Pseudomonas aeruginosa + Enterobacteriaceae + Staphylococcus aureus / blaOXA + blaCTX-M + blaVIM + blaKPC / blaIMP + blaNDM + vanA and vanB + mecA and mecC PCR Kit CE/IVD
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RealCycler ENZERO-
Catalog Number: RealCycler ENZERO-
1 Intended use:
RealCycler ENZERO-U / ENZERO-G is an in vitro diagnostic kit of reagents which allows real-time PCR detection of Pseudomonas aeruginosa, Enterobacteriaceae, Staphylococcus aureus DNA, carbapenemases blaOXA gene, beta-lactamase blaCTX-M gene, metallo-beta-lactamases blaVIM gene, carbapenemases blaKPC genes, metallo-beta-lactamase blaIMP gene, blaNDM gene (New Delhi metallo-beta-lactamase), vancomycin resistant vanA and vanB genes and methicillin resistant mecA and mecC genes in clinical samples.
Staphylococcus aureuspathogen 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 PAENSA amplification, Pseudomonas aeruginosa is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Enterobacteriaceaeis detected in the corresponding channel of TxR fluorophore and Staphylococcus aureusis 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.
In the IMNVAM amplification, blaIMP gene is detected in the corresponding channel of FAM fluorophore, blaNDM gene is detected in the corresponding channel of Alx532 or HEX fluorophore, vanA and vanB genes are detected in the corresponding channel of TxR fluorophore and mecA and mecC genes are detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity
- blaOXA-48: 10 copies/μL.
- blaCTX-M1: 1 copies/μL.
- blaCTX-M2: 10 copies/μL.
- blaCTX-M9: 1 copies/μL.
- blaVIM: 10 copies/μL.
- blaKPC: 10 copies/μL.
- blaIMP: 10 copies/μL.
- blaNDM-1: 50 copies/μL.
- vanA: 50 copies/μL.
- vanB: 1 copy/μL.
- mecA: 100 copies/μL.br /> - mecC: 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, ecfX and gyrB genes.
- Enterobacteriaceae: rpoB gene
- Staphylococcus aureus: NUC gene
- blaOXA: 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).
- 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: 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).
- 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).
blaIMP: 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).
- blaNDM: blaNDM gene.
- vanAgene.
- vanBgene.
- mecAgene.
- mecCgene.
4 Contents
RealCycler ENZERO-U / ENZERO-G includes the PAENSA AmpliMix,OCTVIK AmpliMixand IMNVAM AmpliMix, a PAENSA DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa, Enterobacteriaceae and Staphylococcus aureus DNA, an OCTVIK DNA Positive Control, which contains a mixture of blaOXA-48, blaCTX-M1, blaCTX-M2, blaCTX-M9, blaVIM and blaKPC DNA, and an IMNVAM DNA Positive Control, which contains a mixture of blaIMP, blaNDM-1, vanA, vanB, mecA and mecC DNA. Each sample must be analysed with PAENSA AmpliMix. OCTVIK and IMNVAM AmpliMix cannot be used individually given that CHIC is not included.
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 ENZERO-U / ENZERO-G is an in vitro diagnostic kit of reagents which allows real-time PCR detection of Pseudomonas aeruginosa, Enterobacteriaceae, Staphylococcus aureus DNA, carbapenemases blaOXA gene, beta-lactamase blaCTX-M gene, metallo-beta-lactamases blaVIM gene, carbapenemases blaKPC genes, metallo-beta-lactamase blaIMP gene, blaNDM gene (New Delhi metallo-beta-lactamase), vancomycin resistant vanA and vanB genes and methicillin resistant mecA and mecC genes in clinical samples.
Staphylococcus aureuspathogen 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 PAENSA amplification, Pseudomonas aeruginosa is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Enterobacteriaceaeis detected in the corresponding channel of TxR fluorophore and Staphylococcus aureusis 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.
In the IMNVAM amplification, blaIMP gene is detected in the corresponding channel of FAM fluorophore, blaNDM gene is detected in the corresponding channel of Alx532 or HEX fluorophore, vanA and vanB genes are detected in the corresponding channel of TxR fluorophore and mecA and mecC genes are detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity
- blaOXA-48: 10 copies/μL.
- blaCTX-M1: 1 copies/μL.
- blaCTX-M2: 10 copies/μL.
- blaCTX-M9: 1 copies/μL.
- blaVIM: 10 copies/μL.
- blaKPC: 10 copies/μL.
- blaIMP: 10 copies/μL.
- blaNDM-1: 50 copies/μL.
- vanA: 50 copies/μL.
- vanB: 1 copy/μL.
- mecA: 100 copies/μL.br /> - mecC: 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, ecfX and gyrB genes.
- Enterobacteriaceae: rpoB gene
- Staphylococcus aureus: NUC gene
- blaOXA: 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).
- 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: 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).
- 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).
blaIMP: 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).
- blaNDM: blaNDM gene.
- vanAgene.
- vanBgene.
- mecAgene.
- mecCgene.
4 Contents
RealCycler ENZERO-U / ENZERO-G includes the PAENSA AmpliMix,OCTVIK AmpliMixand IMNVAM AmpliMix, a PAENSA DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa, Enterobacteriaceae and Staphylococcus aureus DNA, an OCTVIK DNA Positive Control, which contains a mixture of blaOXA-48, blaCTX-M1, blaCTX-M2, blaCTX-M9, blaVIM and blaKPC DNA, and an IMNVAM DNA Positive Control, which contains a mixture of blaIMP, blaNDM-1, vanA, vanB, mecA and mecC DNA. Each sample must be analysed with PAENSA AmpliMix. OCTVIK and IMNVAM AmpliMix cannot be used individually given that CHIC is not included.
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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