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    WizDx™ CrystalMix MTB/MDR

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    WizDx™ CrystalMix MTB/MDR
    Advanced Molecular Diagnostics for Drug-Resistant Tuberculosis The WizDx™ CrystalMix MTB/MDR Kit is designed for the qualitative detection of Mycobacterium tuberculosis and its resistance to Rifampicin (RIF) and Isoniazid (INH) in MTB samples.
    Catalog Package
    DX1221 48 Tests

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    • Overview
      • Simultaneous and Accurate Detection
      • - Detects Mycobacterium tuberculosis and drug-resistant strains (RIF and INH) in a single test
      • Fast Results: Delivers accurate diagnosis within 65 minutes
      • High Sensitivity: Detects as low as 150 copies per reaction
      • 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
      • - AI-driven Analysis: Automatically interprets results for quick and intuitive confirmation
      • 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 (INH), HEX (RIF), ROX (MTB), Cy5 (Internal control)
      Tests for Package 48 Tests/kit
      Reagent Type Lyophilized (Freeze-dried) in PCR tube
      Limit of Detection (LoD) 100 copies/rxn for MTB, 100 copies/rxn for , 100 copies/rxn for 
      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 mycobacterium, non-TB DNA, or susceptible strains.
      Sample Types Sputum, sputum sediment specimens.
      Shipping/Storage Shipping and storage at room temperature for 12 months
      Compatible Instruments CLEO™ Q16 (Wizbiosolutions), CFX96 (Bio-Rad)
    • Technical Data
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    • Protocol
      WizDx™ CrystalMix MTB/MDR
    • Storage & Shipping
      • Room temperature (4 - 25 ℃)