LyteStar TB/NTM PCR Kit

For detection and differentiation of the Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM) DNA from human specimens

The LyteStar™ TB/NTM PCR Kit 3.1 is intended for the simultaneous and specific detection of Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM) DNA in human sputum, bronchial washings, cerebrospinal fluid (CSF), urine, tissue, and EDTA-whole blood specimens. The LyteStar™ TB/NTM PCR Kit 3.1 is a dual-target assay targeting the insertion sequence (IS6110) and mannose protein binding (MPB64) gene of Mycobacterium tuberculosis complex, and 16S rRNA (rrs) and RNA polymerase β subunit (rpoB) gene of NTM.

Specifications and Features

Multiplex kit for Detection and Differentiation:
Highest Analytical Sensitivity
MTBC specific; IS6110 and MPB64-genes
0.32 cp/μl
NTM specific; rrs and rpoB-genes
9.52 cp/μl
Internal Control (IC); heterologous RNA

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 and NTM, 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 private laboratory in comparison to the clinical site’s reference method.
  • In comparison to the reference test, all samples tested with 100% concordance.
  • The LyteStar™ Dengue Typing RT-PCR Kit 1.0 achieved 100% sensitivity and 100% specificity for the detection of detection of MTBC and NTM.

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 in vitro transcripts of synthesized target genes of MTBC and NTM 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/NTM PCR Kit 3.1

Cat. No.     /     Reactions
883103                   96
883101                   24

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