This project is being carried out by the Institute of Infectious Diseases and Tropical Medicine at the LMU Hospital. In the course of this study, we are investigating the Tropical Institute's own questions and are also working with industrial partners on the development of new diagnostic tests for tuberculosis.

The aim of common tests for tuberculosis is to detect the bacterium directly. It is not always possible to reliably detect the disease with existing tests, and they are often time-consuming to obtain a reliable result.

There are blood tests that show whether a person has already had contact with the tuberculosis bacterium (interferon gamma release assays, IGRA for short). However, these tests cannot distinguish between tuberculosis disease, a latent tuberculosis infection or merely a long-standing contact of the immune system with the bacterium.

An active tuberculosis disease can be cured by administering antibiotics, which also prevents the infection of other people - so rapid diagnosis and treatment is important.

The main objective of this study is to identify highly sensitive and specific biomarkers, i.e. substances in blood, urine or saliva, for the diagnosis of tuberculosis disease. This study serves as a platform for the collection of samples for the discovery of new diagnostic markers for both tuberculosis disease and latent tuberculosis infection.

We are looking for different groups of people for the study in order to generate the most meaningful results possible.

We are looking for interested people who fall into one of the following categories:

• Already proven contact with tuberculosis (infection, IGRA-positive)
  

OR

• Have not had any contact with tuberculosis patients or have ever traveled to a tuberculosis area or been outside Europe (IGRA-negative)
  

OR

• Suffered from tuberculosis 6-12 months ago and have since been treated

If you fall into one of these categories, are at least 18 years old, in good health and not pregnant, you can take part in the study.

If you do not have a current IGRA test result, we will take a blood sample as part of the study to carry out a free IGRA test on you.

Participation in our study is of course voluntary. It involves a single visit to a study center, where we will first provide you with detailed information about the study and its objectives. We will then ask you specific questions about your health status and living conditions. You will also have saliva, urine and blood samples taken. This study appointment will take approximately one hour. Please note that the study appointments take place between Monday and Thursday mornings.

If you do not have a current IGRA test result, we will take a blood sample during the study to carry out a free IGRA test on you.

Blood sampling as part of the study (venipuncture, single-use cannula) involves very low risks at best. In rare cases, bleeding into the surrounding tissue (haematoma), in very rare cases phlebitis, a blood clot, injury to a cutaneous nerve and/or infection can be triggered.

The collection of urine and saliva samples does not involve any risks for you.

There is no direct personal therapeutic benefit for you in connection with the study. However, your participation will be of considerable benefit to the general public and will simplify the diagnosis of tuberculosis in the future. You will receive an expense allowance of 50 euros for your time.

Please note that enrollment for this study has been completed. Thank you for your interest and for your understanding.

Aim of the study

Research into new biomarkers in order to be able to diagnose tuberculosis more easily and quickly.

Study schedule

• One study appointment (appointments from Monday to Thursday mornings)
  
• Blood, urine and saliva sample
• An expense allowance of 50€

General requirements for participation:

• At least 18 years of age
• In good health
• You are not pregnant

You fall into one of the following categories

• You have already had proven contact with tuberculosis (infection, IGRA-positive) OR

• You have not had any contact with tuberculosis patients (IGRA-negative) or have ever traveled to a tuberculosis area before (= have not been outside Europe)