CoxA16/EV71/EV-U Real-Time PCR Kit

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For Research Use Only (RUO)

Introduction

The CoxA16/EV71/EV-U Real-Time PCR Kit is an in vitro diagnostic (IVD) reagent, based on fluorescent PCR technology, intended for the detection of Coxsackievirus A16 (CoxA16), Enterovirus 71 (EV71), and universal enterovirus (EV-U) nucleic acids in throat swab samples from infants and children. The test allows for the simultaneous differentiation of CoxA16 and EV71, the primary agents associated with Hand, Foot, and Mouth Disease (HFMD).

Features

  • Superior Performance: Better performance for more accurate results

  • Child-friendly: Child-friendly testing using throat swab samples

  • 3-in-1 Multiplex RT-PCR: Detects the main HFMD viruses in a single reaction

  • Smart: Automatic interpretation of results on the STC Real-Time PCR system

Parameters

Target CoxA16, EV71, EV-U
Clinical Performance
  • Clinical Sensitivity:

    • 96,43% (CA16)

    • 100% (EV71)

    • 98,33% (EV-U)

  • Clinical Specificity:

    • 100% (CA16)

    • 100% (EV71)

    • 100% (EV-U)

Limit of Detection (LOD) 2,0 × 10⁻² CCID₅₀/0,1 mL
Assay Time 115 min
Storage Temperature -20±5℃
Sample Type

Throat swab

CE

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