Clinical Performance Study of the ABTest Card® Device.

Diagast

Status

Not yet enrolling

Conditions

Transfusion Reaction

Treatments

Diagnostic Test: ABTest Card®REF and ABTest Card®NEW

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06557031

CPSP_23-03

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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) ;