Evaluation of the clinical performance of the enzyme-linked immunosorbent assay RIDASCREEN® TB and the immunochromatographic lateral flow assay RIDA®QUICK TB in human plasma samples

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036207

Enrollment

350

Registered

2025-02-20

Start date

2024-03-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A15-A19

Interventions

Group 1: Patients with an active tuberculosis, confirmed by clinical symptoms and positive culture, PCR or radiological or microbiological results. Patients with latent oder inactive Tuberculosis, con

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Ability to understand a written subject information and informed consent form • Signed informed consent form • Females and males 18 years of age and older • Collection of the required volume of whole blood possible • Patients providing blood for other reasons than the clinical study • Plasma samples frozen at -80°C TB positive subjects: • Active tuberculosis diagnosis confirmed by cultural detection. • Between blood sampling and positive culture result, not more than six weeks TB negative subjects: • No known contact with TB positive subjects • No immunological evidence of infection • No (self-)reported travel history in endemic regions

Exclusion criteria

Exclusion criteria: • pregnant and breastfeeding • Patients under 18 years of age • Patients that refuse to provide data on their history in the context of TB contact or infections • Any event, which, in the opinion of the investigator, makes the specimen unsuitable for entry into the study. Any specimens identified as unsuitable for entry into the study shall be identified and the investigator shall record the rationale for exclusion

Design outcomes

Primary

Measure	Time frame
To evaluate clinical performance characteristics of RIDASCREEN® TB and RIDA®QUICK TB for the detection of interferon gamma induced Protein 10 (IP-10) in human plasma of patients with active Mycobacterium tuberculosis infection and patients without symptoms and history of close contact to active TB patients.	—

Secondary

Measure	Time frame
To evaluate clinical performance characteristics of RIDASCREEN® TB/ RIDA®QUICK TB for the detection of IP-10 in human plasma of those subjects as compared to QuantiFERON®-TB Gold Plus	—

Countries

Germany

Contacts

Public ContactHannah Gören

R-Biopharm AG

h.goeren@r-biopharm.de+49 6151 8102 - 7277

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026