Transfusion Reaction
Conditions
Keywords
Reagent Kits, Diagnostic
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) .
Interventions
DIAGNOSTIC_TESTABTEST card
Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card
Sponsors
Diagast
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
in situ used for near patient In vitro Medical device
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (\<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not. 10 neonatal patients, background transfusion or Guthrie test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between two reagents | 5 minutes | performance of pre transfusional controls with the referent reagent and the reagent in study |
Countries
France
Outcome results
None listed