Clinical Performance Study of the ABTest Card® Device. (NCT06557031) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance Study of the ABTest Card® Device.
France200 participantsStarted 2024-09
Plain-language summary
The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old for the category marked with \*.
* Undergo capillary blood sampling ;
* Belong to one of the clinical categories:
* Patient in need of blood transfusion without any pathology known to have an impact on transfusion act\* ;
* Patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)\* ;
* Patient in need of blood transfusion suffering from haematology disease (e.g. cancer), or undergoing haemodialysis\* ;
* Patient with cold agglutinin\* ;
* Premature patient with gestational age \< 37 weeks or newborn ≤27 days old in need of blood transfusion ;
* Newborn eligible for the Guthrie Test ;
* Newborn eligible for the glycaemic test.
* Have health care insurance ;
* Have given his/her written consent (or legal representative in the case of a newborn) ;
Exclusion Criteria:
* Pregnant woman ;
* Person deprived of liberty ;
* Unconscious person ;
* Person under guardianship or trusteeship ;
* For paediatric clinical category: age ≥28 days and \<18 years old.
What they're measuring
1
Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.