Tuberculosis test kit cobas® MTB

mycobacterium tuberculosis complexMycobacterium tuberculosissputum

Overview
cobas® MTB is an automated qualitative in vitro diagnostic real-time PCR assay for direct detection of Mycobacterium tuberculosis complex (MTBC) DNA in human respiratory specimens, including raw sputum, NALC‑NaOH digested/decontaminated sputum and bronchoalveolar lavage (BAL). It is intended to support diagnosis of pulmonary tuberculosis in patients not receiving antituberculosis therapy.

Intended use
Automated qualitative detection of MTBC DNA in respiratory specimens to aid diagnosis of pulmonary tuberculosis in suspected patients not on antituberculosis treatment. For in vitro diagnostic use only.

Key features and workflow
Integrated workflow combines pre‑analytic liquefaction and inactivation, sonication, automated nucleic acid extraction/purification, PCR amplification and real‑time detection on cobas® 5800/6800/8800 systems.

• Pre‑analytic: simultaneous sample liquefaction and mycobacterial inactivation using cobas® Microbial Inactivation Solution (MIS).
• Sonication: applied to liquefied/inactivated samples prior to loading.
• Automated preparation: magnetic glass particle extraction (silica binding) with wash and heated elution steps.
• PCR and detection: real‑time amplification with target‑specific primers/probes; software assigns results as positive, negative or invalid.

Methodology and molecular details
Dual‑target amplification of MTBC sequences (16S rRNA and multiple esx regions: esxJ, esxK, esxM, esxP, esxW). An internal DNA control (DNA‑IC) is co‑amplified to monitor extraction and amplification. Master mix contains dUTP and AmpErase (uracil‑DNA glycosylase) for carry‑over control. Distinct fluorescent probes permit simultaneous real‑time detection of MTBC targets and DNA‑IC.

Specimen types and applications

• Validated specimen types: raw sputum; NALC‑NaOH digested/decontaminated sputum; bronchoalveolar lavage (BAL).
• Primary application: qualitative detection of MTBC DNA in respiratory specimens to aid pulmonary tuberculosis diagnosis.

Platform compatibility and data management
For use on cobas® 5800, cobas® 6800 and cobas® 8800 systems. The cobas® 5800 is an integrated instrument; cobas® 6800/8800 use modular configuration. System software performs automated result calling and provides review, export and reporting options.

Related kit information
Kit designation: KIT COBAS 58/68/8800 MTB 384T (1 kit = 384 tests). Reagents and components support pre‑analytic inactivation, extraction and PCR workflow as described.

Regulatory
For in vitro diagnostic (IVD) use.

Technical specifications

• Intended use: Qualitative detection of MTBC DNA in human respiratory specimens.
• Method: Real‑time PCR (dual‑target: 16S rRNA and esx gene regions).
• Sample types: Raw sputum; NALC‑NaOH digested/decontaminated sputum; BAL.
• Pre‑analytic: cobas® MIS liquefaction and mycobacterial inactivation; sonication prior to loading.
• Automated prep: Magnetic glass particle extraction (silica binding), wash and heated elution.
• Internal control: DNA‑IC co‑amplified to monitor processing and PCR.
• Contamination control: dUTP in master mix and AmpErase (uracil‑DNA glycosylase).
• Detection: Fluorescent dual‑probe detection with separate channels for MTBC targets and DNA‑IC; real‑time monitoring.
• Platform: cobas® 5800, cobas® 6800, cobas® 8800.
• Kit: KIT COBAS 58/68/8800 MTB 384T (1 kit = 384 tests).
• EAN: 00875197006605.