IRIDICA BAC BSI Assay Clinical Study

  • Research type

    Research Study

  • Full title

    A multicenter observational study to compare IRIDICA BAC BSI Assay results of whole blood specimens on the IRIDICA System to blood culture

  • IRAS ID

    172291

  • Contact name

    Melissa Love

  • Contact email

    melissa.love@abbott.com

  • Duration of Study in the UK

    0 years, 7 months, 31 days

  • Research summary

    This is a multicenter observational study to compare results from the IRIDICA BAC BSI Assay on the IRIDICA System to concurrent blood culture results using whole blood specimens. Participating subjects will have a diagnosis of systemic inflammatory response syndrome (SIRS) and suspicion of blood-stream infection. This patient population is likely to benefit from a fast and accurate assessment of infectious bacteria and fungi, and the associated application of appropriate antimicrobial therapy. The technology used by the IRIDICA System is a new approach to identification with the potential to provide additional information more quickly than current testing. The technology has been studied previously in several research settings.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    15/EM/0214

  • Date of REC Opinion

    15 Jun 2015

  • REC opinion

    Further Information Favourable Opinion