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Lewes, February 27 2006 |
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SeptiFast: New test available for faster results in diagnosis of sepsis
LightCycler SeptiFast Test - Now CE Marked and available in the UK
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Today, sees the launch in the UK of the LightCycler SeptiFast test, a new rapid and reliable test for the detection and identification of 25 different sepsis-causing pathogens. The test, which has been developed by Roche Diagnostics, is the world's first PCR-based test of this kind, and can successfully recognise the infectious pathogens responsible for approximately 90% of all sepsis cases.
Over 23,000 patients in the UK develop severe sepsis each year and with a hospital mortality rate of 45%, for over 10,000 of these people it proves fatal1. This equates more than 27 deaths per day1. Despite improvements in its medical management, sepsis still constitutes one of the greatest challenges in intensive care medicine, with up to 26% of patients being given inappropriate treatment2.
The LightCycler SeptiFast test has the major advantage of being able to detect and identify both bacterial and fungal sepsis pathogens in less than six hours. This offers a significant improvement over the traditional blood culture methods which can take up to two to five days and even then there is a positive test rate of less than 20% for patients with sepsis4. This is an important time saving for targeted medical treatment, as only after pathogens are correctly identified can targeted therapy using a specific antibiotic begin. In addition, the test's capability to detect fungal pathogens is an enormous breakthrough - fungal infections are practically impossible to detect using blood culture, and can take up to eight days to diagnose - accounting for a substantial proportion of fatalities.
A further complication in sepsis diagnosis is the sensitivity of blood cultures, as broad-spectrum antibiotics are administered for suspected sepsis before specific identification of the infecting pathogen, reducing the rate these micro-organisms can grow and be identified in culture. SeptiFast, however, operates on the basis of the Polymerase Chain Reaction (PCR). This method is used to copy repeatedly specific sequences from the genetic material of the pathogen (deoxyribonucleic acid, DNA) so that even small initial quantities can be clearly identified. The test itself is characterised by the MGRADE quality of its reagents, which being free of any contamination with microbial genetic material, ensures that the reliability of the results are not compromised.
Dr Anna Batchelor, Consultant Anaethetist, Royal Victoria Infirmary, Newcastle & President, Intensive Care Society comments, "Slow identification of the organism responsible for a septic episode can lead to delays in appropriate treatment. The Intensive Care Society welcomes any step forward which will assist in the diagnosis and management of patients with sepsis."
references:
1 Intensive Care National Audit and Research Centre. Case Mix Programme Database, 2001. ICNARC data, based on the number of cases identified in the first 24 hours of admission to ICU
2 Kollef MH et al. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb; 115(2):462-74
3 Lisby G et al. Alpha II Results, Presented at Intensive Care Society State of the Art Meeting. 2005
4 Hoffman F. Closing The Fatal Gap, Diagnostics Communications, CH-4070 Basel
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