BactoReal® Kit Staphylococcus spp. & S. aureus (Module 2)

Detection of the 23S rRNA gene of Staphylococcus spp. and the nuc gene of S. aureus.

Background: Staphylococcus aureus is a Gram-positive bacterium, which can be found on skin and in mucous membranes. This bacterium can cause pneumonia, meningitis and sepsis and is a microorganism responsible for nosocomial infections. Some strains are resistant to antibiotics like methicillin and vancomycin and therefore more difficult to treat. Staphylococcus epidermidis is a Gram-positive bacterium colonizing skin and mucous membranes of humans. It can lead to infections through various implanted medical devices such as joint prostheses, cardiovascular devices or heart valves. Staphylococcus saprophyticus can lead to urinary tract infections, with young women being more severely affected. Other species of staphylococci such as S. lugdunensis, S. haemolyticus, S. warneri, S. schleiferi, S. intermedius are generally non-pathogenic but can lead to infections in rare cases.

Description: BactoReal® Kit Staphylococcus & S. aureus is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Staphylococcus aureus (nuc gene) and Staphylococcus spp. (23S rRNA 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 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 Staphylococcus & S. aureus.
Our carefully designed primers and probe ensure high 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: nuc gene of Staphylococcus aureus and 23S rRNA gene of Staphylococcus spp.
- 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