Applied Biosystems™ TaqPath™ Menu GeneProof™ Cytomegalovirus (CMV) PCR Kit

The TaqPath Menu I GeneProof Cytomegalovirus (CMV) PCR Kit is used for the qualitative and quantitative detection of cytomegalovirus through real-time PCR technology. The kit is validated for use with DNA extracted from CSF, plasma, serum, urine, and whole blood (EDTA) specimens.

Features of the TaqPath Menu I GeneProof Cytomegalovirus (CMV) PCR Kit include:

• Compatible with other PCR kits in one workflow

• Easy to use—single master mix tube containing all components required for PCR amplification

• Minimizes contamination—the master mix contains uracil-DNA glycosylase (UNG) and dUTPs, reducing carryover contamination

• Compatible with a wide range of real-time PCR devices

The kit is approved for use on Applied Biosystems 7300/7500 and QuantStudio 3 real-time PCR systems.

Control Template

• PCR inhibition and DNA extraction efficiency control provided by an Internal Control

PCR Method

• Suitable for qPCR and RT-PCR methods

Technique

• Qualitative and Quantitative Analysis

For Use With (Equipment)

• Compatible with a wide range of real-time PCR systems, including:
  • QuantStudio™ 3/5 Real-Time PCR System
  • Applied Biosystems 7300/7500 Real-Time PCR System
  • StepOne™/StepOne Plus™ Real-Time PCR System
  • croBEE Real-Time PCR System
  • AMPLilab Real-Time PCR System
  • AriaMx Real-Time PCR System
  • BioQuant-96 Real-Time PCR System
  • CFX Connect™/CFX96™/Dx Real-Time PCR Detection System
  • CFX Opus 96 Real-Time PCR System
  • Gentier 96E/96R Real-Time PCR System
  • LightCycler™ 480
  • LineGene 9600/9600 Plus
  • Mic qPCR Cycler
  • Montania 4896 Real-Time PCR Thermocycler
  • Rotor-Gene 3000/6000/Q
  • SLAN™ Real-Time PCR System

Label or Dye

• Compatible dyes include FAM, HEX, JOE, VIC

Product Line

• TaqPath™

Quantity

• 1 kit containing reagents for 100 reactions

Sensitivity

• Analytical: Refer to Instructions for Use (IFU)
• Diagnostic: 98.32% (Confidence Interval [CI] 95%: 95.90–99.38%)

Target

• Cytomegalovirus (CMV; Human beta herpesvirus 5), specifically the gene encoding the IE1 protein

Target Specificity

• Analytical Specificity: 100% (specific to Human Cytomegalovirus)
• Diagnostic Specificity: 94.21% (CI 95%: 88.01–97.44%)

Compatibility

• Compatible with CMV NIBSC 09/162 (1st WHO International Standard for Human Cytomegalovirus in Nucleic Acid Amplification Techniques)

Sample Type

• DNA extracted from CSF, plasma, serum, urine, whole blood (EDTA)

Certification Compliance

• Compliant with CE2797 IVD/Regulation (EU) 2017/746

Unit Size

• 100 reactions

Contents and Storage

• Kit Contents:
  • Mastermix
  • Calibrators
  • Internal Control
• Storage Conditions: Store at –20 ± 5°C