NCT04467008

Covid-19 Rapid Diagnostic Tests on Blood Drop

Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

• Covid19

Timeline

• Start date: 2020-07-15
• Primary completion: 2020-08-15
• Completion: 2020-08-15
• First posted: 2020-07-10
• Last updated: 2020-11-10

Locations

1 site across 1 country: France