Maria Paraskevaidi1, Simon J S Cameron2, Eilbhe Whelan3, Sarah Bowden3, Menelaos Tzafetas4, Anita Mitra4, Anita Semertzidou3, Antonis Athanasiou3, Phillip R Bennett5, David A MacIntyre6, Zoltan Takats7, Maria Kyrgiou8. 1. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom; Department of Pharmacy and Biomedical Sciences, University of Central Lancashire, Preston PR1 2HE, United Kingdom. 2. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom; Institute for Global Food Security, School of Biological Sciences, Queen's University, Belfast, Northern Ireland BT5 9DL, United Kingdom. 3. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom. 4. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom. 5. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom; March of Dimes European Preterm Birth Research Centre, Imperial College London, London W12 0NN, United Kingdom. 6. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom; March of Dimes European Preterm Birth Research Centre, Imperial College London, London W12 0NN, United Kingdom. 7. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom. Electronic address: z.takats@imperial.ac.uk. 8. Department of Metabolism, Digestion and Reproduction & Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, 665 Sir Alexander Fleming Building, South Kensington Campus, London W12 0NN, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom. Electronic address: m.kyrgiou@imperial.ac.uk.
Abstract
BACKGROUND: The introduction of high-risk human papillomavirus (hrHPV) testing as part of primary cervical screening is anticipated to improve sensitivity, but also the number of women who will screen positive. Reflex cytology is the preferred triage test in most settings but has limitations including moderate diagnostic accuracy, lack of automation, inter-observer variability and the need for clinician-collected sample. Novel, objective and cost-effective approaches are needed. METHODS: In this study, we assessed the potential use of an automated metabolomic robotic platform, employing the principle of laser-assisted Rapid Evaporative Ionisation Mass Spectrometry (LA-REIMS) in cervical cancer screening. FINDINGS: In a population of 130 women, LA-REIMS achieved 94% sensitivity and 83% specificity (AUC: 91.6%) in distinguishing women testing positive (n = 65) or negative (n = 65) for hrHPV. We performed further analysis according to disease severity with LA-REIMS achieving sensitivity and specificity of 91% and 73% respectively (AUC: 86.7%) in discriminating normal from high-grade pre-invasive disease. INTERPRETATION: This automated high-throughput technology holds promise as a low-cost and rapid test for cervical cancer screening and triage. The use of platforms like LA-REIMS has the potential to further improve the accuracy and efficiency of the current national screening programme. FUNDING: Work was funded by the MRC Imperial Confidence in Concept Scheme, Imperial College Healthcare Charity, British Society for Colposcopy and Cervical Pathology, National Research Development and Innovation Office of Hungary, Waters corporation and NIHR BRC.
BACKGROUND: The introduction of high-risk human papillomavirus (hrHPV) testing as part of primary cervical screening is anticipated to improve sensitivity, but also the number of women who will screen positive. Reflex cytology is the preferred triage test in most settings but has limitations including moderate diagnostic accuracy, lack of automation, inter-observer variability and the need for clinician-collected sample. Novel, objective and cost-effective approaches are needed. METHODS: In this study, we assessed the potential use of an automated metabolomic robotic platform, employing the principle of laser-assisted Rapid Evaporative Ionisation Mass Spectrometry (LA-REIMS) in cervical cancer screening. FINDINGS: In a population of 130 women, LA-REIMS achieved 94% sensitivity and 83% specificity (AUC: 91.6%) in distinguishing women testing positive (n = 65) or negative (n = 65) for hrHPV. We performed further analysis according to disease severity with LA-REIMS achieving sensitivity and specificity of 91% and 73% respectively (AUC: 86.7%) in discriminating normal from high-grade pre-invasive disease. INTERPRETATION: This automated high-throughput technology holds promise as a low-cost and rapid test for cervical cancer screening and triage. The use of platforms like LA-REIMS has the potential to further improve the accuracy and efficiency of the current national screening programme. FUNDING: Work was funded by the MRC Imperial Confidence in Concept Scheme, Imperial College Healthcare Charity, British Society for Colposcopy and Cervical Pathology, National Research Development and Innovation Office of Hungary, Waters corporation and NIHR BRC.
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