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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01346-51 | Other Identifier | ID-RCB |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| newborn screening for sickle cell disease | Newborns with a targeted neonatal screening for sickle cell disease carried out at the University Hospital of Lyon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCD newborn screening with the MS/MS method from Zentech | Other | The analysis of the SCD newborn screening with the MS/MS method from Zentech will be realized after achievement and biological validation of the SCD newborn screening in the usual care pathway. The results will be compared with the method used at the Lille Academic Hospital (CHU Lille) (sub-contractor for SCD newborn screening of Lyon) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent agreement between the two techniques | Non-inferiority (difference <1%) in terms of sensitivity and specificity between the results obtained with the MS/MS method and those obtained with the technique currently used at the Lille CHU (sub-contractor for SCD newborn screening of Lyon) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Infants with SCD newborn screening conducted in the hospital center of Lyon
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier Est - Hospices Civils de Lyon | Bron | 69677 | France | |||
| Hopital de la Croix Rousse |
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|
| Lyon |
| 69004, |
| France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D004194 | Disease |
| D012805 | Sickle Cell Trait |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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