ABTEST© Card Clinical Perfomance Study

Diagast

Status: Completed

Conditions: Transfusion Reaction

Treatments: Diagnostic Test: ABTEST card

Study type: Interventional

Funder types: Industry

Identifiers

NCT05140395

CPSP_20-01_V1

Details and patient eligibility

About

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

Full 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) .

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Pre transfusion control

Experimental group

Description:

Pre control transfusion with the referent reagent and the in study reagent

Treatment:

Diagnostic Test: ABTEST card