ABTEST© Card Clinical Perfomance Study

Diagast100 enrolled

Overview

The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

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) .

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Transfusion Reaction

Interventions

ABTEST cardDIAGNOSTIC_TEST

Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

CH Arras

Arras, France

Outcomes

Primary Outcomes

Agreement between two reagents

performance of pre transfusional controls with the referent reagent and the reagent in study

Time frame: 5 minutes

Data from ClinicalTrials.gov

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