A research project for the development of a new in-vitro diagnostic test for tuberculosis.
- Conditions
- A15Respiratory tuberculosis, bacteriologically and histologically confirmed
- Registration Number
- DRKS00014254
- Lead Sponsor
- R-Biopharm AG
- Brief Summary
The goal of developing a test system for the qualitative detection of M. tuberculosis infection was achieved. Based on the evaluation of the collected blood samples, it could be shown that a TB specific release of IP-10 was achieved as soon as the sample comes into contact with the peptides.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 547
Inclusion Criteria
TB-infected participants
- Signed informed consent
- Age over 18 years
- TB-disease confirmed with clinical symptoms and PCR, culture, radiology or microscopy.
- Willing and able to donate 50mL blood
Exclusion Criteria
- Any condition or disorder that in the opinion of the investigator will make the participant inappropriate for study participation.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method As part of the study, it will then be determined whether the determination of the immunological concentrations and the proposed evaluation algorithm are appropriate to differentiate the groups involved - participants subjects with a previous tuberculosis infection and participants subjects without a known infection.<br>
- Secondary Outcome Measures
Name Time Method