A15-A19
Conditions
Sponsors
R-Biopharm AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the proposed study is to collect blood samples for performance evaluation of the products. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to. 1. determine the correlation between RIDASCREEN® TB and RIDA®QUICK TB 2. determine the correlation between RIDASCREEN® TB and QuantiFERON-TB Gold Plus (QIAGEN) | — |
Countries
Germany
Contacts
Public ContactHannah Gören
R-Biopharm AG
Outcome results
None listed