Borrelia burgdorferi PCR Kit CE/IVD

1 Intended Use:
RealCycler BBUR is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Borrelia burgdorferi DNA in clinical samples.
The system includes an internal control CHIC (Competitive Heterologous Internal Control) to prevent false negatives due to reaction inhibition.

2 Principle of the test
The polymerase chain reaction (PCR) is based on the amplification of a specific region of the DNA/RNA by using complementary primers to the target sequence. Real-time PCR uses marked probes with fluorophores that emit fluorescence in the case of amplification. The cycle of the PCR protocol in which appears significant fluorescence is proportional to the DNA/RNA quantity present in the sample. This value is called Cycle Threshold (Ct) or Cycle Quantification (Cq).
The amplification of Borrelia burgdorferi is detected in the corresponding channel of FAM fluorophore and CHIC is detected in the corresponding channel of Alx532 fluorophore

3 Technical specifications:
Sensitivity: Borrelia burgdorferi: 100 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.

Specificity
Borrelia burgdorferi: ospA gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
These technical specifications have been verified using QCMD Borreliaburg dorferi 2011 panel.

Kit contents:
RealCycler BBUR includes the AmpliMix dispensed and a B. burgdorferi DNA Positive Control.

Associated diseases Borreliosis (or Lyme disease), relapsing fever.

Sample material: Purified DNA from clinical samples.