Background: Escherichia coli is a Gram-negative bacterium inhabiting the normal intestinal flora. Most E. coli strains are non-pathogenic but some strains of this species can cause disease such as urinary tract infections, gastrointestinal infections, or sepsis. Klebsiella species are Gram-negative, facultatively anaerobic bacteria found ubiquitously in the environment. They are part of the healthy gut flora in humans. Outside the intestine they can lead to infections such as pneumonia and sepsis. Some strains show antibiotic resistance and are therefore difficult to treat. Both E. coli and Klebsiella are microorganisms responsible for nosocomial infections.
Description: BactoReal® Kit E. coli & Klebsiella is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Escherichia coli (dxs gene), Klebsiella pneumoniae, K. quasipneumoniae, K. variicola, K. oxytoca and K. aerogenes (khe gene) from samples purified from human EDTA blood, aspirates, CSF and biopsies. A probe-specific amplification curve in the fluorescence channel for FAM or VIC detects the pathogen-specific DNA. The Internal Positive Control (IPC) is detected in the fluorescence channel Cy5 and serves as a control for DNA extraction and possible real-time PCR inhibition. The target for the DNA IPC is added during sample extraction. In combination with other diagnostic tests such as culture the test supports a rapid and specific diagnosis for patients suspected of having a bacterial infection. Results have to be interpreted in context of the overall picture and other clinical parameters. Sepsis diagnosis must not be based solely on BactoReal® Kit E. coli & Klebsiella.
Declaration of Conformity
|Ordernumber||Reactions||Channel Pathogen||Channel IPC||Target|
|DHUS00153||50||FAM, VIC||CY5||dxs + khe|
Shipping Temperature: +4°C cool packs
- Amplification and detection: dxs gene of Escherichia coli and khe gene of Klebsiella pneumoniae, K. quasipneumoniae, K. variicola, K. oxytoca and K. aerogenes
- CE-IVD Real-time PCR with rapid hot-start Taq DNA polymerase
- ROX™ dye as passive reference
- Internal Positive Control System to exclude false-negative results
- Optimized to handle PCR inhibitors
- PCR- platforms: runs on all established standard real-time PCR- platforms
- Harmonized thermal profiles to run RNA and DNA samples simultaneously
PCR platforms: BactoReal® Kit E. coli & Klebsiella is developed and validated for the Applied Biosystems® 7500 System (Thermo Fisher Scientific) and cobas z 480 Analyzer (Roche), but is also suitable for other real-time PCR instruments.