Treponema pallidum + Herpes simplex (HSV1 + HSV2) + Chlamydia trachomatis serovar L PCR Kit CE/IVD

Treponema pallidum + Herpes simplex (HSV1 + HSV2) + Chlamydia trachomatis serovar L PCR Kit CE/IVD

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RealCycler ULCGEN-
Catalog Number: RealCycler ULCGEN-

1 Intended use:
RealCycler ULCGEN-U / ULCGEN-G is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Treponema pallidum, Herpes Simplex virus (type 1 + type 2) and Chlamydia trachomatis L serovar (causal agent of lymphogranuloma venereum) DNA 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 the corresponding channel of FAM fluorophore, the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore, Herpes Simplex virus (type 1 + type 2) is detected in the corresponding channel of TxR fluorophore and Chlamydia trachomatis L serovar is detected in the corresponding channel of Alx647 or Cy5 fluorophore.

3 Technical specifications
Sensitivity:
- Treponema pallidum: 100 copies/μL.
-Herpes Simplex virus type 1: 10 copies/μL.
-Herpes Simplex virus type 2: 10 copies/μL.
-Chlamydia trachomatis L serovar: 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:
- Treponema pallidum: PolA gene.
- Herpes Simplex virus type 1: US6 gene.
- Herpes Simplex virus type 2: DNA polymerase gene.
- Chlamydia trachomatis L serovar: pmpH gene.

Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).

4. Contents
RealCycler ULCGEN-U includes the AmpliMix and an ULCGEN DNA Positive Control, which contains a mixture of Treponema pallidum, Herpes Simplex virus (type 1 + type 2) and Chlamydia trachomatis L serovar DNA.
All reagents are ready to use without adding or rebuilding any component.
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