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Covid-19 Rapid Diagnostic Tests on Blood Drop

NCT ID: NCT04467008

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2020-08-15

Brief Summary

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This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

Detailed Description

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The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours.

Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).

As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.

Conditions

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Covid19

Keywords

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Covid 19 Diagnostic Biosynex Blood drop

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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One group of patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Confirmed COVID-19 diagnosis with at least one positive RT-PCR

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lee Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

CMC Ambroise Paré

Locations

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CMC Ambroise Paré

Neuilly-sur-Seine, , France

Site Status

Countries

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France

Other Identifiers

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2020/05

Identifier Type: -

Identifier Source: org_study_id