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artus Mycobac. diff. LC PCR Kit CE

For quantitative detection of mycobacterial DNA and differentiation of species and subspecies

  • Compliance with EU IVD Directive 98/79/EC
  • High reliability using the internal control
  • Sensitive detection of as few as 1.5 copies/µl (LightCycler 1.1/1.2/1.5)
  • Accurate quantitation using the 4 standards supplied
The artus Mycobac. diff. LC PCR Kit is a ready-to-use molecular detection kit for real-time PCR. The kit provides all necessary reagents optimized for reliable detection of DNA of members of the M. tuberculosis complex and the M. avium complex and differentiation between M. tuberculosis complex, M. avium subspecies, and M. intracellulare for in vitro diagnostic use.
Cat No./ID: 4556063
artus Mycobac. diff. LC PCR Kit (24) CE
For 24 reactions on the LightCycler 1.1/1.2/1.5/2.0 Instruments: Master, Mg Solution, 4 Quantitation Standards (M. tuberculosis), Positive Control (M. avium), Positive Control (M. intracellulare), Internal Control, Water (PCR grade)
Cat No./ID: 4556065
artus Mycobac. diff. LC PCR Kit (96) CE
For 96 reactions on the LightCycler 1.1/1.2/1.5/2.0 Instruments: Master, Mg Solution, 4 Quantitation Standards (M. tuberculosis), Positive Control (M. avium), Positive Control (M. intracellulare), Internal Control, Water (PCR grade)

The artus Mycobac. diff. LC PCR Kit CE is intended for in vitro diagnostic use in Europe.


0
Reliable quantitation of M. tuberculosis load and detection of M. avium and M. intracellulare.
Detection of the quantitation standards (M. tuberculosis LC QS 1–4) and positive controls. NTC: no template control.
1
Reliable differentiation between M. tuberculosis complex, M. avium subspecies, and M. intracellulare.
Differentiation between mycobacterial subspecies on the LightCycler instrument by melting curve analysis using the artus Mycobac. diff. LC PCR Kit.
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M. tuberculosis.
3
CE-IVD-marked.
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In vitro diagnostic medical device.
Performance

To ensure highest sensitivity, the artus Mycobac. diff. LC PCR Kit has been optimized to detect low copy numbers of mycobacterial DNA. The analytical sensitivity of the kit is 1.5 copies/µl in the PCR for the M. tuberculosis complex on LightCycler 1.1/1.2/1.5 Instruments.

Performance characteristics of artus Mycobac. diff. LC PCR Kit
Kitartus Mycobac. diff. LC PCR Kit
Validated sample types Sputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebral spinal fluid (CSF), stomach fluid, or peritoneal punction
Analytical sensitivity 1.5 copies/µl in the PCR for M. tuberculosis complex
3.8 copies/µl in the PCR for M. avium subspecies
2.8 copies/µl in the PCR for M. intracellulare
 Specificity  All members of the M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, M. pinnipedii) and the M. avium complex (M. avium subsp. avium, M. avium subsp. paratuberculosis, M. avium subsp silvaticum, M. avium subsp. hominissuis, M. intracellulare)

Principle

The artus Mycobac. diff. LC PCR Kit is based on the amplification and simultaneous detection of a specific region of the mycobacterial genome using real-time PCR. The kit enables quantitative detection of DNA of members of the M. tuberculosis complex and detection of the M. avium complex using real-time PCR, and differentiation between M. tuberculosis complex, M. avium subspecies, and M. intracellulare by melting curve analysis (see figure "Reliable differentiation between M. tuberculosis complex, M. avium subspecies, and M. intracellulare"). The kit provides high levels of specificity, sensitivity, and reproducibility.

Each artus Mycobac. diff. LC PCR Kit provides 4 M. tuberculosis quantitation standards and positive controls for M. avium and M. intracellulare (see figure "Reliable quantitation of M. tuberculosis load and detection of M. avium and M. intracellulare"). 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 PCR is not reduced.

Specifications of artus Mycobac. diff. LC PCR Kit
Kitartus Mycobac. diff. LC PCR Kit
Validated sample types Sputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebral spinal fluid (CSF), stomach fluid, or peritoneal punction
Amplicon 163 bp region of the mycobacterial genome

Procedure

The artus Mycobac. diff. LC PCR Kit provides all necessary reagents optimized for reliable detection and quantitation of DNA from all members of the M. tuberculosis complex and the M. avium complex. 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 purification of mycobacterial DNA, the QIAamp DNA Mini Kit is to be used.

Applications
The artus Mycobac. diff. LC PCR Kit enables rapid and sensitive detection of DNA of members of the M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. microti, M. pinnipedii) and members of the M. avium complex (M. avium subsp. avium, M. avium subsp. paratuberculosis, M. avium subsp silvaticum, M. avium subsp. hominissuis, M. intracellulare) from sputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebrospinal fluid (CSF), stomach fluid, and peritoneal punction. The kit enables quantitative detection of DNA of members of the M. tuberculosis complex, and discrimination between the M. tuberculosis complex, different M. avium subspecies, and M. intracellulare by melting curve analysis. The kit is available for use on the LightCycler 1.1/1.2/1.5/2.0 Instruments.
Features
Specifications
Quantitative/qualitative Quantitative
Recommended sample prep QIAamp DNA Mini Kit
RUO/CE/ASR CE
Sample type Sputum, bronchoalveolar lavage (BAL), bronchial secretion, cerebrospinal fluid (CSF), stomach fluid, peritoneal punction
Thermal cycler LightCycler
What detected Mycobacterium tuberculosis complex and M. avium complex
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