Antecedentes
Multidrug-resistant tuberculosis requires accurate identification of both Mycobacterium tuberculosis complex and antimicrobial resistance-associated markers. In automated molecular workflows, system verification is essential to confirm that the full analytical process performs correctly, from sample processing and nucleic acid extraction to amplification, detection, and interpretation of resistance targets.
Laboratories implementing or verifying MDR-TB assays need external controls that appropriately represent relevant resistance profiles and can be processed in the same manner as clinical specimens. This supports assessment of the complete analytical workflow and increases confidence in the simultaneous detection of tuberculosis and resistance-associated mutations.
Product information
AMPLIRUN® TOTAL MDR-TB Verification & Control Panel is an external sputum control panel developed and validated for the BD MAX™ MDR-TB assay. It is designed to support verification and quality control of automated molecular workflows for the detection of Mycobacterium tuberculosis and mutations associated with resistance to rifampicin and isoniazid.
The panel includes 10 vials:
- 2 vials of Mycobacterium tuberculosis
- 2 vials of rifampicin-resistant Mycobacterium tuberculosis with the rpoB S531L mutation
- 2 vials of rifampicin-resistant Mycobacterium tuberculosis with the rpoB H526D mutation
- 2 vials of isoniazid-resistant Mycobacterium tuberculosis with the katG S315T mutation
- 2 vials of isoniazid-resistant Mycobacterium tuberculosis with the inhA C15T mutation
AMPLIRUN® TOTAL controls are formulated as complete inactivated microorganisms in a sample-like matrix, allowing laboratories to monitor the full analytical process. Their quantified, lyophilized, monodose format supports assay verification and external control standardization in molecular workflows for drug-resistant tuberculosis.
PRODUCTS
AMPLIRUN® TOTAL MDR-TB VERIFICATION & CONTROL PANEL
Analytes: Mycobacterium tuberculosis
HOW IT WORKS
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