Liquid-based cytology (LBC) has replaced conventional smears in the UK. The National Institute for Health and Clinical Excellence (NICE) recommended the use of LBC in 2003. ThinPrepTM (TP) and SurePathTM (SP) LBC systems were adopted for use in the National Health Service Cervical Screening Programme (NHSCSP) in the UK. NICE recommended further review of any other technologies or other liquid-based cytology systems in the future. For any second-generation LBC systems to be considered for cervical screening in the NHSCSP, there must be an evaluation of technical requirements and clinical data relating to their sensitivity, specificity and the percentage of inadequate samples.The objective of the work undertaken for this thesis was to provide evidence to enable an informed decision on the use of second-generation liquid-based cytology systems for cervical screening in the UK. The decision to accept the second-generation LBC system in the NHSCSP is based on its reliability, clinical effectiveness and cost implications. This work will determine the reliability, microscopic quality and reproducibility of slides of the second-generation LBC system, and the results of this work will form the platform for progression to the clinical evaluation of the system.Initially, four second-generation LBC systems were considered suitable for evaluation. They were Seroa CYTO-screen, Shandon Papspin, LGM Liqui-PREP and CellSolution 120. However, the specifications of only one system (CellSolution 120TM) met NHSCSP technical requirements to start the evaluation. One hundred random, electronically generated colposcopy patient samples were used to assess the technical reliability of the CellSolution 120TM system. The technical evaluation consisted of pre-phase I and phase I. The results of these phases will decide whether the CS 120TM liquid-based cytology system could be carried further for clinical evaluation (phase II) or not.This study was sponsored by the NHS Purchasing and Supply Agency (PASA), the Centre for Evidence based Purchasing (CEP) on behalf of the NHSCSP. The Manchester Cytology Centre (MCC) was selected as the site for evaluation of CellSolution 120™ and the project was managed by Guildford Medical Device Evaluation Centre (GMEC) on behalf of CEP.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:549046 |
| Date | January 2011 |
| Creators | Shah, Bijal Nigam |
| Contributors | Freemont, Anthony |
| Publisher | University of Manchester |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | https://www.research.manchester.ac.uk/portal/en/theses/evaluation-of-secondgeneration-liquidbased-cytology-system-for-the-detection-of-cervical-abnormality(329f87e8-d77c-480f-9145-93508e72d691).html |
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