Serological Test for the Diagnosis of TB

Performances of Immunoassays Based on the Detection of Antibodies Directed Against Mycobacterium Tuberculosis Antigen for the Diagnosis of Active Tuberculosis in Adults

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02898623

Acronym

MycoTB

Enrollment

1000

Registered

2016-09-13

Start date

2013-12-20

Completion date

2015-06-20

Last updated

2021-12-10

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

Conditions

Active Tuberculosis

Brief summary

TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB. The main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. Adult patients with possible TB from will be tested for the presence of antibodies directed against M. tuberculosis selected antigens. Positive and negative predictive values will be established based on TB culture results.

Interventions

OTHERNo intervention

Evaluation of performance of immunoassays based on the detection of antibodies directed against Mycobacterium tuberculosis antigen

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Signs of possible Tuberculosis (TB); testing for TB in routine practice (microbiology)

Exclusion criteria

* Immunosuppression

Design outcomes

Primary

Measure	Time frame
Positive and negative predictive values for the diagnosis of active TB	48 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026