Haemophilus ducreyi and Treponema pallidum PCR Kit CE/IVD

1 Intended use:
RealCycler TPHD is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Treponema pallidum and Haemophilus ducreyi 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).
The amplification of Treponema pallidum is detected in FAM, Haemophilus ducreyi in TxR and the internal control in Alx532.2

3 Technical specifications
Sensitivity: 100 copies/μL for Treponema pallidum and 1 copy/μL for Haemophilus ducreyi.
Specificity: Treponema pallidum (PolA gene) and Haemophilus ducreyi (hgbA gene).

4 Contents
RealCycler TPHD includes the AmpliMix and a TPHD DNA Positive Control, which contains a mixture of Treponema pallidum and Haemophilus ducreyi DNA.
All reagents are ready to use without adding or rebuilding any component.