자산 1
CLEO ONE
ENG KOR
  • Tuberculosis

    WizDx™ CrystalMix MTB/NTM

    Real-Time PCR Kit for Mycobacterium tuberculosis and NTM Detection


    The WizDx™ CrystalMix MTB/NTM PCR Kit is a lyophilized, ready-to-use real-time PCR assay for the simultaneous detection of Mycobacterium tuberculosis (MTB) and non-tuberculous mycobacteria (NTM) in clinical respiratory specimens. The CrystalMix format simplifies workflow and provides high sensitivity and specificity for accurate molecular diagnosis.

    ●  MFDS Approved (Korea)

    • Key Features
      • Simultaneous detection of MTB and NTM in a single PCR reaction
      • Lyophilized ready-to-use mix with minimal preparation
      • High sensitivity and specificity
      • Internal control included for assay validation
      • Hot-start PCR technology minimizes non-specific PCR reactions and increases specificity.
      • Uracil-DNA glycosylase (UDG) technology prevents carryover contamination.
      • Using CLEO™ Q16, the PCR setup can be easily configured with QR code recognition, and test results can be automatically analyzed, allowing for quick and intuitive confirmation of results.
    • Specifications
      Principle of Test
      Multiplex Real-time PCR
      Target
      FAM for Mycobacterium tuberculosis (MTB), HEX for Non-tuberculosis mycobacteria (NTM), and Cy5 for the internal control
      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
      • 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
    • Storage & Shipping
      Room temperature (4 - 25 ℃)
    • Ordering information

      Product Name

      Cat No.

      Package

      WizDx™ CrystalMix MTB/NTM DX1234 96 Tests