Mycoplasma genitalium + Trichomonas vaginalis + Chlamydia trachomatis serovar L PCR Kit CE/IVD
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SKU
RealCycler MGTVCL-
Catalog Number: RealCycler MGTVCL-
1 Intended use:
RealCycler MGTVCL is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Mycoplasma genitalium, Trichomonasvaginalis 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 Mycoplasma genitalium is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore, Trichomonas vaginalis is detected in the corresponding channel of TxR fluorophore and Chlamydia trachomatisL serovar is detected in the corresponding channel of Alx647 fluorophore.
3 Technical specifications
Sensitivity
- Mycoplasmagenitalium: 10 copies/μL.
- Trichomonas vaginalis: 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:
Mycoplasma genitalium: adhesin gene (mgpB).
Trichomonas vaginalis: 2-kb repeated sequence.
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 MGTVCL includes the AmpliMix dispensed into amplification tubes and a MGTVCL DNA Positive Control, which contains a mixture of Mycoplasmagenitalium, Trichomonas vaginalis and C. trachomatisL serovar DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler MGTVCL is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Mycoplasma genitalium, Trichomonasvaginalis 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 Mycoplasma genitalium is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore, Trichomonas vaginalis is detected in the corresponding channel of TxR fluorophore and Chlamydia trachomatisL serovar is detected in the corresponding channel of Alx647 fluorophore.
3 Technical specifications
Sensitivity
- Mycoplasmagenitalium: 10 copies/μL.
- Trichomonas vaginalis: 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:
Mycoplasma genitalium: adhesin gene (mgpB).
Trichomonas vaginalis: 2-kb repeated sequence.
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 MGTVCL includes the AmpliMix dispensed into amplification tubes and a MGTVCL DNA Positive Control, which contains a mixture of Mycoplasmagenitalium, Trichomonas vaginalis and C. trachomatisL serovar DNA.
All reagents are ready to use without adding or rebuilding any component.
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