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Completed

NCT Number: NCT05140395

ABTEST© Card Clinical Perfomance Study

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

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Key information

Conditions

Transfusion Reaction Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Arras

Arras, France

About this study

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) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABTEST card

Diagnostic Test

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

Primary outcomes

  1. Agreement between two reagents

    Time frame: 5 minutes

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

Sponsors and collaborators

Lead sponsor

Diagast

Industry

Registry information

Official study title

Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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