blaVIM and blaIMP metallo-beta-lactamase genes PCR Kit CE/IVD
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RealCycler IMVI-
Catalog Number: RealCycler IMVI-
1 Intended use:
RealCycler IMVI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from metallobetalactamases blaIMP and blaVIM 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 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 blaIMP gene is detected in the corresponding channel of FAM fluorophore, blaVIM gene is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity:
- blaIMP: 1 copy/μL and
- blaVIM: 10 copies/μL
Specificity:
- blaIMP: blaIMP genes (blaIMP genes (blaIMP-1, blaIMP-2, blaIMP-6, blaIMP-8, blaIMP-10, blaIMP-11, blaIMP-15, blaIMP-19, blaIMP-20, blaIMP-21, blaIMP-22, blaIMP-24, blaIMP-25, blaIMP-40, blaIMP-41 and blaIMP-42 it is not excluded the detection of other sequences of blaIMP group)) and
- blaVIM: blaVIM genes (blaVIM-1, blaVIM-2, blaVIM-3, blaVIM-4, blaVIM-5, blaVIM-6, blaVIM-8, blaVIM-9, blaVIM-10, blaVIM-11, blaVIM-12, blaVIM-15, blaVIM-16, blaVIM-17, blaVIM-18, blaVIM-19, blaVIM-20, blaVIM-23, blaVIM-24, blaVIM-25, blaVIM-26, blaVIM-27, blaVIM-28, blaVIM-29, blaVIM-30, blaVIM-31, blaVIM-32, blaVIM-33, blaVIM-35, blaVIM-36, blaVIM-37 and blaVIM-38; it is not excluded the detection of other sequences of blaVIM group).
4 Contents
RealCycler IMVI includes the AmpliMix, Internal Control CHIC and an IMVI DNA Positive Control, which contains a mixture of IMP and VIM DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler IMVI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from metallobetalactamases blaIMP and blaVIM 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 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 blaIMP gene is detected in the corresponding channel of FAM fluorophore, blaVIM gene is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity:
- blaIMP: 1 copy/μL and
- blaVIM: 10 copies/μL
Specificity:
- blaIMP: blaIMP genes (blaIMP genes (blaIMP-1, blaIMP-2, blaIMP-6, blaIMP-8, blaIMP-10, blaIMP-11, blaIMP-15, blaIMP-19, blaIMP-20, blaIMP-21, blaIMP-22, blaIMP-24, blaIMP-25, blaIMP-40, blaIMP-41 and blaIMP-42 it is not excluded the detection of other sequences of blaIMP group)) and
- blaVIM: blaVIM genes (blaVIM-1, blaVIM-2, blaVIM-3, blaVIM-4, blaVIM-5, blaVIM-6, blaVIM-8, blaVIM-9, blaVIM-10, blaVIM-11, blaVIM-12, blaVIM-15, blaVIM-16, blaVIM-17, blaVIM-18, blaVIM-19, blaVIM-20, blaVIM-23, blaVIM-24, blaVIM-25, blaVIM-26, blaVIM-27, blaVIM-28, blaVIM-29, blaVIM-30, blaVIM-31, blaVIM-32, blaVIM-33, blaVIM-35, blaVIM-36, blaVIM-37 and blaVIM-38; it is not excluded the detection of other sequences of blaVIM group).
4 Contents
RealCycler IMVI includes the AmpliMix, Internal Control CHIC and an IMVI DNA Positive Control, which contains a mixture of IMP and VIM DNA.
All reagents are ready to use without adding or rebuilding any component.
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