RealAccurate™ Mycobacterium tuberculosis PCR kit

Summary: 

The RealAccurate Mycobacterium tuberculosis PCR kit is a Real Time PCR test enabling detection of small amounts of Mycobacterium tuberculosis complex DNA by targeting the multicopy target IS6110 insertion element. Additionally, the kit includes a competitive amplification control of a modified Mycobacterium smegmatis strain.

Amplification and detection can be performed on Real Time PCR instruments able to detect fluorescence in the FAM- and in the  VIC/YY (Yakima Yellow)-channels.

  • Validated on > 14.000 clinical samples
  • Contains a competitive internal amplification control
  • Diagnosis within 2 hours
  • Validated on QCMD panels
  • CE labelled
Overview: 

A rapid diagnosis of Mycobacterium tuberculosis infection is particularly important since traditional culturing requires about two to four weeks. The RealAccurate Mycobacterium tuberculosis PCR kit is a Real Time PCR test enabling detection of small amounts of Mycobacterium tuberculosis complex (M. tuberculosis, bovis, microti, africanum and canetti) DNA by targeting the multicopy target IS6110 insertion element. Additionally, the kit includes a competitive amplification control of a modified Mycobacterium smegmatis strain.

Procedure: 

The RealAccurateTM Mycobacterium tuberculosis PCR Kit is a ready to use set of optimized reagents containing primers and a FAM-labeled probe for the detection of members of the Mycobacterium tuberculosis complex as well as a VIC/YY-labeled probe to detect a modified IS6110 element in the Mycobacterium smegmatis internal control DNA. Enzymes are not provided.

Clinical specimens: 
  • Sputa
  • bronchoalveolar lavage (BAL)
Internal control: 

An internal control consisting of Mycobacterium smegmatis DNA containing a modified IS6110 fragment is present in the M. tuberculosis reagent. This internal control is included in the reagent to check for PCR inhibition.

Detection: 

Amplification and detection can be performed on Real Time PCR instruments able to detect fluorescence in the FAM- and in the  VIC/YY (Yakima Yellow)-channels.

Results image: 
QCMD validation: 

Quality Control for Molecular Diagnostics (QCMD) is an international External Quality Assessment (EQA) provider for molecular diagnosis of infectious agents. PathoFinder has successfully participated in many EQA programs for respiratory pathogens in 2007 and 2008. Details of these tests are available on request. We will keep participating in QCMD programs to ensure the quality, sensitivity and specificity our products.

Benefits: 
  • Validated on > 14.000 clinical samples
  • Contains a competitive internal amplification control
  • Diagnosis within 2 hours
  • Validated on QCMD panels
  • CE labelled

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