blaOXA + blaVIM + blaKPC + blaNDM PCR Kit CE/IVD
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RealCycler OXVIKPND-
Catalog Number: RealCycler OXVIKPND-
1 Intended use:
RealCycler OXVIKPND-U / OXVIKPND-G is an in vitro diagnostic kit of reagents which allows real-time PCR detection of carbapenemases blaOXA gene, metallo-beta-lactamases blaVIM gene, carbapenemases blaKPC genes and blaNDM gene (New Delhi metallo-beta-lactamase) simultaneously in clinical samples.
The system includes an internal control CHIC (Competitive Heterologous Internal Control) to prevent false negatives due to reactioninhibition.
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 blaOXAgene is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of HEX fluorophore, blaVIMgene is detected in the corresponding channel of TxR fluorophore, blaKPC genes is detected in the corresponding channel of Cy5 fluorophore and blaNDM gene is detected in the corresponding channel of Cy5.5 fluorophore.
3 Technical specifications
Sensitivity
- blaOXA-48: 10 copies/μL.
- blaVIM: 5 copies/μL.
- blaKPC: 10 copies/μL.
- blaNDM-1: 100 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- blaOXA genes (blaOXA-48, blaOXA-162, blaOXA-163, blaOXA-244, blaOXA-245, blaOXA-247 and blaOXA-370 genes and eventually, other sequences of blaOXA group).
- blaVIM: blaVIMgenes (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).
- blaKPC: blaKPCgenes (blaKPC-1, blaKPC-2, blaKPC-3, blaKPC-4, blaKPC-5, blaKPC-6, blaKPC-7, blaKPC-8, blaKPC-9, blaKPC-10, blaKPC-11, blaKPC-12, blaKPC-13, blaKPC-14 and blaKPC-15; it is not excluded the detection of other sequences of blaKPC group).
- blaNDM: blaNDM gene.
4 Contents
RealCycler OXVIKPND-U / OXVIKPND-G includes the OXVIKPND AmpliMix and an OXVIKPND DNA Positive Control, which contains a mixture of blaOXA-48, blaVIM, blaKPC and blaNDM-1 DNA.
All reagents are ready to use without adding or rebuilding any component.
All reagents are ready to use without adding or rebuilding any component.
RealCycler OXVIKPND-U / OXVIKPND-G is an in vitro diagnostic kit of reagents which allows real-time PCR detection of carbapenemases blaOXA gene, metallo-beta-lactamases blaVIM gene, carbapenemases blaKPC genes and blaNDM gene (New Delhi metallo-beta-lactamase) simultaneously in clinical samples.
The system includes an internal control CHIC (Competitive Heterologous Internal Control) to prevent false negatives due to reactioninhibition.
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 blaOXAgene is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of HEX fluorophore, blaVIMgene is detected in the corresponding channel of TxR fluorophore, blaKPC genes is detected in the corresponding channel of Cy5 fluorophore and blaNDM gene is detected in the corresponding channel of Cy5.5 fluorophore.
3 Technical specifications
Sensitivity
- blaOXA-48: 10 copies/μL.
- blaVIM: 5 copies/μL.
- blaKPC: 10 copies/μL.
- blaNDM-1: 100 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- blaOXA genes (blaOXA-48, blaOXA-162, blaOXA-163, blaOXA-244, blaOXA-245, blaOXA-247 and blaOXA-370 genes and eventually, other sequences of blaOXA group).
- blaVIM: blaVIMgenes (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).
- blaKPC: blaKPCgenes (blaKPC-1, blaKPC-2, blaKPC-3, blaKPC-4, blaKPC-5, blaKPC-6, blaKPC-7, blaKPC-8, blaKPC-9, blaKPC-10, blaKPC-11, blaKPC-12, blaKPC-13, blaKPC-14 and blaKPC-15; it is not excluded the detection of other sequences of blaKPC group).
- blaNDM: blaNDM gene.
4 Contents
RealCycler OXVIKPND-U / OXVIKPND-G includes the OXVIKPND AmpliMix and an OXVIKPND DNA Positive Control, which contains a mixture of blaOXA-48, blaVIM, blaKPC and blaNDM-1 DNA.
All reagents are ready to use without adding or rebuilding any component.
All reagents are ready to use without adding or rebuilding any component.
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