Neisseria meningitidis + Streptococcus pneumoniae + Haemophilus influenzae PCR Kit CE/IVD
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SKU
RealCycler MENEHI-
Catalog Number: RealCycler MENEHI-
1 Intended use:
RealCycler MENEHI-U / MENEHI-G is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae DNA in clinical samples.
Streptococcus pneumoniae pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler NEUQ).
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 Neisseria meningitidis is detected in the corresponding channel of FAM fluorophore and CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Streptococcus pneumoniae is detected om the corresponding channel of the TxR fluorophoreand Haemophilus influenzae is detected in the corresponding channel of the Alx647 fluorophore.
3 Technical specifications
Sensitivity:
- Neisseria meningitidis: 10 copies/μL.
- Streptococcus pneumoniae: 10 copies/μL.
- Haemophilus influenzae: 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:
- Neisseria meningitidis: ctrA gene.
- Streptococcus pneumoniae: ply gene.
- Haemophilus influenzae: fuck gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
Some species of the viridansgroup streptococci (S. mitis, S. pseudopneumoniae and others) can present cross-reactivity with Streptococcus pneumoniae and generate a positive result.
4. Contents
RealCycler MENEHI-U / MENEHI-G includes the AmpliMix and a MENEHI DNA Positive Control, which contains a mixture of Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae DNA and the Internal Control CHIC.
All reagents are ready to use without adding or rebuilding any component.
Sample material: Purified DNA from clinical samples.
RealCycler MENEHI-U / MENEHI-G is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae DNA in clinical samples.
Streptococcus pneumoniae pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler NEUQ).
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 Neisseria meningitidis is detected in the corresponding channel of FAM fluorophore and CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Streptococcus pneumoniae is detected om the corresponding channel of the TxR fluorophoreand Haemophilus influenzae is detected in the corresponding channel of the Alx647 fluorophore.
3 Technical specifications
Sensitivity:
- Neisseria meningitidis: 10 copies/μL.
- Streptococcus pneumoniae: 10 copies/μL.
- Haemophilus influenzae: 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:
- Neisseria meningitidis: ctrA gene.
- Streptococcus pneumoniae: ply gene.
- Haemophilus influenzae: fuck gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
Some species of the viridansgroup streptococci (S. mitis, S. pseudopneumoniae and others) can present cross-reactivity with Streptococcus pneumoniae and generate a positive result.
4. Contents
RealCycler MENEHI-U / MENEHI-G includes the AmpliMix and a MENEHI DNA Positive Control, which contains a mixture of Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae DNA and the Internal Control CHIC.
All reagents are ready to use without adding or rebuilding any component.
Sample material: Purified DNA from clinical samples.
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