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.
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
Last updated
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20 December 2024 Updated the national cut-off values for the Genetic Screening Processor (GSP) analyser.
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8 October 2024 Added clarification that publication was previously published by Public Health England. Removed screening helpdesk information.
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31 May 2022 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.
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18 August 2021 Reviewed and updated guidance, replacing the 2014 version.
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1 February 2014 First published.
Update history
2026-01-05 14:12
Updated cut off for GSP equipment users
2024-12-20 15:28
Updated the national cut-off values for the Genetic Screening Processor (GSP) analyser.
2024-10-08 15:54
Added clarification that publication was previously published by Public Health England. Removed screening helpdesk information.
2022-05-31 10:17
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.