Objective: At present, one of the main medical problems in hospitals is the increasing number of nosocomial (hospital-acquired) infections. Epidemiological data show that a limited number of microorganisms are responsible for the majority of bloodstream infections. Twenty-five species account for more than 90% of all nosocomial pathogens. A rapid diagnosis of Sepsis and the correct identification of the causative pathogen followed by immediate and appropriate antimicrobial therapy is the key of success in the management of bacteraemia and fungaemia in septic patients, but not limited to these. Methods: The LightCycler® SeptiFast Test was developed to detect and differentiate up to 25 pathogenic microbial DNA(s) in human whole blood. Specimen preparation is based on a semi automated procedure using the MagNa Lyser followed by a manual spin column based nucleic acid preparation. Amplification and detection are automated using the LightCycler 2.0 Instrument. Results: Compared to classical methods (blood culture followed by gram staining and species identification based on culture methods), the LightCycler® SeptiFast Test offers an improved sensitivity and a much better time to result. In most cases, the result will be available in about 4.5 hours instead of two to three days. In case of a positive PCR result, therapy can be adjusted about two days earlier, which might lead to significant savings for the hospital as well as to improved outcome for the patient. In case of negative PCR results, blood culture remains the basis for medical decisions. Conclusion: The LightCycler® SeptiFast Test is the first IVD assay using PCR for the rapid detection and identification of bacterial and fungal pathogens involved in nosocomial infections directly from whole blood. Here we present non-clinical performance data as well as selected data from several external clinical studies to illustrate the ability and power of the assay.
Full conference title:
16th European Congress of Clinical Microbiology and Infectious Diseases
- ECCMID 16th (2006)