Collection of blood samples for research and development of an IP-10 TB-CLIA-Assay

Recruiting

Conditions: A15-A19
Tuberculosis

Registration Number: DRKS00030861

Lead Sponsor: R-Biopharm AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 200

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

•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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1) Collection of important clinical and phenotypic data, for better characterization of the above mentioned samples <br>2) Comparison of the results of the CLIA technology with the results of the IP-10 ELISA and Lateral Flow Assay<br>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<br>4) Use of blood samples for the continuous product improvement process of the TB test assays in the area of R&D