Carbapenemase KPC gene + NDM-1 (New Delhi Metalobetalactamase) gene PCR Kit CE/IVD

1 Intended use:
RealCycler KPND is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from blaKPC genes and blaNDM-1 gene (New Delhi metallo-beta-lactamase) simultaneously 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 fluorophoresthat 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 KPC is detected in FAM, NDM-1 in TxR and the internal control in Alx532.

3 Technical specifications
Sensitivity
- blaKPC: 100 copies/μL and
- blaNDM-1: 1000 copies/μL.
Specificity:
- KPC (blaKPC genes) and New Delhi metallo-beta-lactamase (blaNDM-1 gene).

4 Contents
RealCycler KPND includes the KPND AmpliMix and an KPND DNA Positive Control, which contains a mixture of KPC and NDM-1 DNA.
All reagents are ready to use without adding or rebuilding any component.