artus M. tuberculosis PCR Kits CE

For quantitative detection of DNA of all members of the M. tuberculosis complex using real-time PCR

Products

artus M. tuberculosis PCR Kits CE are intended for in vitro diagnostic use in Europe.

Features

  • Compliance with EU IVD Directive 98/79/EC
  • High reliability using the internal control
  • Highly sensitive detection of as few as 0.23 copies/µl (RG kit)
  • Accurate quantitation using the 4 standards supplied

Product Details

artus M. tuberculosis PCR Kits are ready-to-use molecular detection kits for real-time PCR. The kits provide all necessary reagents optimized for reliable detection and quantitation of DNA from all members of the M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, and M. pinnipedii) for in vitro diagnostic use.

Performance

To ensure highest sensitivity, artus M. tuberculosis PCR Kits have been optimized to detect low numbers of mycobacterial DNA. The analytical sensitivity of the artus M. tuberculosis RG PCR Kit is 0.23 copies/µl in the PCR on the Rotor-Gene Q/6000 instrument.

Performance characteristics of artus M. tuberculosis RG PCR Kit
Kitartus M. tuberculosis RG PCR Kit
Validated sample types Human sputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebral spinal fluid (CSF), stomach fluid, or peritoneal punction
Analytical sensitivity 0.23 copies/µl in the PCR
 Specificity  All members of the M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, and M. pinnipedii)

Principle

artus M. tuberculosis PCR Kits are based on the amplification and simultaneous detection of a specific region of the mycobacterial genome using real-time PCR. The kits provide high levels of specificity, sensitivity, and reproducibility.

Each artus M. tuberculosis PCR Kit provides 4 M. tuberculosis quantitation standards (see figure " Reliable quantitation of M. tuberculosis complex pathogen load"). Use of the standards enables accurate quantitation of pathogen load. In addition, the kits contain a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical M. tuberculosis PCR is not reduced.

Specifications of artus M. tuberculosis RG PCR Kit
Kitartus M. tuberculosis RG PCR Kit
Validated sample types Human sputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebral spinal fluid (CSF), stomach fluid, or peritoneal punction
Amplicon 159 bp region of the mycobacterial genome
See figures

Procedure

artus M. tuberculosis PCR Kits provide all necessary reagents optimized for reliable detection and quantitation of DNA of all members of the M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, and M. pinnipedii). Simply add template DNA to the ready-to-use PCR master mix and Mg solution, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

For DNA purification, the QIAamp DNA Mini Kit is to be used to ensure legally validated performance.

Applications

artus M. tuberculosis PCR Kits enable rapid and sensitive detection of DNA of all members of the M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, and M. pinnipedii) from sputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebrospinal fluid (CSF), stomach fluid, and peritoneal punction with accurate quantification. Kits are available for use on the ABI PRISM 7000, 7700, and 7900HT SDS, on the LightCycler 1.1/1.2/1.5/2.0 Instruments, or on Rotor-Gene Q instruments.

Supporting data and figures

Specifications

FeaturesSpecifications
Quantitative/qualitativeQuantitative
What detectedMycobacterium tuberculosis DNA (M. tuberculosis, M. africanum, M. bovis...)
Recommended sample prepQIAamp DNA Mini Kit
Thermal cyclerABI PRISM 7000, 7700, 7900HT SDS, LightCycler, Rotor-Gene 3000
RUO/CE/ASRCE-IVD
Sample typeSputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebrospinal fluid (CSF), stomach fluid, peritoneal punction

Resources

Safety Data Sheets (1)
Certificates of Analysis (1)