Clinical Performance Study of Safety Test ABO Device

NCT06543771 | Not Yet Recruiting

• 1 other identifier: CPSP_23-07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transfusion Reaction

Outcome Measures

Primary Outcomes (6)

• 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.

Interventions

Safety Test ABO and ABTest Card® DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• Diagast: lead
• Soladis: collaborator

Study Sites (1)

CHU Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Central Study Contacts

Céline BOURIEZ

CONTACT

+33 (0) 3.20.96.53.86; regulatory@diagast.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In situ used for near patient In vitro Medical device.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-06

Locations

FR (1)