An interventional study of Safety Test ABO and ABTest Card® in Transfusion Reaction, sponsored by Diagast. Not yet recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Diagast · Not applicable, Interventional, and Other
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.
50 studies on the registry are indexed under Transfusion Reaction; 11 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 20 interventional studies indexed under Transfusion Reaction.
Browse Transfusion Reaction studies →Diagast is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Belong to one of the clinical category:
Exclusion Criteria:
Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).
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).
Time frame: 5 minutes.
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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