Serodiagnosis of MAC lung disease

  • Research type

    Research Study

  • Full title

    A new mycolic-acid blood test for Mycobacterium Avium Complex lung disease



  • Contact name

    James Brown

  • Contact email

  • Sponsor organisation

    Royal Free London NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    This study will evaluate a new blood test to detect lung infection with Mycobacterium Avium Complex (MAC) species: these are a group closely-related mycobacteria that can sometimes cause lung infection, usually in people with another underlying problem with their lungs or immune system.

    Non-tuberculous mycobacterial lung infections can be difficult to diagnose: making a diagnosis requires culture of the mycobacteria from sputum samples, or invasive sampling such as via bronchoscopy, but culture of samples is not always positive even when the infection is there, so multiple samples need to be sent. An easier way of diagnosing or excluding MAC lung disease would therefore help patient care.

    One of the collaborators in this project (Diagnostig Ltd) has developed a new way of testing for mycobacterial infections. Mycobacteria have distinctive components of their cell walls called mycolic acids, which are different for each species of mycobacteria. Diagnostig can create synthetic versions of these mycolic acids, which can then be used to detect the presence of antibodies against these mycolic acids in blood samples, as the immune systems of people with these infections will make antibodies in an attempt to clear the infections.

    This study will evaluate this new blood test. We will recruit people who are either known to have this infection, or have a condition such as bronchiectasis that puts them at risk of getting it and take a blood sample which will be tested using the new technique. We will determine the proportion of people with the infection who are correctly identified (the sensitivity of the test) and the proportion of people without the infection who have a negative test result (the specificity of the test).

    This will be the first time that this test for Mycobacterium Avium Complex has been studied.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    4 Mar 2024

  • REC opinion

    Further Information Favourable Opinion