Leishmania donovani complex PCR Kit CE/IVD
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SKU
RealCycler DONO-
Catalog Number: RealCycler DONO-
1 Intended use:
RealCycler DONO is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Leishmania donovani and Leishmania infantum 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 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 Leishmania is detected in the corresponding channel of FAM fluorophore and CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore
3 Technical specifications
Sensitivity: 10 copies/µL Leishmania donovani and 1 copy/µL Leishmania infantum.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity: Leishmania donovani: TOP2 gene and Leishmania infantum:TOP2 gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
Cross reactivity with others Leishmania genus species couldn´t be demostrated.
4. Contents
RealCycler DONO-U includes the AmpliMix and a Leishmania DNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.
Publications and Posters
11-2012: Oral presentation at the XXV meeting of the Clinical Microbiology and Parasitology Andalusian Society, SAMPAC (Almería)
"Comparison of two screening methods for visceral leishmania" Link
RealCycler DONO is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Leishmania donovani and Leishmania infantum 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 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 Leishmania is detected in the corresponding channel of FAM fluorophore and CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore
3 Technical specifications
Sensitivity: 10 copies/µL Leishmania donovani and 1 copy/µL Leishmania infantum.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity: Leishmania donovani: TOP2 gene and Leishmania infantum:TOP2 gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
Cross reactivity with others Leishmania genus species couldn´t be demostrated.
4. Contents
RealCycler DONO-U includes the AmpliMix and a Leishmania DNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.
Publications and Posters
11-2012: Oral presentation at the XXV meeting of the Clinical Microbiology and Parasitology Andalusian Society, SAMPAC (Almería)
"Comparison of two screening methods for visceral leishmania" Link
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