Transfusion Reaction
Conditions
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.
Interventions
DIAGNOSTIC_TESTSafety Test ABO and ABTest Card®
Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).
Sponsors
Soladis
Diagast
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
In situ used for near patient In vitro Medical device.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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). |
Countries
France
Contacts
Primary ContactCéline BOURIEZ
Outcome results
None listed