Evaluation of a new PCR method for targeting carbapenemase-producers

  • Research type

    Research Study

  • Full title

    Laboratory evaluation of a new multiplex PCR for targeting carbapenemase-producing Enterobacteriaceae.

  • IRAS ID

    210479

  • Contact name

    John Perry

  • Contact email

    john.perry@nuth.nhs.uk

  • Sponsor organisation

    Newcastle upon Tyne Hospitals NHS Foundation Trust

  • Duration of Study in the UK

    0 years, 2 months, 29 days

  • Research summary

    Renishaw Diagnostics are currently developing a new test based on a technology known as multiplex PCR for the rapid detection of a type of antibiotic-resistant bacteria known as carbapenemase-producing Enterobacteriaceae (CPE). These bacteria cause infections in hospitalized patients and can spread rapidly in hospitals. They are extremely difficult to treat with antibiotics. The new test will enable quick detection of CPE and help us to stop them spreading in the hospital and between patients.

    Screening for CPE involves testing rectal swabs from patients admitted to hospitals. Newcastle Freeman hospital is collaborating with Renishaw Diagnostics on this project and aims to help with the validation of this new test. The validation will entail creating simulated rectal swab samples that use leftover stool samples from routine diagnostic testing, and inoculating these samples with CPE bacteria. These samples will be used to validate the performance of the new test which in turn will enable Renishaw to obtain CE marking of this test before evaluating it in a clinical study.

  • REC name

    West Midlands - Black Country Research Ethics Committee

  • REC reference

    16/WM/0344

  • Date of REC Opinion

    26 Jul 2016

  • REC opinion

    Favourable Opinion