자산 1
CLEO ONE
ENG KOR
  • Respiratory Infections

    WizDx™ COVID-19 CrystalMix™ Multi PCR Kit

    Ready-to-Use Multiplex PCR Kit for SARS-CoV-2


    WizDx™ COVID-19 CrystalMix™ Multi PCR Kit is a lyophilized, ready-to-use real-time PCR assay for the detection of SARS-CoV-2 in a single reaction. The freeze-dried CrystalMix format simplifies testing, reduces preparation steps, and delivers reliable performance for routine diagnostic use.

      MFDS Approved (Korea)

    • Key Features
      • Dual-target detection: SARS-CoV-2 RdRP and E genes
      • Lyophilized ready-to-use mix with minimal setup
      • High sensitivity and specificity
      • Hot-start PCR technology minimizes non-specific PCR reactions and increases specificity.
      • Internal control included for result validation
      • Compatible with major real-time PCR systems
      • Using CLEO Q16, the PCR setup can be easily set up with QR code recognition, and test results can be automatically analyzed, allowing for quick and intuitive confirmation of results.
    • Specifications
      Principle of Procedure Real-time PCR
      Target FAM (COVID-19 RdRp), HEX (COVID-19 N), Cy5 (Internal control)
      Reagent Type Lyophilized (Freeze-dried) in a PCR tube
      Limit of Detection (LoD) COVID-19 RdRP gene (0.72 copies/μL), COVID-19 E gene (0.77 copies/μL).
      Precision Clinical Sensitivity: 99.38% (95% CI: 96.55 – 99.89%)
      Clinical Specificity: 99.23% (95% CI: 97.24 – 99.79%)
      Overall Agreement: 99.29% (95% CI: 97.92 – 99.76%)
      Specificity Analytical specificity was evaluated for cross-reactivity by testing similar intestinal bacteria and microorganisms. The test was repeated three times and showed no cross-reactivity.
      Sample Types Sputum, Bronchial or Tracheal lavage
      Shipping/Storage Shipping and Storage at room temperature for 12 months
      Compatible Instruments CLEO™ Q16 (Wizbiosolutions), CFX96 (Bio-Rad)
    • Protocol
    • Storage & Shipping
      • Room temperature (4 - 25℃)
    • Ordering information

      Product Name

      Cat No.

      Package

      WizDx™ COVID-19 CrystalMix™ Multi PCR Kit DX1203A 96 Tests