blaCTX-M1 + blaCTX-M2 + blaCTX-M9 PCR Kit CE/IVD
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SKU
RealCycler BLACTX-
Catalog Number: RealCycler BLACTX-
1 Intended use:
RealCycler BLACTX is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of ESBL groups CTX-M1, CTX-M2 and CTX-M9 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 CTX-M1 is detected in the corresponding channel of FAM fluorophore, CTX-M2 is detected in the corresponding channel of TxR fluorophore, CTX-M9 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
- CTX-M1: 10(4) copies/μL.
- CTX-M2: 10(4) copies/μL.
- CTX-M9: 10(3) copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity: ESBL CTX-M1, M2 and M9: beta-lactamase CTX-M gene.
4 Contents
RealCycler BLACTX includes the AmpliMix and a BLACTX DNA Positive Control, which contains a mixture of CTX-M1, CTX-M2 and CTX-M9 DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler BLACTX is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of ESBL groups CTX-M1, CTX-M2 and CTX-M9 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 CTX-M1 is detected in the corresponding channel of FAM fluorophore, CTX-M2 is detected in the corresponding channel of TxR fluorophore, CTX-M9 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
- CTX-M1: 10(4) copies/μL.
- CTX-M2: 10(4) copies/μL.
- CTX-M9: 10(3) copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity: ESBL CTX-M1, M2 and M9: beta-lactamase CTX-M gene.
4 Contents
RealCycler BLACTX includes the AmpliMix and a BLACTX DNA Positive Control, which contains a mixture of CTX-M1, CTX-M2 and CTX-M9 DNA.
All reagents are ready to use without adding or rebuilding any component.
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