Collection of blood samples for the evaluation of the analytical performance of two new in vitro test systems for tuberculosis diagnostics

Recruiting

Conditions: A15-A19
Tuberculosis

Registration Number: DRKS00027129

Lead Sponsor: R-Biopharm AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 636

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of the proposed study is to collect blood samples for performance evaluation of the products.

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to. <br>1. determine the correlation between RIDASCREEN® TB and RIDA®QUICK TB <br>2. determine the correlation between RIDASCREEN® TB and QuantiFERON-TB Gold Plus (QIAGEN)