Pseudomonas aeruginosa + Acinetobacter baumannii + Staphylococcus aureus / blaOXA + blaVIM + blaKPC + blaCTX-M PCR Kit CE/IVD
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RealCycler DRPROA-
Catalog Number: RealCycler DRPROA-
1 Intended use:
RealCycler DRPROA-U / DRPROA-G is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Pseudomonas aeruginosa, Acinetobacter baumannii, Staphylococcus aureus DNA, carbapenemases blaOXA gene, beta-lactamase blaCTX-M gene, metallobetalactamases blaVIM gene and carbapenemases blaKPC genes in clinical samples.
Staphylococcus aureus pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler AURQ).
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 PACISA amplification, Pseudomonas aeruginosa is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Acinetobacter baumannii is detected in the corresponding channel of TxR fluorophore and Staphylococcus aureus is detected in the corresponding channel of Alx647 or Cy5 fluorophore.
In the OCTVIK amplification, blaOXA gene is detected in the corresponding channel of FAM fluorophore, blaCTX-M gene is detected in the corresponding channel of Alx532 or HEX fluorophore,blaVIM gene is detected in the corresponding channel of TxR fluorophore and blaKPC genes are detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity
Pseudomona saeruginosa: 1 copy/μL.
Acinetobacterbaumannii: 5 copies/μL.
Staphylococcusaureus: 10 copies/μL.
blaOXA-48: 10 copies/μL.
blaCTX-M1: 1 copy/μL.
blaCTX-M2: 10 copies/μL.
blaCTX-M9: 1 copy/μL.
blaVIM: 10 copies/μL.
blaKPC: 10 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
Pseudomonas aeruginosa: hcpC, ecfXand gyrBgenes
Acinetobacter baumannii: dnaA gene;
Staphylococcus aureus: NUC gene
blaOXA: blaOXA gene (blaOXA-48, blaOXA-162, blaOXA-163, blaOXA-244, blaOXA-245, blaOXA-247, blaOXA-370 and eventually, other sequences of blaOXA group)
blaCTX-M: blaCTX-M genes (blaCTX-M1, blaCTX-M2, blaCTX-M8, blaCTX-M9 and blaCTX-M25; it is not excluded the detection of other sequences of blaCTX-M 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: blaKPC genes (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 blaCTX-M group).
4 Contents
RealCycler DRPROA-U / DRPROA-G includes the PACISA AmpliMix and OCTVIK AmpliMix, a PACISA DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcusaureus DNA, and an OCTVIK DNA Positive Control which contains a mixture of blaOXA-48, blaCTX-M2, blaCTX-M9, blaVIM and blaKPC DNA. Each sample should be simultaneously analysed with both AmpliMix (PACISA and OCTVIK). OCTVIK AmpliMix cannot be used individually given that CHIC is not included.
All reagents are ready to use without adding or rebuilding any component.
RealCycler DRPROA-U / DRPROA-G is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Pseudomonas aeruginosa, Acinetobacter baumannii, Staphylococcus aureus DNA, carbapenemases blaOXA gene, beta-lactamase blaCTX-M gene, metallobetalactamases blaVIM gene and carbapenemases blaKPC genes in clinical samples.
Staphylococcus aureus pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler AURQ).
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 PACISA amplification, Pseudomonas aeruginosa is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Acinetobacter baumannii is detected in the corresponding channel of TxR fluorophore and Staphylococcus aureus is detected in the corresponding channel of Alx647 or Cy5 fluorophore.
In the OCTVIK amplification, blaOXA gene is detected in the corresponding channel of FAM fluorophore, blaCTX-M gene is detected in the corresponding channel of Alx532 or HEX fluorophore,blaVIM gene is detected in the corresponding channel of TxR fluorophore and blaKPC genes are detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity
Pseudomona saeruginosa: 1 copy/μL.
Acinetobacterbaumannii: 5 copies/μL.
Staphylococcusaureus: 10 copies/μL.
blaOXA-48: 10 copies/μL.
blaCTX-M1: 1 copy/μL.
blaCTX-M2: 10 copies/μL.
blaCTX-M9: 1 copy/μL.
blaVIM: 10 copies/μL.
blaKPC: 10 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
Pseudomonas aeruginosa: hcpC, ecfXand gyrBgenes
Acinetobacter baumannii: dnaA gene;
Staphylococcus aureus: NUC gene
blaOXA: blaOXA gene (blaOXA-48, blaOXA-162, blaOXA-163, blaOXA-244, blaOXA-245, blaOXA-247, blaOXA-370 and eventually, other sequences of blaOXA group)
blaCTX-M: blaCTX-M genes (blaCTX-M1, blaCTX-M2, blaCTX-M8, blaCTX-M9 and blaCTX-M25; it is not excluded the detection of other sequences of blaCTX-M 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: blaKPC genes (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 blaCTX-M group).
4 Contents
RealCycler DRPROA-U / DRPROA-G includes the PACISA AmpliMix and OCTVIK AmpliMix, a PACISA DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcusaureus DNA, and an OCTVIK DNA Positive Control which contains a mixture of blaOXA-48, blaCTX-M2, blaCTX-M9, blaVIM and blaKPC DNA. Each sample should be simultaneously analysed with both AmpliMix (PACISA and OCTVIK). OCTVIK AmpliMix cannot be used individually given that CHIC is not included.
All reagents are ready to use without adding or rebuilding any component.
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