Health TrialsbyHealthPanel

Clinical Performance Study of Safety Test ABO 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 Safety Test ABO with the ABTest Card 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

  • Safety Test ABO and ABTest Card®

    Diagnostic test

    Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

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: