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Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19

NCT04510454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-12-06

No results posted yet for this study

Summary

Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).

Conditions

Interventions

DIAGNOSTIC_TEST

Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR

Nasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Bénédicte MASTROIANNI, MD · Centre Léon Berard

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2021-06-24
Completion
2021-10-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04510454 on ClinicalTrials.gov