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OpenTrials
Completed

NCT Number: NCT04467008

Covid-19 Rapid Diagnostic Tests on Blood Drop

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Disease Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, 92200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Positivity of the rapid diagnostic test

    Time frame: Immediate, up to 1 day.

    Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

Acronym: COVID-TEST

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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