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Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only. Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, France
Hopital de la Croix Rousse
Lyon, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Start Date
March 16, 2021
Primary Completion Date
December 10, 2022
Completion Date
December 10, 2022
Last Updated
April 17, 2024
1,431
ACTUAL participants
SCD newborn screening with the MS/MS method from Zentech
OTHER
Lead Sponsor
Hospices Civils de Lyon
NCT05170412
NCT06526117
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06665997