blaOXA-48 / blaVIM / blaKPC PCR Kit CE/IVD
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RealCycler OXVIKP-
Catalog Number: RealCycler OXVIKP-
1 Intended use:
RealCycler OXVIKP is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of carbapenemases blaOXA-48 gene, metallobetalactamases blaVIM gene and carbapenemases blaKPC genes 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 fluorophoresthat 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 blaOXA-48 gene is detected in the corresponding channel of FAM fluorophore, blaVIM gene is detected in the corresponding channel of TxR fluorophore, blaKPC genes is detected in the corresponding channel of Alx647 or Cy5 fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity
- OXA-48: 100 copies/μL.
- VIM: 100 copies/μL.
- KPC: 1000 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- blaOXAgenes (blaOXA-48, blaOXA-162, blaOXA-163, blaOXA-244, blaOXA-245, blaOXA-247 and blaOXA-370 genes and eventually, other sequences of blaOXA group).
- VIM: blaVIM gene.
- KPC: blaKPC genes.
4 Contents
RealCycler OXVIKP-U / OXVIKP-G includes the AmpliMix and an OXVIKP DNA Positive Control, which contains a mixture of blaOXA-48, blaVIMand blaKPCDNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler OXVIKP is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of carbapenemases blaOXA-48 gene, metallobetalactamases blaVIM gene and carbapenemases blaKPC genes 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 fluorophoresthat 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 blaOXA-48 gene is detected in the corresponding channel of FAM fluorophore, blaVIM gene is detected in the corresponding channel of TxR fluorophore, blaKPC genes is detected in the corresponding channel of Alx647 or Cy5 fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity
- OXA-48: 100 copies/μL.
- VIM: 100 copies/μL.
- KPC: 1000 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- blaOXAgenes (blaOXA-48, blaOXA-162, blaOXA-163, blaOXA-244, blaOXA-245, blaOXA-247 and blaOXA-370 genes and eventually, other sequences of blaOXA group).
- VIM: blaVIM gene.
- KPC: blaKPC genes.
4 Contents
RealCycler OXVIKP-U / OXVIKP-G includes the AmpliMix and an OXVIKP DNA Positive Control, which contains a mixture of blaOXA-48, blaVIMand blaKPCDNA.
All reagents are ready to use without adding or rebuilding any component.
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