Trials / Completed
CompletedNCT05140395
ABTEST© Card Clinical Perfomance Study
Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Diagast · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution
Detailed description
The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ABTEST card | Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card |
Timeline
- Start date
- 2021-06-06
- Primary completion
- 2021-10-28
- Completion
- 2021-11-04
- First posted
- 2021-12-01
- Last updated
- 2021-12-01
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05140395. Inclusion in this directory is not an endorsement.