Clinical Performance Study of the ABTest Card® Device.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Transfusion Reaction
• Intervention / Treatment: Diagnostic test: ABTest Card®REF and ABTest Card®NEW

Detailed Description

Following some changes in the ABTest Card® raw materials, a new validation of the associated clinical performances is required. Raw materials of the ABTest Card® are : Triton, Cleanis, Tween, Yellow, Blue dye and the blood segment opener device.

According to the regulatory text "Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council", 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside").

The Regulation 2017/746 (IVDR) on IVDMD, has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the ABTest Card® is already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.

The purpose of this study is to document and verify the clinical performance of the ABTest Card® device in combination with the new raw materials used for manufacturing (ABTest Card®NEW), by comparing the results obtained with the ABTest Card®REF, already commercialised and used routinely by the study sites.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céline BOURIEZ; Phone Number: +33 (0) 3.20.96.53.86; Email: regulatory@diagast.com

Study Locations

• France
  • Orléans, France
    • CHU Orléans
    • Contact: Silvana LEO-KODELI
    • Principal Investigator: Silvana LEO-KODELI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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) ;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.	Comparison of the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is concordance if the two "donor" blood types are identical.	1 day.
Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.	Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O). There is concordance if the two "patient" blood types are identical.	1 day.
Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.	Comparison of the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O). There is concordance if the two "donor" blood types are identical.	1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.	Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O). There is blood compatibility if the two blood types follow specific associations.	1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®REF.	Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is blood compatibility if the two blood types follow specific associations.	1 day.

Collaborators and Investigators

• Sponsor: Diagast
• Collaborators: Soladis

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: CPSP_23-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No