LyteStar TB-MDR PCR Kit

For detection and differentiation of rifampicin and isoniazid-resistant tuberculosis DNA, in Mycobacterium tuberculosis positive human specimens

The LyteStar™ TB-MDR PCR Kit 1.0 is intended for the specific detection and differentiation of rifampicin and isoniazid resistance markers in Mycobacterium tuberculosis positive specimens from human sputum, bronchial washings, cerebrospinal fluid (CSF), urine, body fluids, tissue, and EDTA-whole blood. The LyteStar™ TB-MDR PCR Kit 1.0 is a dual-tube assay targeting the rpoB gene for the detection of rifampicin-resistant Mtb strains and the katG and inhA genes for the detection of isoniazid-resistant Mtb strains.

Specifications and Features

Dual Tube Assay for Detection and Differentiation:
Highest Analytical Sensitivity
RIF-resistance; rpoB gene
18.01 cp/μl
INH-resistance; katG and inhA genes
36.98 (katG) / 116.03 (inhA) cp/μl
Internal Control (IC); heterologous DNA

100% Analytical Specificity

  • The specificity of the kit was evaluated by testing genomic RNA/DNA extracted from other pathogens likely to be present in the same sample material as MTBC, or that cause similar symptoms to these bacteria.
  • No cross reactivity was observed with other pathogens, other than the intended target.

Clinically Validated

  • The clinical performance of the kit was evaluated through a retrospective study at a reference laboratory in comparison to the clinical site’s reference method.
  • In comparison to the reference test, all samples tested with 100% concordance.

Integrated Quality Monitoring

  • The kit includes a heterologous amplification system (Internal Control; IC) to identify possible PCR inhibition and to confirm the integrity of the reagents of the kit. The IC may also be used to monitor nucleic acid extraction efficiency.
  • A Positive Control (PC) with synthesized target genes of rifampicin-resistant and isoniazid-resistant M. tuberculosis DNA confirms the integrity and performance of the kit components.
  • A Negative Control (PCR-grade water) monitors potential contamination and excludes false positive results.

Convenience and Efficiency

  • Harmonized cycling profiles with selected other AstronDX products to perform analysis of multiple targets concurrently in the same PCR run.
  • Validated for use with various extraction kits and PCR cyclers – Please always refer to latest Instructions for Use (IFU).
  • 96 rxn and 24 rxn kit sizes accommodate various throughput scenarios, with Master reagents being provided in multiple tubes to reduce freeze-thaw cycles.
  • Ready-to-use reagents and an intuitive, uncomplicated pipetting scheme to minimize errors and guarantee efficient workflows and routine procedures.

Order Information

Product Name

LyteStar TB-MDR PCR Kit 1.0

Cat. No.     /     Reactions

870003                   96

870002                   48

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