Pseudomonas aeruginosa + Acinetobacter baumannii + Staphylococcus aureus / blaOXA + blaCTX-M + blaVIM + blaKPC / blaIMP + blANDM-1 + vanA and vanB + mecA and mecC PCR Kit CE/IVD

Pseudomonas aeruginosa + Acinetobacter baumannii + Staphylococcus aureus / blaOXA + blaCTX-M + blaVIM + blaKPC / blaIMP + blANDM-1 + vanA and vanB + mecA and mecC PCR Kit CE/IVD

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RealCycler REZERO-
Catalog Number: RealCycler REZERO-

1 Intended use:
RealCycler REZERO is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA fromPseudomonas aeruginosa, Acinetobacter baumannii, Staphylococcus aureus, carbapenemase blaOXA gene (blaOXA-48, blaOXA-162, blaOXA-163, blaOXA-244, blaOXA-245, blaOXA-247 and blaOXA-370 and, eventually, other sequences from blaOXA group), beta-lactamase blaCTX-M gene, metallo-beta-lactamases blaVIM gene, carbapenemases blaKPC, beta-lactamase gene blaIMP, blaNDM-1 (New Delhi metallobetalactamse) gen and resistance to vancomycin vanA and vanB genes and resistance to methicilin mecA and mecC genes detection 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 PACISA amplification Pseudomonas aeruginosa is detected in the corresponding channel of FAM fluorophore, Acinetobacter baumannii is detected in the corresponding channel of TxR fluorophore, Staphylococcus aureus is detected in the corresponding channel of Alx647 fluorophore and the internal control is detected in the corresponding channel of Alx532 fluorophore.
In the OCTVIK amplification the blaOXA gene is detected in the corresponding channel of FAM fluorophore, the blaCTX-M gene is detected in the corresponding channel of Alx532 or HEX fluorophore, the blaVIM gene is detected in the corresponding channel of TxR fluorophore, blaKPC is detected in the corresponding channel of Alx647 fluorophore.
In the IMNVAM amplification the blaIMP gene is detected in the corresponding channel of FAM fluorophore, the blaNDM-1 is detected in the corresponding channel of Alx532 or HEX fluorophore, the vanA and vanB genes are detected in the corresponding channel of TxR fluorophore, and the macA and mecC genes are detected in the corresponding channel of Alx647 or Cy5fluorophore.

3 Technical specifications
Sensitivity
- Pseudomonas aeruginosa: 100 copias/μL.
- Acinetobacter baumannii: 10 copias/μL.
- Staphylococcus aureus: 100 copias/μL.
- blaOXA-48: 10 copias/μL.
- blaCTX-M1: 1 copia/μL.
- blaCTX-M2: 10 copias/μL.
- blaCTX-M9: 1 copia/μL.
- blaVIM: 10 copias/μL.
- blaKPC: 10 copias/μL.
- blaIMP: 10 copias/μL.
- blaNDM-1: 50 copias/μL.
- vanA: 50 copias/μL.
- vanB: 1 copia/μL.
- mecA: 100 copias/μL.
- mecC: 10 copias/μL
Specificity:
Pseudomonas aeruginosa: hcpC gene.
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 genes of the blaOXA group).
blaCTX-M: blaCTX-M gene.
blaVIM: blaVIM gene.
blaKPC: blaKPC gene.
blaIMP: blaIMP gene.
blaNDM-1: blaNDM-1 gene.
vanA gene.
vanB gene.
mecA gene.
mecC gene.

4 Contents:
PACISA (Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcus aureus) AmpliMix - OCTVIK (blaOXA-48, blaCTX-M1, blaCTX-M2, blaCTX-M9, blaVIM and blaKPC) AmpliMix - IMNVAM (blaIMP, blaNDM-1, vanA and vanB, mecA and mecC) AmpliMix - PACISA DNA Positive Control: mixture of Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcus aureus DNA - OCTVIK DNA Positive Control: mixture of blaOXA-48, blaCTX-M1, blaCTX-M2, blaCTX-M9, blaVIM and blaKPC DNA - IMNVAM DNA Positive Control: mixture of blaIMP, blaNDM-1, vanA and vanB, mecA and mecC DNA.
All reagents are ready to use without adding or rebuilding any component.

Sample material: Purified DNA from clinical samples.
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