Guidance

Appendix B: new technology supplier checklist

Updated 20 February 2024

This checklist outlines all the information commercial providers may need to submit with their application for a new human papillomavirus (HPV) test for use in cervical screening in the UK.

Please include all information for all relevant sections of the checklist and submit this with your application.

1. New technology

1. A brief description of the new technology and append product inserts.
2. State the potential application of the technology within the NHS Cervical Screening Programme (NHSCSP).
3. If the technology is CE marked or approved by an official body, please state what indications it is approved for.
4. If CE marking is currently being sought for the new technology, give the approximate timescale for its acquisition.
5. If the technology is FDA approved, please state what indications it is approved for.
6. If FDA approval is currently being sought for the new technology, give the approximate timescale for its acquisition.

2. HPV tests

1. State whether or not the technology stipulates an expiry date.
2. State what bio specimen-types or media the technology is validated for and provide full reports.
3. State whether or not the technology tests for high risk HPV types only and includes at least 13 high risk HPV types (16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68).
4. Describe the internal or endogenous control (if included within the technology).
5. State the throughput of the assay based on a 9am to 5pm working day and the operator ‘hands on’ time. Append a summary or overview of the timings of key processes and required interventions.
6. State whether or not the technology provides individual genotype results for other high risk HPV types and if so, state which types.
7. State whether or not the technology has an automated detection procedure.
8. Describe briefly, the read-out of the assay.
9. State whether or not samples will require pre-processing. If they do, state if there is a pre-analytic automated solution which has been validated by the manufacturer and whether it accommodates both media types used within the NHSCSP (Thinprep™ and, or Surepath™ (including new Surepath™ vials)).
10. State whether or not there is a tried middleware solution(s) that supports interface or download of results from the technology to laboratory information management systems.
11. State whether or not the technology has been evaluated against similar technologies currently used in the NHSCSP. If it has, provide full reports of key comparator data with respect to technical and clinical performance.
12. For HPV tests, state whether or not there is peer-reviewed data on performance relative to internationally accepted performance metrics such as those outlined in Meijer and others, 2009 and provide copies of those reports.
13. State whether or not the HPV test and technology are already in use for cervical screening and disease management. If they are, provide a summary of location and scale.
14. State whether or not the automated pre-processing or analytic method is already in use. If it is, provide a summary of location and scale.
15. State what are considered to be the advantages of this technology over those currently in use by the NHSCSP. If available, provide reports to support this summary or statement.

3. LBC systems

1. State whether or not the technology stipulates an expiry date.
2. State what bio specimen-types or media the technology is validated for and provide full reports.
3. State the throughput of the platform based on a 9am to 5pm working day and the operator ‘hands on’ time. Append a summary or overview of the timings of key processes and required interventions.
4. State whether or not the technology has been evaluated against similar technologies currently used in the NHSCSP. If it has, provide full reports of key comparator data with respect to technical and clinical performance.
5. State whether or not the technology has been evaluated with HPV tests currently used in the NHSCSP. If it has, please provide details and append full report.
6. State whether or not the technology is already in use for cervical screening and disease management. If it is, provide a summary of location/ scale.
7. State what are considered to be the advantages of this technology over those currently in use by the NHSCSP. If available, provide reports to support this summary or statement.