UK Standards for Microbiology Investigations - Guidance on the Development and Validation of Diagnostic Tests for Nucleic Acid Amplification and Detection

Oct 5, 2026

Uploaded by Himbo

UK Standards for Microbiology Investigations (SMIs) outline guidance for diagnostic test development and validation focused on nucleic acid amplification and detection. The document describes how SMIs are created, reviewed, and updated through consultation with UK health bodies and professional organisations, and explains intended user groups including clinicians, laboratory professionals, and healthcare service commissioners. It also frames SMIs within the full investigative workflow, from pre-analytical clinical syndrome assessment to analytical testing and post-analytical result reporting, supported by quality assurance principles and standardisation goals.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages49

Reading Time2 h 3 min

AccessFree to download

UK Standards for Microbiology Investigations

Guidance on diagnostic test development and validation

Acknowledgments and contributors

Intended users of SMIs

Background to SMIs and investigative workflow

Involvement of professional organisations

Quality assurance and certification

UK Standards for Microbiology Investigations Guidance on the Development and Validation of Diagnostic Tests that Depend on Nucleic Acid Amplification and Detection Acknowledgments UK Standards for Microbiology Investigations (SMIs) are developed under the auspices of the Health Protection Agency (HPA) working in partnership with the National Health Service (NHS), Public Health Wales and with the professional organisations whose logos are displayed below and listed on the website [http://www.hpa.org.uk/SMI/Partnerships](http://www.hpa.org.uk/SMI/Partnerships. SMIs)[. SMIs](http://www.hpa.org.uk/SMI/Partnerships. SMIs) are developed, reviewed and revised by various working groups which are overseen by a steering committee (see [http://www.hpa.org.uk/SMI/WorkingGroups](http://www.hpa.org.uk/SMI/WorkingGroups)). The contributions of many individuals in clinical, specialist and reference laboratories who have provided information and comments during the development of this document are acknowledged. We are grateful to the Medical Editors for editing the medical content. We also acknowledge Professor Nick Saunders for his considerable specialist input. For further information please contact us at: Standards Unit Microbiology Services Division Health Protection Agency 61 Colindale Avenue London NW9 5EQ E-mail: [standards@hpa.org.uk](standards@hpa.org.uk) Website: [http://www.hpa.org.uk/SMI](http://www.hpa.org.uk/SMI) UK Standards for Microbiology Investigations are produced in association with: UK Standards for Microbiology Investigations \# : Status Users of SMIs Three groups of users have been identified for whom SMIs are especially relevant: • SMIs are primarily intended as a general resource for practising professionals in the field operating in the field of laboratory medicine in the UK. Specialist advice should be obtained where necessary. • SMIs provide clinicians with information about the standard of laboratory services they should expect for the investigation of infection in their patients and the documents provide information that aids the electronic ordering of appropriate tests from hospital wards. • SMIs also provide commissioners of healthcare services with the standard of microbiology investigations they should be seeking as part of the clinical and public health care package for their population. Background to SMIs SMIs comprise a collection of recommended algorithms and procedures covering all stages of the investigative process in microbiology from the pre-analytical (clinical syndrome) stage to the analytical (laboratory testing) and post analytical (result interpretation and reporting) stages. Syndromic algorithms are supported by more detailed documents containing advice on the investigation of specific diseases and infections. Guidance notes cover the clinical background, differential diagnosis, and appropriate investigation of particular clinical conditions. Quality guidance notes describe essential laboratory methodologies which underpin quality, for example assay validation, quality assurance, and understanding uncertainty of measurement. Standardisation of the diagnostic process through the application of SMIs helps to assure the equivalence of investigation strategies in different laboratories across the UK and is essential for public health interventions, surveillance, and research and development activities. SMIs align advice on testing strategies with the UK diagnostic and public health agendas. Involvement of Professional Organisations The development of SMIs is undertaken within the HPA in partnership with the NHS, Public Health Wales and with professional organisations. The list of participating organisations may be found at [http://www.hpa.org.uk/SMI/Partnerships](http://www.hpa.org.uk/SMI/Partnerships. Inclusion)[. Inclusion](http://www.hpa.org.uk/SMI/Partnerships. Inclusion) of an organisation’s logo in an SMI implies support for the objectives and p

FAQs

What do UK Standards for Microbiology Investigations (SMIs) cover?

SMIs provide recommended algorithms and procedures covering the full microbiology investigative process, from pre-analytical stages to analytical testing and post-analytical interpretation and reporting.

Who are the primary intended users of SMIs?

SMIs are aimed at practising laboratory medicine professionals, clinicians who need expected laboratory service standards, and commissioners seeking appropriate microbiology investigation standards for healthcare packages.

How are SMIs developed and kept current?

SMIs are developed, reviewed, and revised by working groups overseen by a steering committee, with contributions from laboratories and input from professional organisations; the resulting guidance reflects the majority view of contributors.

Oct 5, 2026

Uploaded by Himbo