BactoReal® kit P. aeruginosa & Enterobacter spp. (Module 5)

Detection of the 16S rRNA gene of P. aeruginosa and the rpoB gene of Enterobacter spp.

Background: Pseudomonas spp. are Gram-negative rod bacteria found in soil, water and plants. In healthy individuals, they do not cause infection, but immunocompromised people can be infected. Pseudomonas aeruginosa as well as other Pseudomonas species such as P. paucimobilis, P. putida, P. fluorescens or P. acidovorans cause nosocomial and antibiotic-resistant infections which are difficult to treat and can be life-threatening. Pseudomonas infections can lead to sepsis, with P. aeruginosa being the most common species. Pseudomonas bacteremia is indicative of contaminated infusion solutions, medications or disinfectants used in the placement of intravenous catheters. Pseudomonas aeruginosa is also responsible for wound infection and bacteremia in burn patients, with high rates of multidrug resistance. Enterobacter species are Gram-negative bacteria causing a wide variety of nosocomial infections, including those affecting the lungs, urinary tract, intrabdominal cavity and intravascular devices. Enterobacter asburiae can be detected in urine, stool and blood samples. E. bugandensis can cause neonatal sepsis. E. cloacae can lead to wound infections and catheter-associated urinary tract infections and is often resistant to antibiotics. E. ludwigii and E. roggenkampii belong to the Enterobacter cloacae complex. Enterobacter huaxiensis, E. chuandaensis and E. chengduensis were discovered in the last few years in China and can cause sepsis. E. oligotrophica is an oligotrophic bacterium and has been recently isolated in Japan. E. sichuanensis was isolated in 2016 from a urine sample taken from a patient in China.

Description: BactoReal® Kit P. aeruginosa & Enterobacter spp. is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Pseudomonas aeruginosa (16S rRNA gene) and Enterobacter spp. (rpoB gene) from samples purified from human EDTA blood, CSF aspirates 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 P. aeruginosa & Enterobacter 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: 16S rRNA gene of P. aeruginosa and the rpoB gene of Enterobacter species
- 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