• Tuberculosis >

    WizDx™ CrystalMix MTB/NTM

    Technical Data Image
    WizDx™ CrystalMix MTB/NTM
    High‑Performance Molecular Diagnostics for Tuberculosis and Non‑tuberculosis The WizDx™ CrystalMix MTB/NTM Kit is a multiplex real-time PCR assay designed for the qualitative detection of Mycobacterium tuberculosis (MTB) and non-tuberculous mycobacteria (NTM), using sputum or sputum sediment specimens.
    Catalog Package
    DX1234 96 tests
    • Overview
      • Simple procedures for diagnosis of Mycobacterium Tuberculosis (MTB) and Non-tuberculosis mycobacteria (NTM) with ready-to-use reagents that assure high specificity & sensitivity.
      • Hot-start PCR technology minimizes non-specific PCR reactions and increases specificity.
      • Uracil-DNA glycosylase (UDG) technology prevents carryover contamination.
      • Ready-to-use freeze-dried PCR mix allows convenient storage and a minimal test procedure.
      • Internal cellular control helps prevent false negatives.
      • Using CLEO™ Q16, the PCR setup can be easily configured with QR code recognition, and test results can be automatically analyzed using AI, allowing for quick and intuitive confirmation of results.
      • MFDS approval.
      • Automated Analysis: Generates result reports instantly
      • Raw Data Verification: Enables confirmation of raw data analysis
      • Rapid Result Screening: Quick identification of positive and negative results
      • LIS Compatibility: Seamless integration with Laboratory Information Systems
      • Flexible Output Options
      • - Print-ready result reports
      • - Export and download in Excel format
    • Specifications
      Principle of Procedure Multiplex Real-time PCR
      Target FAM for Mycobacterium tuberculosis (MTB), HEX for Non-tuberculosis mycobacteria (NTM), and Cy5 for the internal control
      Tests for Package 96 Tests/kit
      Reagent Type Lyophilized (Freeze-dried) in a PCR tube
      Limit of Detection (LoD) 10 copies/rxn for Mycobacterium tuberculosis (MTB), 25 copies/rxn for non-tuberculosis mycobacteria (NTM)
      Precision Respectively detect the reference specimen of high and low concentrations in different time ranges, 10 times, and the precision values of intra-assay and inter-assay Ct values were all <5%..
      Specificity No cross-reactivity of the assay was observed for Adenovirus, hCoV, Parainfluenza, RSV, SARS-CoV-2, Influenza virus, Legionella pneumophila, Mycoplasma pneumoniae, Streptococcus pneumoniae, Enterococcus faecalis, Enterococcus faecium, HPV, and HIV.
      Sample Types Sputum, sputum sediment specimens.
      Shipping/Storage Shipping and storage at room temperature for 12 months
    • Protocol
      WizDx™ CrystalMix MTB/NTM
    • Storage & Shipping
      • Room temperature (4 - 25 ℃)