Aspergillus fumigatus PCR Kit CE/IVD

Aspergillus fumigatus PCR Kit CE/IVD

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SKU
RealCycler FUMI-
Catalog Number: RealCycler FUMI-

1 Intended use:
RealCycler FUMI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Aspergillus fumigatus in clinical samples.

Aspergillus fumigatus pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler FUMQ).

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 Aspergillus fumigatus is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore

3 Technical specifications
Sensitivity: Aspergillus fumigatus: 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: Aspergillus fumigatus: ITS1 region.

Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).

The presence of other species of the genus Aspergillusin the sample at high concentration, could generate a positive result with a Ct close to 40.<

strong>4. Contents
RealCycler FUMI-G/FUMI-U includes the FUMI AmpliMix and an Aspergillus fumigatus DNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.

Associated diseases; Bronchopulmonary aspergillosis in immunosuppressed patients, allergic alveolitis and rhinitis, asthma, aspergilloma.

Sample material: Purified DNA from clinical samples.
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