Escherichia coli, BLEAS group M1, BLEAS group M2 and BLEAS group M9 PCR Kit CE/IVD
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RealCycler CTXE-
Catalog Number: RealCycler CTXE-
1 Intended use:
RealCycler CTXE is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from E.coli and ESBL group CTX-M1 and ESBL groups CTX-M2 and CTX-M9 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).
In the ECM1 amplification, Escherichia coli is detected in the corresponding channel of FAM fluorophore, CTX-M1 is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
In the M2M9 amplification, CTX-M2 is detected in the corresponding channel of FAM fluorophore, CTX-M9 is detected in the corresponding channel of TxR fluorophore and the internal control isdetected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity
- E.coli: 1000 copies/μL,
- blaCTX-M1: 10,000 copies/μL,
- blaCTX-M2: 1000 copies/μL and
- bla-CTX-M9: 1000 copies/μL.
Specificity:
- E.coli (N-acetylgalactosamine-6-phosphate deacetylase gene) and
- ESBL CTX-M1, M2 and M9: beta-lactamase CTX-M gene
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler CTXE includes the ECM1 AmpliMix, M2M9 AmpliMix, an ECM1 DNA Positive Control, which contains a mixture of E.coli and CTX-M1 DNA and M2M9 DNA Positive Control, which contains a mixture of CTX-M2 and CTX-M9 DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler CTXE is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from E.coli and ESBL group CTX-M1 and ESBL groups CTX-M2 and CTX-M9 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).
In the ECM1 amplification, Escherichia coli is detected in the corresponding channel of FAM fluorophore, CTX-M1 is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
In the M2M9 amplification, CTX-M2 is detected in the corresponding channel of FAM fluorophore, CTX-M9 is detected in the corresponding channel of TxR fluorophore and the internal control isdetected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity
- E.coli: 1000 copies/μL,
- blaCTX-M1: 10,000 copies/μL,
- blaCTX-M2: 1000 copies/μL and
- bla-CTX-M9: 1000 copies/μL.
Specificity:
- E.coli (N-acetylgalactosamine-6-phosphate deacetylase gene) and
- ESBL CTX-M1, M2 and M9: beta-lactamase CTX-M gene
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler CTXE includes the ECM1 AmpliMix, M2M9 AmpliMix, an ECM1 DNA Positive Control, which contains a mixture of E.coli and CTX-M1 DNA and M2M9 DNA Positive Control, which contains a mixture of CTX-M2 and CTX-M9 DNA.
All reagents are ready to use without adding or rebuilding any component.
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