Clinical Performance Study of Safety Test ABO Device

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

Study Overview

• Status: Not yet recruiting
• Conditions: Transfusion Reaction
• Intervention / Treatment: Diagnostic test: Safety Test ABO and ABTest Card®

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céline BOURIEZ; Phone Number: +33 (0) 3.20.96.53.86; Email: regulatory@diagast.com

Study Locations

• France
  • Montpellier, France
    • CHU Montpellier
    • Contact: Virginie TUNEZ
    • Principal Investigator: Virginie TUNEZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.	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).	5 minutes.
Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.	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).	5 minutes.
Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.	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).	5 minutes.
Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.	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).	5 minutes.
Blood compatibility between blood bag and patient for the Safety Test ABO.	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).	5 minutes.
Blood compatibility between blood bag and patient for the ABTest Card®.	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).	5 minutes.

Collaborators and Investigators

• Sponsor: Diagast
• Collaborators: Soladis

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: CPSP_23-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No