COBAS MTB

The cobas study is a collaboration between Roche Molecular Systems, Inc. as the sponsor, and RPRI together with INAVIMED as the implementing institutions in Indonesia. This study is a Clinical Performance Study (CPS), which primarily aims to assess the analytical and clinical performance of an investigational device under real-world conditions.

Information

The COBAS study is a collaboration between Roche Molecular Systems, Inc. as the sponsor, and RPRI together with INAVIMED as the implementing institutions in Indonesia. This study is a Clinical Performance Study (CPS), which primarily aims to assess the analytical and clinical performance of an investigational device under real-world conditions. A CPS typically evaluates how well the device detects the target analyte, compares its results with established reference methods, and determines its reliability, accuracy, and overall suitability for clinical use.

Roche Molecular System Inc. (Sponsor)
ICRC University of Washington (Collaborator)
Roche Indonesia (Collaborator)
Laboratorium Mikrobiologi RSUP
Persahabatan (Central Lab)
Puskesmas Wilayah DKI Jakarta (Lokus Penelitian)

Type of Study

Stakeholders Involved

Clinical Performance Study (CPS)

Background

Tuberculosis (TB) remains a significant public health burden in Indonesia. The laboratory diagnosis of TB disease involves testing for Mycobacterium tuberculosis (MTB) from respiratory specimens such as sputum to confirm the diagnosis. This study will support TB control and elimination efforts by improving the diagnosis of infection, including cases involving multi-drug-resistant TB, through the evaluation of an advanced molecular diagnostic platform.