The HPA Microbiology Services Division (MSD) has developed guidance on the development and validation of diagnostics that rely on nucleic acid amplification. The guidance has been developed to ensure that the HPA remains compliant with the evolving EU regulatory framework for the use of in-house tests in patient care pathways. The group of contributors included members of the HPA Molecular Diagnostic Forum (MDF), the Head of Quality and a group within reference microbiology at Colindale.
Although the main principles of the draft guidance have been endorsed by the HPA and the main recommendations are being implemented it is recognised that the document will require some re-drafting and improvement. Furthermore, although the process leading to the guidance has involved a broad group of interested parties it is recognised that further consultation would be extremely helpful.
What will happen to your comments?
All comments will be sent to the developers at the end of the consultation. The comments will be aggregated and dealt with. It is planned to produce a document detailing responses that will be available to interested parties.
Acknowledgement of comments
You will receive an acknowledgement when you email your comments.
Deadline for responses
9 December 2011
Address for responses
Anticipated publication date
It is planned that the final draft, as amended through consultation, will be released in January 2012. The final document will be issued as an HPA publication. The final document is also expected to include an additional annex giving guidance on the application of Westgard multirules to run QC in real-time PCR assays. The use of these QC procedures is effectively mandated by QSOP27 (a National Standard Method) but implementation has been patchy since confusion exists over how Westgard principles should be applied to molecular assays. A QC tool is being adapted to assist compliance with the guidance.
Laboratory Directors and Unit Heads at Colindale
Regional Microbiologists, Clinical Service Directors and Unit Heads in the regional laboratories
Directors of HPA and HPA Divisions
Directors of Reference Laboratories in the Devolved Administrations
Leads in NHS pathology laboratories
Last reviewed: 23 December 2011