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ABTEST© Card Clinical Perfomance Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT05140395

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

Lead sponsor: Diagast•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Diagast

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) .

Age

All ages

Sex

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 1, 2021Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment100

Start dateJun 2021

Last updatedDec 1, 2021

Condition

Transfusion Reaction

Locations shown

CH Arras

Arras

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2021Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions