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Evaluation of a novel ELISA test using synthetic mycolic acid antigens for serodiagnosis of non-tuberculous mycobacterial (NTM) infections
  1. Julia Bashford1,
  2. William Flowers1,2,
  3. Charles Haworth1,
  4. Judy Ryan1,2,
  5. Anna Cervi3,
  6. J R Al Dulayymi4,
  7. Paul S Mason3,
  8. Ashley Plank5,
  9. Mark Baird3,
  10. Andres Floto1,2
  1. 1Cambridge Centre for Lung Infection, Royal Papworth Hospital NHS Trust, Cambridge, UK
  2. 2Molecular Immunity Unit, Department of Medicine, University of Cambridge, Cambridge, UK
  3. 3Diagnostig Ltd, MSParc, Gaerwen Anglesey, Wales, UK
  4. 4School of Natural Sciences, Bangor University, Bangor, Wales, UK
  5. 5Icon Cancer Foundation, Brisbane, Queensland, Australia
  1. Correspondence to Professor Andres Floto, Molecular Immunity Unit, Department of Medicine, University of Cambridge, Cambridge, UK; arf27{at}cam.ac.uk

Abstract

The diagnosis of non-tuberculous mycobacteria (NTM) is a particular challenge in people with cystic fibrosis. Current standard diagnostic approaches rely on serial sputum culture, which is resource demanding, dependent on patient expectoration and may be compromised by excessive decontamination, conventional bacterial overgrowth and masking by concomitant oral and nebulised antibiotics. An alternative rapid, reliable and inexpensive diagnostic method is therefore urgently needed. Serum of patients with Mycobacterium abscessus infection and chronic suppurative lung disease without NTM infection was tested against an array of novel synthetic mycolic acids, identical or similar to natural components of mycobacterial cell walls, and glycopeptidolipid (GPL)-core antigen, which has previously been investigated in Mycobacterium avium pulmonary infection. Diagnostic accuracy of individual antigens and combination of various antigens were calculated. An ELISA using individual trehalose dimycolates and GPL-core antigen was able to effectively distinguish serum from infected and non-infected individuals with a specificity of 88% and a sensitivity of up to 88%, which increased to 88% sensitivity and 93% specificity by combining several antigens in the test. These results suggest synthetic mycolic acid antigens, used individually or in combination with GPL-core antigen could be successfully used to distinguish patients with M. abscessus infection from disease controls.

  • Cystic Fibrosis
  • Atypical Mycobacterial Infection
  • Bronchiectasis

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Footnotes

  • Twitter @Judy Ryan, @Flotocambridge

  • Contributors AF, MB, JR and JB designed the project. JB, WF selected, recruited and consented participants. MB, JRAD, PSM, AC designed and performed the experiment. AP provided statistical support. JB, WF, CH, AF, MB, AP wrote and corrected the manuscript.

  • Funding This work was supported by Innovate UK through project support (104636) and the Cystic Fibrosis Trust via a Venture and Innovation Award (2018).

  • Competing interests MB and JRAD and shareholders in Diagnostig and are associated with Bangor University.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.