Clinical trial NCT06543771: Clinical Performance Study of Safety Test ABO Device
Official title: Clinical Performance Study of Safety Test ABO Device
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transfusion Reaction
Lead sponsor: Diagast
Sponsor class: INDUSTRY
Collaborators: name: Soladis
First posted: 2024-08-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In situ used for near patient In vitro Medical device.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.
timeFrame: 5 minutes.
measure: Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.
timeFrame: 5 minutes.
measure: Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.
timeFrame: 5 minutes.
measure: Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.
timeFrame: 5 minutes.
measure: Blood compatibility between blood bag and patient for the Safety Test ABO.
timeFrame: 5 minutes.
measure: Blood compatibility between blood bag and patient for the ABTest Card®.
timeFrame: 5 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
References: