Clinical Performance Study of the ABTest Card® Device.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABTest Card®REF and ABTest Card®NEW.
- Who it may be relevant to
- Registry conditions: Transfusion Reaction. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test ABTest Card®REF and ABTest Card®NEW
Pre transfusional control with the ABTest Card®REF device (predicate device) and the ABTest Card®NEW device (investigational device).
Primary outcome measures
- Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results. [Time frame: 1 day.]
Secondary outcome measures (5)
- Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results. [Time frame: 1 day.]
- Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF. [Time frame: 1 day.]
- Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF. [Time frame: 1 day.]
- Blood compatibility between the blood bag and the patient for the ABTest Card®NEW. [Time frame: 1 day.]
- Blood compatibility between the blood bag and the patient for the ABTest Card®REF. [Time frame: 1 day.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Orléans — Orléans
Identifiers
NCT: NCT06557031 · CPSP_23-03