DRKS00027129
Recruiting
Not Applicable
Collection of blood samples for the evaluation of the analytical performance of two new in vitro test systems for tuberculosis diagnostics - TID-2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- A15-A19
- Sponsor
- R-Biopharm AG
- Enrollment
- 636
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to understand a written consent form
- •\- Signed consent form
- •\- Women and men 18 years and older
- •\- Collection of the required volume of whole blood possible
- •TB positive subjects only
- •\- Active or latent Mycobacterium tuberculosis infection. Active tuberculosis diagnosis confirmed by clinical symptoms and molecular detection (by PCR) or by cultural detection or microscopic detection of the pathogen or by radiological examination. Latent TB infection confirmed by interferon\-gamma release assay (IGRA) or tuberculin skin test.
- •TB\-negative subjects only
- •\- No clinical or pathologic test results or medical history suggestive of active or latent Mycobacterium tuberculosis infection
Exclusion Criteria
- •\- Pregnant and breastfeeding women
- •\- An event/findings due to which, in the opinion of the investigator, the subject is not suitable for participation in the study
- •\- Body weight \< 65 kg with blood collection volume greater than 70 ml.
- •\- TB\-positive subjects: Hemoglobin level \< 13\.5 g/100 ml with blood collection volume greater than 70 ml
Outcomes
Primary Outcomes
Not specified
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