Plasmid ampC DNA (ACC + EBC) and (CIT + DHA) PCR Kit CE/IVD

1 Intended use:
RealCycler AMPC is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from plasmid mediated ampC genes: ACC, EBC, CIT and DHA 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 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).
In the AMPC1 amplification, ACC is detected in the corresponding channel of FAM fluorophore, EBC is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore. In the AMPC2 amplification, CIT is detected in the corresponding channel of FAM fluorophore, DHA is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.

3 Technical specifications
Sensitivity
- blaACC: 100 copies/μL,
- blaEBC: 500 copies/μL,
- blaCIT: 10 copies/μL and
- blaDHLA: 1 copy/μL .
Specificity
- ACC (ACC gene),
- EBC (ACT gene),
- CIT (CMY gene) and DHA (DHA gene).

4 Contents
RealCycler AMPC includes the AMPC1 AmpliMix, AMPC2 AmpliMix, an ACC DNA Positive Control, an EBC DNA Positive Control, a CIT DNA Positive Control and a DHA DNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.