Candida albicans + Candida parapsilosis + Candida glabrata PCR Kit CE/IVD

Candida albicans + Candida parapsilosis + Candida glabrata PCR Kit CE/IVD

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SKU
RealCycler ALPAGL-
Catalog Number: RealCycler ALPAGL-

1 Intended use:
RealCycler ALPAGL is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Candida albicans, Candida parapsilosis and Candida glabrata DNA.
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 Candida albicans is detected in the corresponding channel of FAM fluorophore, Candida parapsilosis in the corresponding channel for the Txr fluorphore, Candida glabrata in the corresponding channel for the Alx647 fluorphore and the internal control is detected in the corresponding channel of Alx532 fluorophore.

3 Technical specifications
Sensitivity:
- Candida albicans: 100 copies/μL
- Candida parapsilosis: 10 copies/μL
- Candida glabrata: 10 copias/μL
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.

Specificity:
- Candida albicans: Internal transcribed spacer ITS2.
- Candida parapsilosis: Internal transcribed spacer ITS2.
- Candida glabrata: rRNA 26S gene

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

4. Contents
RealCycler ALPAGL includes the AmpliMix, a retrotranscriptase and a APAGL DNA Positive Control, which contains a mixture of Candida albicans, Candida parapsilosis and Candida glabrata DNA
All reagents are ready to use without adding or rebuilding any component.
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