A15-A19
Conditions
Interventions
Group 1: One-Time collection of around 36 ml of whole blood from TB-positive donors (either actively or latently infected with TB)
Group 2: One-Time collection of around 36 ml of whole blood from TB-n
Sponsors
R-Biopharm AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General inclusion criteria: • Ability to understand and sign a written subject information and informed consent form • women and men over 18 years old • collection of the necessary volume of whole blood possible Only for TB-positive subjects • active or latent infection with tuberculosis • diagnosis of active tuberculosis: confirmed by clinical symptoms and molecular evidence (by PCR) or by cultural detection or by microscopic detection or by radiological examination • latent TB-infection: confirmed by IGRA or Tuberkulin skin test Only for TB-negative subjects • no clinical or pathological test result or anamnestic data indicating active or latent infection with M. tuberculosis
Exclusion criteria
Exclusion criteria: • pregnant or breastfeeding women • An event or finding, due to which the subject is not suitable for the participation in the study in the opinion of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection of venous whole blood samples for development of a chemiluminiscent immunoassay (CLIA), which, in combination of the already developed induction tubes (RIDA®TB Tubes), serves as a testing system of an infection with M. tuberculosis. The purpose of the CLIA is the quantitative detection of IP-10 from the previously induced plasma samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Collection of important clinical and phenotypic data, for better characterization of the above mentioned samples 2) Comparison of the results of the CLIA technology with the results of the IP-10 ELISA and Lateral Flow Assay 3) Usage of blood samples for R&D tests of RIDASCREEN®TB, RIDA®QUICK TB and RIDA®TB Tubes in the context of CAPA/Change measures 4) Use of blood samples for the continuous product improvement process of the TB test assays in the area of R&D | — |
Countries
Germany
Contacts
Public ContactThomas Rössler
R-Biopharm AG
Outcome results
None listed