Clinical trial NCT06557031: Clinical Performance Study of the ABTest Card® Device.
Official title: Clinical Performance Study of the ABTest Card® Device.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transfusion Reaction
Lead sponsor: Diagast
Sponsor class: INDUSTRY
Collaborators: name: Soladis
First posted: 2024-08-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In situ used for near patient In vitro Medical device.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.
timeFrame: 1 day.
Secondary outcomes:
measure: Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.
timeFrame: 1 day.
measure: Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.
timeFrame: 1 day.
measure: Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.
timeFrame: 1 day.
measure: Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.
timeFrame: 1 day.
measure: Blood compatibility between the blood bag and the patient for the ABTest Card®REF.
timeFrame: 1 day.
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHU Orléans
Study officials:
References: