Mycoplasma genitalium + Trichomonas vaginalis + Ureaplasma urealyticum and Ureaplasma parvum PCR Kit CE/IVD
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SKU
RealCycler MGTVUS-
Catalog Number: RealCycler MGTVUS-
1 Intended use:
RealCycler MGTVUS is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Mycoplasma genitalium, Trichomonas vaginalis, Ureaplasma urealyticum and Ureaplasma parvum DNA simultaneously in clinical samples.
Ureaplasma urealyticumpathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler UREQ).
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 vaginalisis detected in the corresponding channel of TxR fluorophore and Ureaplasma urealyticum andUreaplasma parvumis detected in the corresponding channel of Alx647 fluorophore.
3 Technical specifications
Sensitivity
- Mycoplasma genitalium: 100 copies/μL.
- Trichomonas vaginalis: 10 copies/μL.
- Ureaplasma urealyticum: 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.
Ureaplasma urealyticum: urease gene.
Ureaplasma parvum: urease gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler MGTVUS includes the AmpliMix dispensed into amplification tubes and a MGTVUS DNA Positive Control, which contains a mixture of Mycoplasma genitalium, Trichomonas vaginalis and Ureaplasma urealyticum DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler MGTVUS is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Mycoplasma genitalium, Trichomonas vaginalis, Ureaplasma urealyticum and Ureaplasma parvum DNA simultaneously in clinical samples.
Ureaplasma urealyticumpathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler UREQ).
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 vaginalisis detected in the corresponding channel of TxR fluorophore and Ureaplasma urealyticum andUreaplasma parvumis detected in the corresponding channel of Alx647 fluorophore.
3 Technical specifications
Sensitivity
- Mycoplasma genitalium: 100 copies/μL.
- Trichomonas vaginalis: 10 copies/μL.
- Ureaplasma urealyticum: 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.
Ureaplasma urealyticum: urease gene.
Ureaplasma parvum: urease gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler MGTVUS includes the AmpliMix dispensed into amplification tubes and a MGTVUS DNA Positive Control, which contains a mixture of Mycoplasma genitalium, Trichomonas vaginalis and Ureaplasma urealyticum DNA.
All reagents are ready to use without adding or rebuilding any component.
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