Health TrialsbyHealthPanel

Clinical Performance Study of the ABTest Card® Device.

ConditionTransfusion Reaction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDiagast

About this trial

The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old for the category marked with *.

Undergo capillary blood sampling ;

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)* ;

Disqualifiers

Pregnant woman ;

Person deprived of liberty ;

Unconscious person ;

Person under guardianship or trusteeship ;

Trial design

Design model

Single group

Treatments tested in this trial

  • ABTest Card®REF and ABTest Card®NEW

    Diagnostic test

    Pre transfusional control with the ABTest Card®REF device (predicate device) and the ABTest Card®NEW device (investigational device).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.

Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is concordance if the two "patient" blood types are identical.

Time frame
1 day.

Secondary outcomes

1

Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.

Comparison of the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is concordance if the two "donor" blood types are identical.

Time frame
1 day.
2

Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.

Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O). There is concordance if the two "patient" blood types are identical.

Time frame
1 day.
3

Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.

Comparison of the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O). There is concordance if the two "donor" blood types are identical.

Time frame
1 day.
4

Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.

Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O). There is blood compatibility if the two blood types follow specific associations.

Time frame
1 day.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diagast

Lead sponsor

Soladis

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: