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Covid-19 Rapid Diagnostic Tests on Blood Drop

Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04467008
Acronym
COVID-TEST
Enrollment
113
Registered
2020-07-10
Start date
2020-07-15
Completion date
2020-08-15
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Covid 19, Diagnostic, Biosynex, Blood drop

Brief 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.

Interventions

None listed

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Positivity of the rapid diagnostic testImmediate, up to 1 day.Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026