BactoReal® Kit vanA & Enterococcus spp. (Module 4)

Detection of the vanA resistance gene and the 23S rRNA gene of Enterococcus spp.

Background: Enterococci are Gram-positive, catalase-negative and anaerobic bacteria that play an important role in the digestive system. In immunocompromised individuals, enterococci can lead to urinary tract infections, wound infections and even sepsis. Enterococci are often resistant to vancomycin. Enterococcus faecalis and Entercoccus faecium are the best-known representatives of the Enterococcus species. They are used to promote the intestinal flora in probiotic food. However, in people with a weakened immune system, these bacteria can lead to severe infections, including catheter-associated urinary tract infections and sepsis. Enterococcus casseliflavus, Enterococcus durans and Enterococcus hirae can rarely lead to infections in humans. Enterococcus avium is often found in birds but can lead to infections in humans and may be resistant to vancomycin. Enterococcus gallinarum has a low resistance to vancomycin and in rare cases it can lead to infections in humans ranging from meningitis to sepsis.

Description: BactoReal® Kit vanA & Enterococcus spp. is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Enterococcus spp. (23S rRNA gene) as well as of the vanA resistance gene of Enterococcus 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 it 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 vanA & Enterococcus spp..
Our carefully designed primers and probe ensure highest sensitivity and specificity. The kit consists of an assay mix for the detection of the pathogen as well as a positive control and an internal positive control (IPC). To minimize PCR cross-contamination, the reaction mix included contains dUTP and uracil-N glycosylase (UNG).

Product Features:
- Amplification and detection: 23S rRNA gene of Enterococcus spp. and vanA resistance gene of Enterococcus and some other pathogens
- 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
-Declaration of Conformity