RealStar® Clostridium difficile PCR Kit 1.0/2.0 IVD
altona Diagnostics

RealStar® Clostridium difficile PCR Kit 1.0/2.0 IVD

171013/172013

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The RealStar® Clostridium difficile PCR Kit 1.0 and the RealStar® Clostridium difficile PCR Kit 2.0 are in vitro diagnostic tests, based on real-time PCR technology, for the qualitative detection and differentiation of toxin A (tcdA) and toxin B (tcdB) specific DNA of Clostridium difficile.They can be used with various real-time PCR instruments.

RealStar® Clostridium difficile PCR Kit 1.0

Key Features:

  • Detection and Differentiation of C. difficile Toxin A and Toxin B specific DNA
  • Testing within Enteric Virus and Bacteria Test Kit Panel
  • Ready to use Kit including Internal Control and Positive Control
  • CE-IVD marked in vitro Diagnostic Test

C. difficile Toxin B specific DNA detected in the FAM detection channel [A] and C. difficile Toxin A specific DNA detected in the Cy5 detection channel [B]. The Internal Control (IC) is detected in the JOE detection channel [C] and impaired in case of high positive samples. Red: C. difficile A+B+ ; Blue: C. difficileA−B+ ; Green: C. difficile A−B−; Black: NTC.

Product Information PDF

Order No. 171013
Rxns 96
Transportation Dry ice
For use with m2000rt
Mx 3005PTM QPCR System
VERSANT® kPCR Molecular System AD
ABI Prism® 7500 SDS and 7500 Fast SDS
LightCycler® 480 Instrument II
Rotor-Gene® 6000
Rotor-Gene® Q 5/6 plex Platfom

 

The following kits and systems are suitable for nucleic acid extraction:

  • QIAamp® DNA Mini Kit (QIAGEN)
  • QIAsymphony® (QIAGEN)
  • NucliSENS® easyMag® (bioMérieux)
  • MagNA Pure 96 System (Roche) • m2000sp (Abbott)
  • Maxwell® 16 IVD Instrument (Promega)
  • VERSANT® kPCR Molecular System SP (Siemens Healthcare)

Alternative nucleic acid extraction systems and kits might also be appropriate. The suitability of the nucleic acid extraction procedure for use with RealStar® Clostridium difficile PCR Kit 1.0 has to be validated by the user


RealStar® Clostridium difficile PCR Kit 2.0

Key Features:
  • Detection and Differentiation of C. difficile Toxin A and Toxin B specific DNA
  • Ready to use Kit including Internal Control and Positive Control
  • Compatible with various real-time PCR platforms
  • CE-IVD marked in vitro Diagnostic Test

Product Information PDF

Positive Control of C. difficile Toxin B (tcdB) specific DNA (blue) detected in the FAM detection channel (A). Positive Control C. difficile Toxin A specific DNA detected in the Cy5 detection channel [B] (tcdA) specific DNA (red) detected in the Cy5 detection channel (B). Internal Control (IC) is detected in the VIC detection channel (C).

Order No. 172013
Rxns 96
Transportation Dry ice
For use with Mx 3005PTM QPCR System
VERSANT® kPCR Molecular System AD
ABI Prism® 7500 SDS and 7500 Fast SDS
LightCycler® 480 Instrument II
Rotor-Gene® 6000
Rotor-Gene® Q 5/6 plex Platfom
CFX96™ Real-Time PCR Detection System and
CFX96™ Deep Well Real-Time PCR Detection System

 

The following kits and systems are suitable for nucleic acid extraction:

  • QIAamp® DNA Mini Kit (QIAGEN)
  • QIAsymphony® (QIAGEN)
  • NucliSENS® easyMag® (bioMérieux)
  • MagNA Pure 96 System (Roche)
  • m2000sp (Abbott)
  • Maxwell® 16 IVD Instrument (Promega)
  • VERSANT® kPCR Molecular System SP (Siemens Healthcare)

Alternative nucleic acid extraction systems and kits might also be appropriate. The suitability of the nucleic acid extraction procedure for use with RealStar® Clostridium difficile PCR Kit 2.0 has to be validated by the user.