BactoReal® Kit Staphylococcus spp. & S. aureus (Module 3)

Detection of the lytA gene of S. pneumoniae and the 23S rRNA gene of Streptococcus spp.

Background: Streptococcus is a genus of Gram-positive bacteria belonging to the Firmicutes and the lactic acid bacteria group. There are currently over 50 species known in this genus. Many streptococcal species are nonpathogenic and form part of the commensal animal or human microbiome of the mouth, skin, intestine, and upper respiratory tract. Certain Streptococcus species are responsible for streptococcal pharyngitis, pink eye, meningitis, sepsis, bacterial pneumonia, endocarditis, erysipelas and necrotizing fasciitis. Streptococcus pneumoniae (pneumococcus) can cause ambulatory acquired pneumonia, bronchitis, middle ear infections, meningitis and sepsis. Pneumococci colonize the mucous membranes of the upper respiratory tract. The carrier rate in healthy adults varies between 40% and 70%. Transmission takes place via droplet infection. The pathogens mostly lead to infections if the immune system is weakened.

Description: BactoReal® Kit S. pneumoniae & Streptococcus spp. is a non-automatic in-vitro diagnostic real-time PCR test for the qualitative detection and identification of extracted DNA of Streptococcus pneumoniae (lytA gene) und Streptococcus 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 S. pneumoniae & Streptococcus spp..
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: 23S rRNA gene of Streptococcus species and the lytA gene of Streptococcus pneumoniae
- 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