Clinical Performance Study of the ABTest Card® Device.

Not Applicable

Not yet recruiting

• Conditions: Transfusion Reaction

• Registration Number: NCT06557031
• Lead Sponsor: Diagast

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.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Study Start: 2024-09
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.	1 day.	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.

Secondary Outcome Measures

Name	Time	Method
Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.	1 day.	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.
Blood compatibility between the blood bag and the patient for the ABTest Card®REF.	1 day.	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.
Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.	1 day.	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.
Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.	1 day.	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.
Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.	1 day.	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.

Trial Locations

Locations (1)

CHU Orléans; 🇫🇷 Orléans, France