ABTEST© Card Clinical Perfomance Study

Not Applicable

Completed

• Conditions: Transfusion Reaction

• 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) .

Study Timeline

• Study Start: 2021-06-06
• Primary Completion: 2021-10-28
• Status Verified: 2021-11
• Study Completion: 2021-11-04
• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Last Update Submitted: 2021-11-19
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

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

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

Trial Locations

Locations (1)

CH Arras; 🇫🇷 Arras, France