Pioneering Testing Platform Rapidly Identifies Life-Threatening Infections

Initial results suggest that an innovative testing platform for identifying microorganisms can produce results consistent with the current standard of care in just hours.

The innovative platform, which is under development, promises to provide new hope for critically ill patients with infections and potentially change the way infections are diagnosed around the world which can often take several days.

European scientists led by Université Libre de Bruxelles (Belgium) retrospectively analyzed samples from more than 180 critically ill patients with suspected severe infections from the United Kingdom, France, Belgium, Poland, Switzerland and Germany as part of the Rapid Diagnosis of Infections in the Critically Ill (RADICAL) study.

The study compared their results of culture isolation methods with a testing platform called IRIDICA being developed by Abbott Laboratories (Abbot Park, IL, USA). The team found that the sensitivity of the Abbott technology for blood stream infection and pneumonia assays, which were the primary focus of the study, were 88% and 91%, respectively, when compared to culture techniques. The Abbott technology was able to detect other pathogens that the initial culture missed in many patients. An adjudication panel reported they would have prescribed a different course of treatment in more than 50% of the cases evaluated after reviewing the IRIDICA results.

Additionally, the negative predictive values, the probability patients with a negative result do not have an infection, were 98% and 97% respectively. This information could enable physicians to more confidently and quickly rule out the source of infection. Although time was not a focus of the study, IRIDICA is being designed to produce results in approximately eight hours versus days.

The Abbott technology is being designed to identify hundreds of bacteria and Candida species from a direct patient specimen in approximately eight hours. The RADICAL study is expected to be completed in late 2014, and IRIDICA is expected to be available as a Conformité Européenne (CE)-marked in vitro diagnostic device in European countries within the next 12 months.

Jean-Louis Vincent, MD, PhD, a professor of intensive care and the study author, said, “Every minute can count when diagnosing and treating serious infections. The interim RADICAL results provide increasing evidence that Abbott’s platform may be used for critically ill patients with infections to quickly identify microorganisms before laboratory cultures can detect similar results.”

Related Links:
Université Libre de Bruxelles 
Abbott Laboratories