Clinical Performance Study of Safety Test ABO Device

Diagast

Status: Not yet enrolling

Conditions: Transfusion Reaction

Treatments: Diagnostic Test: Safety Test ABO and ABTest Card®

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06543771

CPSP_23-07

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 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 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)