Guidance

Cystic fibrosis: screening laboratory handbook

This document explains the guidelines for laboratories screening newborns for cystic fibrosis (CF) in the UK.

Documents

Details

The handbook sets out laboratory standards and guidelines for cystic fibrosis (CF) screening in newborn babies, covering:

  • the CF screening protocol
  • laboratory quality and performance
  • pre-analytical factors
  • the immunoreactive trypsinogen (IRT) assay
  • genetic analysis
  • reporting and communication of results
  • programme monitoring and data collection
  • the background to CF screening

The handbook also includes links to screening result template letters, follow up forms, and information for parents/carers.

This publication was previously published by Public Health England, which closed on 30 September 2021.

Updates to this page

Published 1 February 2014
Last updated 20 December 2024 + show all updates
  1. Updated the national cut-off values for the Genetic Screening Processor (GSP) analyser.

  2. Added clarification that publication was previously published by Public Health England. Removed screening helpdesk information.

  3. GSP figures in the standard protocol section of the lab handbook have been changed from 45 µg/L to 46 µg/L for cut-off A, and 55 µg/L to 56 µg/L for cut-off B. The accompanying flowchart (figure 1) has been updated to reflect these changes.

  4. Reviewed and updated guidance, replacing the 2014 version.

  5. First published.

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