AMPLIRUN® Total Mycobacterium Tuberculosis (MTB) Control

The amplirun® total mtb controls provide inactivated Mycobacterium tuberculosis (MTB) cells formulated to mimic human sputum specimens, designed as external quality controls for nucleic acid detection techniques. Each control contains the complete inactivated microorganism in a clinical-like matrix, ensuring end-to-end validation of the entire analytical workflow, from extraction to amplification and detection.

Supplied as quantified, low-positive, single-use lyophilized vials, these controls are safe, reproducible, and CE-certified, supporting reliable assay validation and long-term QC programs. Specific resistant strain panels are also available to verify INH (isoniazid) and RIF (rifampicin) resistance in molecular assays for drug-resistant tuberculosis.

Available Controls

Key Features

• Inactivated whole Mycobacterium tuberculosis cells – non-infectious, with inactivation certificate.
• Mimics human sputum specimens – provides clinically relevant sample matrix.
• Quantified low-positive controls – standardized for reproducibility and reliability.
• Validates the entire testing process: extraction, amplification, and detection.
• Resistant strain panels available – INH, RIF, and MDR-TB verification.
• Lyophilized, single-use vials – stable at ambient temperature, easy to handle.
• CE certified – compliant with quality and accreditation requirements.

Applications

• External QC for tuberculosis molecular diagnostic assays.
• Verification of assay sensitivity, specificity, and reproducibility.
• Validation of new commercial or in-house molecular tests.
• Long-term monitoring of instrument and reagent performance.
• Verification of resistance detection for INH, RIF, and MDR-TB strains.
• Training of laboratory staff and troubleshooting workflow errors.
• Compliance with laboratory accreditation standards (ISO/CE).

Product Details

The amplirun® total mtb controls are essential tools for laboratories performing molecular detection of Mycobacterium tuberculosis. By providing realistic, inactivated sputum-like specimens, they allow full-process validation, resistance verification, and ongoing QC monitoring. With CE certification and resistant strain panels (INH, RIF, MDR-TB), these controls support accurate diagnostics, regulatory compliance, and reliable TB testing in clinical and reference laboratories.