Bartonella sp + Bartonella henselae PCR Kit CE/IVD

1 Intended Use:
RealCycler BART-U/ BART-G is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Bartonella spp. and Bartonella henselae simultaneously in clinical samples.
hesystemincludesaninternalcontrol 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 Bartonella spp. is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore and Bartonella henselaeis detected in the corresponding channel of TxR fluorophore.

3 Technical specifications
Sensitivity
- Bartonella spp.: 10 copies/μL.
- Bartonella henselae: 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
- Bartonella spp.: groEL gene and
- Bartonella henselae: intergenic spacer alr-gcvP.

4 Contents
RealCycler BART includes the AmpliMix and a BARTI DNA Positive Control, which contains Bartonella henselae DNA.
All reagents are ready to use without adding or rebuilding any component.

Associated diseases
Bartonella spp.: Bacteremia, endocarditis, bacillary angiomatosis, peliosis hepatis, trench fever, Carrion´s disease.
Bartonella henselae: Bacteremia, endocarditis, bacillary angiomatosis, peliosis hepatis, cat scratch disease.

Sample material: Purified DNA from clinical samples.

Nucleic acid purification systems:
Validated:
- QIAamp DNA blood Mini kit. QIAGEN
Compatible:
- Maxwell® 16 Cell LEV DNA Purification kit
- Promega Corporation
- BioRobot EZ1. QIAGEN
- QIAcube, QIAGEN
- NucliSENS® easyMAG®. bioMérieux.
Compatible instruments:
- CFX96. Bio-Rad
- CFX384. Bio-Rad
- iCycler iQ5®. Bio-Rad
- ExiCycler 96. Bioneer
- SmartCycler®. Cepheid
- ABI 7500®. LifeTechnologies
- ABI 7500 Fast®. LifeTechnologies
- iiA7®. LifeTechnologies
- Rotor-Gene 3000®. Qiagen
- Rotor-Gene 6000®. Qiagen
- Rotor-Gene Q®. Qiagen
- LightCycler 2.0®. Roche
- LightCycler 480®. Roche
- MX3000P®. Agilent
- MX3005P®. Agilent
- MX4000P®. Agilent
- BD Max. Becton Dickinson
- Eco Real-Time. Illumina
- MasterCycler ep realplex 4®. Eppendorf
- ABI 7300®. LifeTechnologies
- ABI 7900HT®. LifeTechnologies
- StepOne®. LifeTechnologies
- StepOnePlus®. LifeTechnologies