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CLEO ONE
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  • Tuberculosis

    WizDx™ CrystalMix MTB/MDR

    Real-Time PCR Kit for M. tuberculosis and Multidrug-Resistance Detection

    The WizDx™ CrystalMix MTB/MDR PCR Kit is a lyophilized, ready-to-use real-time PCR assay for the simultaneous detection of Mycobacterium tuberculosis (MTB) and key multidrug-resistance (MDR) markers in clinical respiratory specimens. The CrystalMix format simplifies workflow and delivers high sensitivity and specificity for rapid molecular diagnosis.

    ●  MFDS

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    • Key Features
      • Simultaneously detects Mycobacterium tuberculosis and drug-resistant strains (RIF and INH) in a single test.
      • Fast Results: diagnosis within 65 minutes.
      • High sensitivity and specificity.
      • Accurate Mutation Identification: Enables precise single-gene mutation detection.
      • Enhanced PCR Technologies.
        - Uracil-DNA Glycosylase (UDG): Prevents carryover contamination.
        - Hot-start PCR: Minimizes non-specific reactions and enhances specificity.
        - Freeze-dried PCR Mix: Ready-to-use, room-temperature stable formulation requiring no cold chain.
      • Built-in Internal Control: Prevents false negatives and ensures reliable results.
      • Seamless Operation with CLEO™ Q16.
        - QR Code Setup: Enables faster and simpler test preparation.
        - Automatically interprets results for quick and intuitive confirmation.
    • Specifications
      Principle of Test
      Multiplex Real-time PCR
      Target
      FAM (INH), HEX (RIF), ROX (MTB), Cy5 (Internal control)
      Reagent Type
      Lyophilized (Freeze-dried) in PCR tube
      Limit of Detection (LoD)
      100 copies/rxn for MTB, 100 copies/rxn for rpoB, 100 copies/rxn for inhA
      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 with other mycobacteria, non-TB DNA, or susceptible strains
      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 ℃)
    • How to use
    • Ordering information

      Product Name

      Cat No.

      Package
      WizDx™ CrystalMix MTB/MDR DX1221 96 Tests