

You have the right to request information from the person responsible (see below) about the storage of your personal data. You can also demand the correction of inaccurate data and the deletion of data or restriction of its processing.

The person responsible for the study-related collection of personal data is:

Dr. Simon Anders, Center for Molecular Biology at the University of Heidelberg (ZMBH),
Im Neuenheimer Feld 324, 69120 Heidelberg

If you have any questions regarding data processing and compliance with data protection requirements, you can contact the following data protection officer at the institution:

Heidelberg University Hospital, data protection officer Im Neuenheimer Feld 672, 69120 Heidelberg

Tel: 06221 56 70 36
Tel: 06221 56 70 36
E-Mail: datenschutz@med.uni-heidelberg.de

In case of illegal data processing you have the right to complain to the following supervisory authority:

The State Commissioner for Data Protection and Freedom of Information Baden- Württemberg

Postfach 10 29 32, 70025 Stuttgart

Tel: 0711 61 55 41 – 0,
Fax: 0711 61 55 41 – 15,
E-Mail: poststelle@lfdi.bwl.de

Internet: www.baden-wuerttemberg.datenschutz.de

Participation is voluntary and free. Unfortunately, it is not possible to pay any compensation for expenses which may have occurred. If you would like to participate in the study, we ask you to sign the consent form. You can revoke this consent at any time in writing or verbally without explanation and without incurring any disadvantages. If you do so, your personal data will be deleted, so that the result of your sample can no longer be attributed to you. If you withdraw from the study, materials already obtained can be destroyed upon request. However, if your sample has already been analyzed the test should prove positive, we will still transmit the code of the sample to the public health department, as we are obliged to report. If you do not wish to participate, simply do not fill out the form and throw the test tube away.

For further information as well as for information about general results and the outcome of the study please contact the head of the study, Dr. Andreas Deckert (contact via phone 06221 522 – 2399 or E-Mail: info@virus-finder.de)

In addition you can find information about the study on the study website and from the study’s telephone hotline..

Study website: www.virus-finder.de
Information via phone: 06221 522 – 2399

Monday through Friday from 7-11 am and 2-6 pm
The hotline will be in operation from 18.11.2020 until 23.12.2020.

We would greatly appreciate your participation in this scientific study!

Information for minors

This text explains the aims of this study on the Corona virus. Participants between 12 and 17 years of age should read this information and ask adults if they have further questions. The participants have to give their consent and confirm that they asked adults if they did not understand some aspect of the study.

Dear participant or interested person,

We, the Heidelberg University Hospital, would like to invite you/your child to participate in our coronavirus research study.

The novel coronavirus SARS-CoV-2 has presented us with major challenges in recent months due to the pandemic. Currently, we are responding to rising case numbers by imposing coronavirus prevention measures (e.g. lockdown). The main reason is that people without symptoms can also pass on the virus and thus public health initiatives as implemented at the moment cannot respond in time. This would require a strategy that can also detect persons with asymptomatic infections at an early stage. We are testing a procedure that can solve this problem and ask you for your voluntary assistance.

To participate in the coronavirus research study, you were randomly selected from addresses of your community and randomly assigned to one of the 4 strategies we want to test in the coronavirus research study. Because the study is of public interest, § 46 of the Federal Registration Act has allowed us to be provided with registration information from t a large number of people. The random selection was carried out by the Institute for Global Health at the University of Heidelberg in cooperation with the Leibniz Institute for Social Sciences in Mannheim (GESIS). The Ethics Commission of the University of Heidelberg has approved of this study. The requirements of data protection are guaranteed (for more on data protection, see reference here).

You or your child will be randomly assigned to one of the following testing strategies: (1) testing of the individual (2) testing of an entire household (3) immediate testing (4) or testing after a preceding inquiry of symptoms.

Usually only people who have Covid-19 symptoms, or who are at risk, are asked to go to their family doctor for a throat swab. A healthcare professional uses a cotton swab through the mouth or nose to the back of the throat and swabs material (secretions and cells). The sample is then tested in a medical laboratory for the presence of coronavirus. This laboratory technique is called “qPCR”.

We want to test randomly selected people from the general population, so that we can also detect persons infected with coronavirus without/with early symptoms. We will use two approaches:

  1. We want to use saliva instead of throat swabs. This has several advantages:
    a) A throat swab is quite unpleasant. Spitting into a small container is much easier.
    b) You can easily take a saliva sample yourself at home. In the brochure and in a short video we will explain to you what you need to do.
  2. You can easily take a saliva sample yourself at home. In the brochure and in a short video we will explain to you what you need to do. We also want to use a different laboratory method. Instead of the usual “qPCR” procedure, we use a newly developed alternative called “LAMP” which is technically much simpler. Neither of the methods is perfect and if a sample contains only a few viruses the infection may or may not be detected.

    The LAMP procedure is currently still a research method, which has been greatly improved in recent months so that it is now as sensitive as the standard “qPCR” procedure. However, there has not yet been as much experience with the LAMP method. Therefore, a negative result of an RT-LAMP reaction is a little bit less reliable than a result obtained with the established qPCR method. However, we can identify infectious persons very well with the LAMP test and in some cases, we can detect the virus up to 1 or 2 weeks after Covid-19 symptoms have worn off. We can also detect the virus 1 or 2 days before symptoms develop: With the same laboratory capacity and the same number of laboratory technicians, we are able to test many more people than would be possible with the qPCR test.

    A good overview with resources about qPCR and alternative testing methods can be found on our link list: www.virus-finder.de/links

  1. First of all, you should read this information leaflet carefully and consider whether you agree with everything and whether you want to take part in the corona research study. Then please fill out the attached declaration of consent, sign it and have it signed by your parents or guardians. Please include your telephone number or email address so that the health department can contact you in the event of a positive test and discuss further measures with you.
  2. Keep the access code which is at the top right of the cover letter, you will need it to get your test results over the Internet or on the phone!
  3. You can find a tutorial for taking a salive sample here or in a short video hier.
  4. Prepare the enclosed materials for submitting the saliva sample and then submit the saliva sample as shown in the instructions or the video.

    IMPORTANT! If possible, take the saliva sample before breakfast and before brushing your teeth. This makes the test more accurate.

  5. Finally, send us the tube together with the declaration of consent (if you have also received a questionnaire and filled it out, this too, if possible) by post free of charge. The return may only be made with the enclosed return envelope suitable for sending samples. You can find instructions on our website ( www.virus-finder.de ) and in the cover letter.

    IMPORTANT! Please take the sample on weekdays (Monday to Friday) and, if possible, put the return envelope with the sample material via mail on the same day.

    The whole procedure should take you around 10 to 20 minutes.

If we can detect the virus in your sample with our test (positive result), you will receive a preliminary result and we will check the result again using the established qPCR method. You do not need to give a throat swab, we will also carry out this analysis with the saliva sample we already got from you. If the qPCR test is also positive, we will inform the health department about the test result. The submission of positive cases is required because Covid-19 is a notifiable disease. The health department will then contact you and inform you about the confirmed positive test result and talk to you about further measures. Typically, the health department will ask you to go to quarantine at home and work with you to find out if you may have infected anybody.

You can get your result here or you can call the study’s telephone hotline service (telephone number 06221 522-2399 from Monday to Friday 7am-11am and 2pm-6pm between 18/11/2020 until 23/12/2020). Even if it should be negative (no coronavirus detected), this does not necessarily mean that no virus is present as there is no test with one hundred percent accuracy. The test method used here is a research method whose accuracy has not yet been conclusively clarified. However, initial investigations indicate that the accuracy is in the range of that of the established qPCR method. However, even if you were not infected at the moment of taking the saliva sample, this does not mean that you have been or will be infected later. Or you may have been infected shortly before testing, and the virus had not yet multiplied sufficiently to be detectable. The test only gives information about the current situation at the time of sampling. Consequently, the test does not change anything about the recommended or mandatory hygiene measures that have been put in place to protect against an infection. Please keep following these measures independent of the result.

Everyone who participates in the study supports the aim of managing the pandemic situation in Germany for the long term and may help to avoid further large-scale restrictions in public life.

If you are actually infected with the coronavirus, there is a good chance that the test will detect this. If you know that you are infected, you can quarantine yourself at home and protect your family, friends and colleagues from infection. You may also know a little earlier than usual if the disease is more severe. However, please note that even a negative test result does not mean that you can take distance and hygiene measures less seriously: You can still get infected at any time.

Submitting a saliva sample does not pose any risk to you. The vial is filled with sterile saline, so its contents are harmless. All materials supplied are food safe and can be stored without any special requirements.

Some people may find it uncomfortable to give the saliva sample for this study. There is a small risk of short-term discomfort. In rare cases, the participants report slight nausea shortly after gargling or a briefly blocked nose after clearing their throat.

The study is being carried out by a team from Heidelberg University as part of the National Research Network of University Medicine on Covid-19. We are also supported by the local health authorities. The study is financed by the Federal Ministry of Education and Research (thus indirectly by the taxpaying citizens).

Everyone who is sent a test tube is invited to take part in the study. A prerequisite for participation is your declaration that you feel sufficiently informed by the explanations given here and that you agree to the procedure described.

We, the Heidelberg University team, have asked all communities in the Rhine-Neckar region for addresses for the study via the public health department. Your address was selected randomly. We use the address data only to contact you and to assign the saliva samples to the persons; your data will not be passed on. The saliva samples are processed only using the codes (this is called pseudonymization) attached to the test tubes. The positive results are also transmitted in a pseudonymized manner to the public health department. There, a single authorized data officer has the option to trace back the coes to the actual names, telephone numbers, and email addresses. The transmission of positive cases is necessary because COVID-19 is a notifiable disease. The scientific analyses carried out at the university occur only using the pseudonymized codes.

Dr. Simon Anders, Center for Molecular Biology at the University of Heidelberg (ZMBH),
Im Neuenheimer Feld 324, 69120 Heidelberg

The collection, storage and processing of your data is carried out according to the data protection regulations of the “Art 6. §1” of the German data protection law (DSGVO) and the data protection standards of the European Union. Your contact data will only be used to contact you for study recruitment purposes. Once we have received the saliva samples and the test results are available, a very small number of participants will be contacted again and asked about their experiences. Afterwards, your data will be pseudonymized, i.e. all names, address data, and (if available) telephone numbers and e-mail addresses will be removed from your data set. Only the public health department can access this data in case of a positive test result, to contact you. All scientific analyses are carried out using the pseudonymized data. A human genetic analysis will not be performed. We only use the coronavirus gene snippets in your saliva sample.

If you do not want to take part in this study, your contact details (name, address and, if applicable, telephone number and email address) will be deleted from our directory at the end of the study. No medical findings will be collected during the study. The address data is stored in a database that is only accessible to the authorized data officers at the university and the local health authorities. In addition, information on the place, date and time of issue of the test tube is collected, which is linked to the code issued on the test tube. To report to the health department in the event of a positive test result, we will also ask for your telephone number and / or email address. The study management will take all reasonable steps to ensure the protection of your data in accordance with the data protection standards of the European Union. The data is encrypted and secured against unauthorized access. The names, address data, telephone numbers and e-mail addresses collected during the study will be destroyed after completion of the study.

All research data can also be used in future studies on coronaviruses and other respiratory viruses and / or published in scientific journals.
There is no sequencing of the human genome. The saliva samples are destroyed after the test results are available. The stored data will not contain any information that will identify you as a participant in this study. The data are protected from unauthorized access. You can refuse the use of your data for future research purposes in connection with coronaviruses or other respiratory viruses in the declaration of consent.

You have the right to request information about your stored personal data from the person responsible (see below). You can also request the correction of incorrect data and the deletion of the data or the restriction of their processing.

The person responsible for the study-related collection of personal data is:

Dr. Simon Anders, Center for Molecular Biology at the University of Heidelberg (ZMBH),
Im Neuenheimer Feld 324, 69120 Heidelberg

If you have any concerns about data processing and compliance with data protection requirements, you can contact the following data protection officer at the facility:

Universitätsklinikum Heidelberg, Datenschutzbeauftragte(r) Im Neuenheimer Feld 672, 69120 Heidelberg

Tel: 06221 56 70 36
E-Mail: datenschutz@med.uni-heidelberg.de

In the event of unlawful data processing, you have the right to complain to the following supervisory authority:

The State Commissioner for Data Protection and Freedom of Information Baden-Württemberg

Postfach 10 29 32, 70025 Stuttgart

Tel: 0711 61 55 41 – 0, Fax: 0711 61 55 41 – 15, E-Mail: poststelle@lfdi.bwl.de
Internet: www.baden-wuerttemberg.datenschutz.de

Participation is voluntary and free. Unfortuntately, any reimbursement or payment is not possible. If you would like to take part in the study, please ask your parents / guardians to sign the declaration of consent for you. You can revoke this consent at any time in writing or orally without giving reasons and without incurring any disadvantages. If you withdraw your consent, your personal data will be deleted so that the result of your sample can no longer be assigned to you. If you withdraw from the study, any material you have already gained can be destroyed. If your sample has already been analyzed, e.g. B. because you reported too late and the test result is positive, we will still transmit the code of the sample to the health department, as we are obliged to do so by law. If you do not want to participate, just don’t fill out the form and throw away the test tube.

For further information as well as for information about general results and the outcome of the study, as head of the study Dr. Andreas Deckert (contact via the telephone directory of the study on 06221 522 - 2399 or email: info@virus-finder.de ).

Study website: www.virus-finder.de
Phone assistance: 06221 522 – 2399

Monday through Friday from 7-11 am and 2-6 pm
The hotline is in operation from 18.11.2020 until 23.12.2020.

We would be very grateful for your participation in this important research project!

Information for children

You have probably heard of the new coronavirus!

We are doing a study about it and children from 7 to 11 years of age are also allowed to participate. The study is called: Study on corona test strategies for the general population.

That sounds complicated, but actually it isn’t. If you read on here, you will find out more.

What is a study anyway? In a study, scientists try to find out something, for example about diseases. We do research in laboratories and do a lot of different tests to learn how to help sick people and how to prevent healthy people from getting sick. So that we can research, we need samples.

We are scientists from the University of Heidelberg, researchers from biology and medicine, biochemists, virologists and doctors. We want to collect samples so we can find out more about this new coronavirus. You will find our names and addresses at the end of this text. You can even call us if you have any questions. But first read on.

The coronavirus is the reason why you couldn’t go to school in the spring. We would like to know who was infected with it and how such an infection can happen at all. Then maybe we can prevent this from happening so often and having to close all schools again. Then hopefully the cinemas, sports halls, theaters and restaurants can stay open.

Quite simply, you let us test you for the virus, that is, you do a Corona test. Surely you have heard of that? Maybe you’ve already done one? Did a doctor, nurse or nurse stick a cotton swab deep into your nose? That was certainly uncomfortable. It’s different with us: we spit on it! Why? Because our test works with spit.

For our test you also have to gargle a little and then spit everything out, nothing more. It is actually quite simple. That may sound disgusting to you when we examine your spit, but we scientists are used to even more disgusting samples. It is exciting for us to find out whether the virus is in it. And because we are scientists, we also want to try new methods to find out. Which will hopefully be even better. And you can help us with your spit.

You have probably heard a lot about it. So here just very briefly: Have you ever had a sore throat lately? Or a little fever? That could have been the coronavirus but it could also have been a normal cold. Nothing more happens to the vast majority of children when they catch the virus. The children have it good there; the virus can also be very dangerous in old and sick people. So we want to find out who has the virus in order to stop it.

If you want to find out more about the virus: Then ask your parents or maybe a teacher if they can tell you more about it. There are also great videos on the internet where you can learn a lot more, such as: B. what you already know about the spread of corona and what to do if someone has the corona virus.

You can find videos on the coronavirus under these links:

If you are reading this right now, you can join in. You were given a test tube and a small plastic bottle with some salt water. You can gargle with it and then use a straw, which is also included, to put the salt water and spit back into the bottle. Then you have to close the bottle tightly again and shake it very vigorously. Now all you have to do is pour a bit of your well-mixed spit into the little tube with the lines on the side. This is the sample tube. The scientists need these tubes for the test. The small tube fits directly into our machine, in which we measure whether there is the coronavirus in your sample. You’ll need to cut off the tip of the vial with scissors, and then carefully pour the spit into the small tube. Do not fill it too full and close it well at the end, otherwise the tube will leak and that would be a shame. Please ask your parents if they can help you if you are unsure.

All right? You can also watch the short video that we made about it or check our little cartoon. You can find the video here. It is best to have a look at it together with your parents, then they can help you too and you know immediately what to do.

The best thing to do is to do this with the test tube in the morning before breakfast and before brushing your teeth. We are not interested in what you had for breakfast or what kind of toothpaste you use. The test works best when we don’t have it in the sample. And one more thing: If you don’t feel like it, you don’t have to take part in the test. That is up to you to decide.

Now the little tube has to make it to our laboratory as quickly as possible. For that there are different possibilities. But your parents will take care of that. But they mustn’t forget that, please tell them.

In the laboratory, the scientists examine your sample. They use so-called molecular biology techniques to detect parts of the coronavirus. Let’s say they do find the virus in your sample, then what?

Then of course they will let you know. And for you it means: stay at home and wait until the virus is gone. This almost always goes away very quickly with children, and just a few days after the cough or fever has gone, there is so little left of the virus that you can no longer infect anyone with it. But what exactly you have to do will be told by the staff of the scientists - in any case, you must first stay at home for a few days. And if you’ve ever had the virus, you’re immune to it for at least a while. That’s not bad either. How long, however, is another question that we still have to investigate because we do not yet know the exact answer.

Lucky you! Because at least on the day we checked your saliva, there was no coronavirus in it. But as I said, the virus comes and goes - that means you might get the virus on another day. The good thing is that you can avoid that: if you carefully follow the rules, with mask, distance, hand washing and everything like it is said at school, then you are less likely to get infected. And maybe we scientists will find a way how we can relax these hygiene and distance rules without increasing the risk of infection. For example because people now know better whether they have the Coronovirus and are so careful during this time that they do not infect anyone.

Our corona test is all about whether the people’s saliva samples contain the corona virus or not. That is why the sample bears a number and not your name - and when we work with the sample we don’t even know who the sample comes from. Only if we find the virus in it can we give the number to a doctor. They can then look up who you are in a database in which your address is stored in encrypted form. The doctor will contact you to tell you what to do now. But as I said, most people don’t have the coronavirus - so there’s a good chance you’ll never hear from them (which is a shame because they’re nice and can answer all of your questions).

What happens to your sample then? After we know whether your saliva sample contains coronavirus or not, we just throw it away.

We need to know if you agree that we can examine your saliva for the coronavirus. If you agree, your parents can sign it for you.

The study is being carried out by a team from Heidelberg University. You can find a list of the participating scientists here: (www.virus-finder.de). We are also supported by the local health authorities. As explained above, they receive the contact details and inform people with a positive test result. The study is funded by the Federal Ministry of Education and Research.

For further information as well as for information about general results and the outcome of the study you can talk to Dr. Andreas Deckert (contact via telephone information for the study on 06221 522 - 2399 or email:
info@virus-finder.de)

You can also get information on the study website and from our telephone directory for the corona research study.

Study website: www.virus-finder.de
Phone assistance: 06221 522 – 2399

Monday through Friday from 7-11 am and 2-6 pm
The hotline is in operation from 18.11.2020 until 23.12.2020.

We would be very grateful for your participation in this important research project!

Information for parents and legal guardians of children aged 7-11

Dear parents, dear legal guardians,

We, the Heidelberg University Hospital, would like to invite you/your child to participate in our coronavirus research study. The study is funded by the German Federal Ministry of Education and Research, conducted by a team from Heidelberg University within the National Research Network of University Medicine on Covid-19 and supported by the local health authorities. This information sheet explains the purpose of this study, in which participants from the age of 7 can participate.

The novel coronavirus SARS-CoV-2 has presented us with major challenges in recent months due to the pandemic. Currently, we are responding to rising case numbers by imposing coronavirus prevention measures (e.g. lockdown). The main reason is that people without symptoms can also pass on the virus and thus public health initiatives as implemented at the moment cannot respond in time. This would require a strategy that can also detect persons with asymptomatic infections at an early stage. We are testing a procedure that can solve this problem and ask you for your voluntary assistance.

Your child was randomly selected from the addresses of your community and randomly assigned to one of the 4 strategies that we want to test as part of a corona research study. Because the study takes place in the public interest information from the register of residents was released according to Section 46 of the Federal Registration Act. The Institute for Global Health at Heidelberg University carried out the random selection together with the Leibniz Institute for Social Sciences in Mannheim (GESIS). The ethics committee of the University of Heidelberg had no legal objections to conducting the study. Data protection regulations are complied with (more about data protection ).

Similarly, assignment to one of four testing strategies was done randomly: We will compare (1) testing of individual people with (2) testing of all members of a household as well as unconditional testing with testing based on a questionnaire that asks for symptoms.

Usually only people who have Covid-19 symptoms, or who are at risk, are asked to go to their family doctor for a throat swab. A healthcare professional uses a cotton swab through the mouth or nose to the back of the throat and swabs material (secretions and cells). The sample is then tested in a medical laboratory for the presence of coronavirus.

This laboratory technique is called “qPCR”.

We want to test randomly selected people from the general population, so that we can also detect persons infected with coronavirus without/with early symptoms. We will use two approaches:

  1. We want to take saliva samples instead of conducting a throat swab. This has several advantages:
    a) Doing a throat swab is quite unpleasant. Spitting into a small tube is much more pleasant and also easier.
    b) You can easily take a saliva sample yourself with your child at home. In the instructions in the brochure from page 54 and a short video on www.virus-finder.de we explain to you and your child how to proceed.
  2. We would also like to use a different analysis method in the laboratory.
    Instead of the usual “qPCR” method, we use a newly developed alternative called “LAMP” which is technically much simpler. Both laboratory methods are not perfect: If the samples contain only a few viruses, they can miss an infection.
    The LAMP method is currently still a research method that has been greatly improved in recent months, so that it is now as sensitive as the usual “qPCR” procedure. However, one does not have that much experience with the LAMP method. That is why a negative result of an RT-LAMP reaction is a little less reliable than a result determined with the established qPCR method. However, we can identify infectious people very well with the LAMP test and in some cases detect the virus well for 1 to 2 weeks after Covid 19 patients no longer have symptoms. We can also detect the virus well 1 to 2 days before symptoms develop: With the same laboratory capacity and the same number of laboratory technicians, we are able to test a lot more people than would be possible with the qPCR test.

A good overview with resources about qPCR and alternative testing methods can be found on our link list: www.virus-finder.de/links

First of all, you should read this information sheet carefully and consider whether you agree with everything and would like to participate in the corona research study. We have prepared a child-friendly information leaflet for your child (see pages 32-39 of this brochure) which your child should read if possible. Please then talk to your child about the study and ask your child if they would like to take part in the study. If this is the case, we ask you to sign the attached declaration of consent for your child. Please include your telephone number or email address so that you can contact the health department in the event of a positive test and discuss further measures.

  1. Keep the access code on the top right of the cover letter, you will need it to retrieve your test results on the Internet or on the phone.
  2. We will then ask your child to provide a saliva sample. You and your child can find the instructions for the saliva sample from page 54 in this brochure or in a short video at www.virus-finder.de.

    IMPORTANT: If possible, your child should take the saliva sample before breakfast and before brushing your teeth. This will allow for greater accuracy.

  3. Finally, send us the tube together with the declaration of consent (if you have also received a questionnaire and filled it out, this too, if possible) by post free of charge. The return must be made with the enclosed return envelope suitable for sending samples. You can find instructions on our website www.virusfinder.de and in the cover letter.

    IMPORTANT: Please take your sample during the week (Monday through Friday) and send it off via mail on the same day, if possible.

    Participating in the Corona research study should take you and your child between 10 and 20 minutes.

If we can detect the coronavirus in your child’s sample with our test (positive result), you will receive a preliminary result and we will check the result again with the established qPCR method (confirmatory test). You do not need to take a throat swab for this, we will also perform this analysis with the saliva sample you already have submitted. If the qPCR test is also positive, we will inform the public health department about the test result. This is necessary because COVID-19 is a notifiable disease. The Health Department will then contact you and inform you about the confirmed positive test result and about further measures. Typically, the Health Department will ask your child to go into quarantine and work with you to identify the people your child may have been in contact with.

You can retrieve the result yourself on our website (www.virus-finder.de) or you can make an enquiry at the study’s information desk (Tel. 06221 522-2399, Monday to Friday 7 am-11pm and 2 pm-6pm). Even if it should be negative (no virus detected), that is not a complete all-clear! There is no one hundred percent accurate test. The test method used here is a research method, the accuracy of which has not yet been finally clarified. However, initial investigations indicate that the accuracy is in the range of the established qPCR method. Even if your child was not infected when the saliva was sampled, that does not mean that they may not have become infected a short time later. Or your child was infected shortly before, but the virus had not yet reproduced enough to be detectable. The test only provides information about the current situation at the time the sample was taken. Therefore, this test does not in any way release the public from the public hygiene and protective measures, and we ask you to continue to carefully observe these with your child.

Everyone who participates in the study supports the aim of managing the pandemic situation in Germany for the long term and may help to avoid further large-scale restrictions in public life.

If your child is actually infected with the coronavirus, there is a good chance that this will be detected with the test. If you know that your child is infected, you can put your child in quarantine at home and thus protect your family, friends, classmates, teachers and other people from infection. In addition, you may know a little earlier than usual what is wrong with your child if the illness should become more severe. If the test result is negative, this unfortunately cannot give you and your child a “carte blanche” to take the rules of distance and hygiene less seriously. You and your child can still become infected at a later point.

Submitting a saliva sample does not pose any risk for your child. The vial is filled with sterile salty water, so its contents are harmless. All materials supplied are food safe and can be stored without any special requirements.

Some people may find it uncomfortable to give the saliva sample for this study. There is a small risk of short-term discomfort. In rare cases, the participants report slight nausea shortly after gargling or a briefly blocked nose after clearing their throat.

The study is conducted by a team from the University of Heidelberg within the National Research Network of University Medicine on COVID-19. We are also supported by the local health authorities. The study is funded by the Federal Ministry of Education and Research and thus by all of you, the tax-paying citizens - thank you very much.

Everyone who is sent a test tube is invited to take part in the study. A prerequisite for participation is your declaration that you feel sufficiently informed by the explanations given here and that you agree to the procedure described.

We, the Heidelberg University team, have asked all communities in the Rhine-Neckar region for addresses for the study via the public health department. Your address was selected randomly. We use the address data only to contact you and to assign the saliva samples to the persons; your data will not be passed on. The saliva samples are processed only using the codes (this is called pseudonymization) attached to the test tubes. The positive results are also transmitted in a pseudonymized manner to the public health department. There, a single authorized data officer has the option to trace back the codes to the actual names, telephone numbers, and email addresses. The transmission of positive cases is necessary because COVID-19 is a notifiable disease. The scientific analyses carried out at the university occur using only the pseudonymized codes without the possibility to trace them back to the original names or addresses.

Dr. Simon Anders, Center for Molecular Biology at the University of Heidelberg (ZMBH),
Im Neuenheimer Feld 267, 69120 Heidelberg

The collection, storage and processing of your data is carried out according to the data protection regulations of the “Art 6. §1” of the German data protection law (DSGVO) and the data protection standards of the European Union. Your contact data will only be used to contact you for study recruitment purposes. Once we have received the saliva samples and the test results are available, a very small number of participants will be contacted again and asked about their experiences. Afterwards, your data will be pseudonymized, i.e. all names, address data, and (if available) telephone numbers and e-mail addresses will be removed from your data set. Only the public health department can access this data in case of a positive test result, to contact you. All scientific analyses are carried out using the pseudonymized data. A human genetic analysis will not be performed. We only use the coronavirus gene snippets in your saliva sample.

If your child does not want to take part in this study, your contact details (name, address and, if applicable, telephone number and email address) will be deleted from our directory at the end of the study. No medical findings will be collected during the study. The address data is stored in a database that is only accessible to the authorized data officers at the university and the local health authorities. In addition, information on the place, date and time of issue of the test tube is collected, which is linked to the code issued on the test tube. To report to the health department in the event of a positive test result, we will also ask for your telephone number and / or email address. The study management will take all reasonable steps to ensure the protection of your data in accordance with the data protection standards of the European Union. The data is encrypted and secured against unauthorized access. The names, address data, telephone numbers and e-mail addresses collected during the study will be destroyed after completion of the study.

All research data can also be used in future studies on coronaviruses or other respiratory viruses and / or published in scientific journals. There is no sequencing of the human genome. The saliva samples are destroyed after the test results are available. The data retained will not contain any information that will identify your child as a participant in this study. The data are protected from unauthorized access. You can opt out of the use of your child’s data for future research purposes in connection with coronaviruses or other respiratory viruses in the declaration of consent.

You have the right to request information from the person responsible (see below) about your child’s stored personal data. You can also request the correction of incorrect data and the deletion of the data or the restriction of their processing.

The person responsible for the processing of your personal data is:

Dr. Simon Anders, Center for Molecular Biology at the University of Heidelberg (ZMBH),
Im Neuenheimer Feld 267, 69120 Heidelberg

If you have any questions regarding data processing and compliance with data protection requirements, you can contact the following data protection officer at the institution:

Universitätsklinikum Heidelberg, Datenschutzbeauftragte(r)
Im Neuenheimer Feld 672, 69120 Heidelberg

Tel: 06221 56 7036
E-Mail: datenschutz@med.uni-heidelberg.de

Im Falle einer rechtswidrigen Datenverarbeitung haben Sie das Recht, sich bei der folgenden Aufsichtsbehörde zu beschweren:

The State Commissioner for Data Protection and Freedom of Information Baden-Württemberg

Postfach 10 29 32, 70025 Stuttgart

Tel: 0711 61 55 41 – 0, Fax: 0711 61 55 41 – 15,
E-Mail: poststelle@lfdi.bwl.de
Internet: www.baden-wuerttemberg.datenschutz.de

Participation is voluntary and free. Unfortunately, it is not possible to pay any compensation for expenses which may have occurred. If your child would like to participate in the study, we ask you to sign the consent form. You can revoke this consent at any time in writing or verbally without explanation and without incurring any disadvantages. If you do so, your personal data will be deleted, so that the result of your sample can no longer be attributed to you. If you withdraw from the study, materials already obtained can be destroyed upon request. However, if your sample has already been analyzed the test should prove positive, we will still transmit the code of the sample to the public health department, as we are obliged to report. If you do not wish to participate, simply do not fill out the form and throw the test tube away.

For further information as well as for information about general results and the outcome of the study please contact the head of the study Dr. Andreas Deckert (contact via the telephone directory of the study on 06221 522 - 2399 or email: info@virus-finder.de ).

In addition you can find information on the study website and via the telephone hotline.

Study website: www.virus-finder.de
Phone assistance: 06221 522 – 2399

Monday through Friday from 7-11 am and 2-6 pm
The hotline is in operation from 18.11.2020 until 23.12.2020.

Wir wären Ihnen und Ihrem Kind für die Teilnahme an diesem wichtigen Forschungsprojekt sehr dankbar!

Important: Please carry out the test on weekdays (Monday to Friday) and return the sample on the same day!

Please take the test sober, i.e. before breakfast and brushing your teeth . You may want to go to a separate room.

Open the test kit consisting of a little bottle containing saline, a tube and a straw.

Open the bottle containing the salt solution.

Fill the salt solution from the little bottle into your mouth. Do not swallow .

Gargle vigorously with the salt solution for at least 30 seconds .

Spit the gargle liquid from your mouth back into the bottle , use the straw to help.

Thoroughly clear your throat for 30 seconds to remove mucus and secretions from your nose and throat. Cough vigorously several times and sniff up your nose!

Repeat points 7 and 8 for about 30-60 seconds.

Spit back these secretions into the bottle using the straw.

As soon as the gargled liquid + secretions are back in the bottle, close it tightly .

Shake bottle vigorously for about 30 seconds.

Open the cap of the bottle and remove the tip with scissors .

Open the screw cap of the small tube with the barcode on it.

Pour a bit of the gargled liquid into the tube until it is maximum 3/4 full.

Next, close tube tightly.

Place the tube with the barcode in the marked return bag next to the yellow fleece.

Stow several samples in the compartments of the yellow fleece and in the return bag .

Then seal the bag with the sample or samples and the inner fleece.

Wash out the bottle and dispose of it with the straw in the recycling or household waste.

Put the declaration of consent with the sealed sample bag in the return envelope .

Put the declaration of consent with the sealed sample bag in the return envelope .

Close the return envelope. Please do not forget to put down the sender address .

Throw the stamped return envelope into the nearest mailbox.

Shipping is free of charge .

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