Sepsis: Broad-spectrum PCR-Test receives CE-IVD approval

01-10-2008: SepsiTest™ is a novel PCR test for early and rapid diagnosis of sepsis. In less than four hours the broad-spectrum screening assay detects more than 345 relevant sepsis germs. Today’s conventional microbiological methods usually deliver results, on an average, only after 48 hours. SepsiTest™ received CE-IVD-marking according to European in-vitro diagnostic law and is now available for routine sepsis diagnostics.

Sepsis (coll. blood poisoning) is a systemic inflammation of the whole body ultimately leading to multiple organ dysfunctions. Even though the latest intensive care technology can maintain organ function in critical phases for some time, sepsis is an extremely severe prognosis. Despite greatest efforts, septicemic patients today still have a mortality rate of 30-50%. Several researchers have estimated that, in the U.S. alone, more than 580 patients die from sepsis every day. The survival rate greatly depends on an early therapy including targeted antibiotic treatment.

Today, sepsis-causing pathogens are usually identified by a traditional microbiological method: the so-called blood culture. Blood culture tests normally deliver results after 2 to 5 days and, in some cases, the analysis takes even longer. Moreover, blood cultures are limited when detecting fastidious organisms or when antibiotic therapies have already been administered. Therefore, molecular biologists have been working for quite some time on rapid sepsis screening technologies. In contrast to other molecular tests, the broad-spectrum SepsiTest™ detects all relevant pathogens and, thus, for the first time enables very targeted antibiotic therapies. Latest research from SepNet, the European sepsis network, showed dramatically increased survival rates for sepsis patients receiving early and targeted antibiotic treatments.