ABTEST© Card Clinical Perfomance Study
Not Applicable
Completed
- Conditions
- Transfusion Reaction
- Interventions
- Diagnostic Test: ABTEST card
- Registration Number
- NCT05140395
- Lead Sponsor
- Diagast
- Brief Summary
The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution
- Detailed Description
The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre transfusion control ABTEST card Pre control transfusion with the referent reagent and the in study reagent
- Primary Outcome Measures
Name Time Method Agreement between two reagents 5 minutes performance of pre transfusional controls with the referent reagent and the reagent in study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CH Arras
🇫🇷Arras, France