Candida sp. + Trichomonas vaginalis + Gardnerella vaginalis PCR Kit CE/IVD
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RealCycler CSTVGV-
Catalog Number: RealCycler CSTVGV-
1 Intended use:
RealCycler CSTVGV is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Candida sp., Trichomonas vaginalis and Gardnerella vaginalis 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 Candida sp. is detected in the corresponding channel of FAM fluorophore, Trichomonas vaginalis is detected in the corresponding channel of TxRfluorophore, Gardnerella vaginalis is detected in the corresponding channel of Alx647 orCy5 fluorophoreand the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity
- Candida sp.: 500 copies/μL.
- Trichomonas vaginalis: 1 copy/μL.
- Gardnerella vaginalis: 10 copies/μL.
The analytical sensitivity has been determined by limit dilution.
This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
Candida sp.: Internal Transcribed Spacer Regions.
Trichomonas vaginalis: 2-kb repeated sequence.
Gardnerella vaginalis: cpn60 gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
mecC gene.
4 Contents
:RealCycler CSTVGV includes the AmpliMix and a CSTVGV DNA Positive Control which contains a mixture of Candida sp., Trichomonas vaginalis and Gardnerella vaginalis DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler CSTVGV is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Candida sp., Trichomonas vaginalis and Gardnerella vaginalis 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 Candida sp. is detected in the corresponding channel of FAM fluorophore, Trichomonas vaginalis is detected in the corresponding channel of TxRfluorophore, Gardnerella vaginalis is detected in the corresponding channel of Alx647 orCy5 fluorophoreand the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity
- Candida sp.: 500 copies/μL.
- Trichomonas vaginalis: 1 copy/μL.
- Gardnerella vaginalis: 10 copies/μL.
The analytical sensitivity has been determined by limit dilution.
This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
Candida sp.: Internal Transcribed Spacer Regions.
Trichomonas vaginalis: 2-kb repeated sequence.
Gardnerella vaginalis: cpn60 gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
mecC gene.
4 Contents
:RealCycler CSTVGV includes the AmpliMix and a CSTVGV DNA Positive Control which contains a mixture of Candida sp., Trichomonas vaginalis and Gardnerella vaginalis DNA.
All reagents are ready to use without adding or rebuilding any component.
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