Clinical Performance Study of the ABTest Card® Device.

NCT06557031 | Not Yet Recruiting

• 1 other identifier: CPSP_23-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.

Conditions

Transfusion Reaction

Outcome Measures

Primary Outcomes (1)

• Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.

  Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is concordance if the two "patient" blood types are identical.

  1 day.

Secondary Outcomes (5)

• Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.

  1 day.

• Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.

  1 day.

• Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.

  1 day.

• Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.

  1 day.

• Blood compatibility between the blood bag and the patient for the ABTest Card®REF.

  1 day.

Interventions

ABTest Card®REF and ABTest Card®NEW DIAGNOSTIC_TEST

Pre transfusional control with the ABTest Card®REF device (predicate device) and the ABTest Card®NEW device (investigational device).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old for the category marked with \*.
• Undergo capillary blood sampling ;
• Belong to one of the clinical categories:
• Patient in need of blood transfusion without any pathology known to have an impact on transfusion act\* ;
• Patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)\* ;
• Patient in need of blood transfusion suffering from haematology disease (e.g. cancer), or undergoing haemodialysis\* ;
• Patient with cold agglutinin\* ;
• Premature patient with gestational age \< 37 weeks or newborn ≤27 days old in need of blood transfusion ;
• Newborn eligible for the Guthrie Test ;
• Newborn eligible for the glycaemic test.
• Have health care insurance ;
• Have given his/her written consent (or legal representative in the case of a newborn) ;

You may not qualify if:

• Pregnant woman ;
• Person deprived of liberty ;
• Unconscious person ;
• Person under guardianship or trusteeship ;
• For paediatric clinical category: age ≥28 days and \<18 years old.

Sponsors & Collaborators

• Diagast: lead
• Soladis: collaborator

Study Sites (1)

CHU Orléans

Orléans, France

Location

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Central Study Contacts

Céline BOURIEZ

CONTACT

+33 (0) 3.20.96.53.86; regulatory@diagast.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In situ used for near patient In vitro Medical device.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

FR (1)