Clinical Performance Study of Safety Test ABO Device

Not Applicable

Not yet recruiting

• Conditions: Transfusion Reaction

• Registration Number: NCT06543771
• Lead Sponsor: Diagast

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-09
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.	5 minutes.	Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O).
Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.	5 minutes.	Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.	5 minutes.	Comparison of the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O).
Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.	5 minutes.	Comparison of the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Blood compatibility between blood bag and patient for the Safety Test ABO.	5 minutes.	Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Blood compatibility between blood bag and patient for the ABTest Card®.	5 minutes.	Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O).

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France