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Measles and Rubella Viruses Real-Time PCR Kit

IVDR

Introduction

The Measles and Rubella Viruses Real-Time PCR Kit is an in vitro diagnostic assay for the qualitative detection and differentiation of measles virus and rubella virus nucleic acids in throat swab specimens. It combines the functions of a measles test kit and a rubella test kit in a single real-time PCR assay. The multiplex PCR assay is intended for patients with signs and symptoms of respiratory infection, or skin symptoms considered together with clinical and epidemiological risk factors.

 

By detecting the measles virus N gene and the rubella virus E1 gene in one test, the kit supports laboratory differentiation of two infections that may require similar initial diagnostic workups. RNase P is included as an internal control to monitor the testing process.

Features

  • Two targets in one multiplex PCR test: Detects and differentiates measles virus and rubella virus nucleic acids in a single assay.
  • Whole-process control: RNase P is included as an internal control to support reliable result interpretation.
  • Defined specimen type: Designed for throat swab specimens collected from the intended patient population.
  • Efficient laboratory workflow: Supports 96 tests in 109 minutes and is suitable for compatible mainstream real-time PCR instruments.

Parameters

Target

N gene of Measles virus, E1 gene of Rubella Virus and RNaseP as IC

Clinical Sensitivity

100% (Measles) and 100% (Rubella)

Clinical Specificity

99.5% (Measles) and 99.6% (Rubella)

Limit of detection

10 TCID50/mL (Measles) and 20 TCID50/mL (Rubella)

Sample input volume

5μL

Sample type

Throat swabs

 

Catalog

Product

Package

MD112302C00201-50T

Measles and Rubella Viruses Real-time PCR Kit

50 Tests/Kit

Applications

This measles and rubella real-time PCR kit is designed for professional infectious disease testing using throat swab specimens. Appropriate applications include:

Differential testing for measles and rubella: Qualitative detection and differentiation of measles virus and rubella virus nucleic acids when the two infections are considered in the diagnostic workup.

Testing of clinically relevant throat swabs: Laboratory analysis of throat swabs from patients with measles signs and symptoms, or skin symptoms evaluated with clinical and epidemiological risk factors.

Routine molecular laboratory workflows: Multiplex testing in laboratories that require an internal control and compatibility with established real-time PCR instruments.

Certificate

CE-IVDR

 

 

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