Набор скоро начнётся NCT06557031

Clinical Performance Study of the ABTest Card® Device.

Без фазы С лечением Transfusion Reaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ABTest Card®REF and ABTest Card®NEW.
Кому может быть актуально: Состояния в реестре: Transfusion Reaction. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

Подробное описание

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.

Вмешательства

Диагностический тест 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).

Первичные конечные точки

Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results. [Срок оценки: 1 day.]

Вторичные конечные точки (5)

Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results. [Срок оценки: 1 day.]
Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF. [Срок оценки: 1 day.]
Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF. [Срок оценки: 1 day.]
Blood compatibility between the blood bag and the patient for the ABTest Card®NEW. [Срок оценки: 1 day.]
Blood compatibility between the blood bag and the patient for the ABTest Card®REF. [Срок оценки: 1 day.]

Критерии участия

Критерии включения

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) ;