The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).
CHU Montpellier
Montpellier, France
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 5 minutes.