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artus Borrelia LC PCR Kit CE

For quantitative detection of Borrelia DNA using real-time PCR
  • Compliance with EU IVD Directive 98/79/EC
  • Highly sensitive detection of as few as 2.8 copies/µl (LightCycler 2.0)
  • Specific detection of all members of Borrelia burgdorferi sensu lato
  • High reliability using the internal control
  • Accurate quantitation over a very broad range

The artus Borrelia 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 and quantitation of DNA of all members of Borrelia burgdorferi sensu lato including Borrelia species that are pathogenic for humans (B. burgdorferi sensu stricto, B. garinii, and B. afzelii). The kit is intended for in vitro diagnostic use. 

Cat No./ID: 4551063
artus Borrelia LC PCR Kit (24) CE
For 24 reactions on the LightCycler 1.1/1.2/1.5/2.0 Instruments: Master, 4 Quantitation Standards, Internal Control, Water (PCR grade)
Cat No./ID: 4551065
artus Borrelia LC PCR Kit (96) CE
For 96 reactions on the LightCycler 1.1/1.2/1.5/2.0 Instruments: Master, 4 Quantitation Standards, Internal Control, Water (PCR grade)

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


0
Reliable quantitation of Borrelia load.
Detection of the quantitation standards (Borrelia LC QS 1–4) on the LightCycler 2.0 instrument using the artus Borrelia LC PCR Kit. NTC: no template control.
1
CE-IVD-marked.
2
In vitro diagnostic medical device.
Performance

To ensure highest sensitivity, the artus Borrelia LC PCR Kit has been optimized to detect low copy numbers of Borrelia DNA. The analytical sensitivity of the kit is 3.3 copies/μl in the PCR on the LightCycler 1.1/1.2/1.5 Instrument and 2.8 copies/μl in the PCR on the LightCycler 2.0 Instrument.

For highest specificity, validation of the artus Borrelia LC PCR Kit was carried out using various Borrelia species, including B. burgdorferi, B. garinii, B. afzelii, B. valaisiana, B. hermsii, and related pathogens. 

Performance characteristics of artus Borrelia LC PCR Kit
Kitartus Borrelia LC PCR Kit
Sample types* Skin biopsies, synovial fluid, cerebral spinal fluid (CSF), blood, ticks, or culture
Analytical sensitivity 2.8 copies/µl in the PCR (LightCycler 2.0); 3.3 copies/µl in the PCR (LightCycler 1.1/1.2/1.5)
 Specificity  All members of Borrelia burgdorferi sensu lato, including B. burgdorferi sensu stricto, B. garinii, B. afzelii, B. valaisiana, and B. hermsii)
* The artus Borrelia LC PCR Kit has been tested with all sample types listed and is validated for use with cerebral spinal fluid.

Principle

The artus Borrelia LC PCR Kit is based on the amplification and simultaneous detection of a specific region of the Borrelia genome using real-time PCR. The kit provides high levels of specificity, sensitivity, and reproducibility.

Each artus Borrelia LC PCR Kit provides 4 Borrelia quantitation standards (see figure "Reliable quantitation of Borrelia load"). Use of the standards enables accurate quantitation of pathogen load. In addition, the kit contains 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 Borrelia PCR is not reduced.

Specifications of artus Borrelia LC PCR Kit
Kitartus Borrelia LC PCR Kit
Sample types* Skin biopsies, synovial fluid, cerebral spinal fluid (CSF), blood, ticks, or culture
Amplicon 102 bp region of the Borrelia genome
* The artus Borrelia LC PCR Kit has been tested with all sample types listed and is validated for use with cerebral spinal fluid.

Procedure

The artus Borrelia LC PCR Kit provides all necessary reagents optimized for reliable Borrelia DNA detection and quantitation. Simply add template DNA to the ready-to-use PCR master mix, 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.

Applications

The artus Borrelia LC PCR Kit enables rapid and sensitive detection of Borrelia DNA with highly accurate quantification. The kit has been tested for use with DNA purified from skin biopsies, synovial fluid, CSF, blood, ticks, and culture using the QIAamp DNA Mini Kit and is validated for use with DNA purified from CSF using the QIAamp DNA Mini Kit. 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 Skin biopsies, synovial fluid, cerebrospinal fluid (CSF), blood, ticks and culture
Thermal cycler LightCycler 1.1/1.2/1.5 instruments
What detected DNA of all members of Borrelia burgdorferi sensu lato
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