Clinical Performance Study of Safety Test ABO Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-01-31

Brief Summary

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The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.

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Detailed Description

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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" \[2\], 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").

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 Safety Test ABO and ABTest Card® are already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.

Conditions

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Transfusion Reaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

In situ used for near patient In vitro Medical device.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Safety Test ABO and ABTest Card®

Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old for the category marked with \*.
* Undergo capillary blood sampling;
* Belong to one of the clinical category:

* 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 (eg. cancer), or undergoing haemodialysis\*;
* Patient with cold agglutinin\*;
* Premature patient with gestational age \< 37 weeks of newborn ≤27 days old in need of blood transfusion;
* Newborn eligible for Guthrie Test;
* Newborn eligible for glycemic test.
* Have health care insurance;
* Have given his/her written consent (or legal representative in case of newborn);

Exclusion Criteria

* Pregnant woman;
* Person deprived of liberty;
* Unconscious person;
* Person under guardianship or trusteeship;
* For neonatal clinical category: age ≥28 days and \<18 years old.

Eligible Sex

ALL

Accepts Healthy Volunteers

No