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COVAG - Covid-19 Antigen Study - the Diagnostic Efficacy of SARS-CoV-2 Rapid Detection Tests

NCT05074017 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2222

Last updated 2021-10-20

No results posted yet for this study

Summary

The aim of the COVAG study (Covid-19 Antigen study) is to assess the diagnostic efficacy of two of the most used rapid antigen tests (Roche \& Abbott).

The study will be performed at the Corona Test Center Stuttgart Cannstatter Wasen. Approximately 2000 patients will be enrolled after having signed the Informed Consent Form (ICF). Each patient will receive 3 nasopharyngeal swabs. Two for the rapid antigen tests from Roche and Abbott and one for the RT-PCR. Furthermore an anamnesis, short clinical examination and blood draw is done. The blood is examined for SARS-CoV-2 antibodies and basic laboratory tests to be communicated to participants.

Conditions

  • COVID-19
  • SARS-CoV2 Infection
  • SARS (Disease)

Interventions

DEVICE

3 nasopharyngeal swab

3 nasopharyngeal swabs to conduct 2 rapid antigen tests for SARS-CoV-2 and a RT-PCR

Sponsors & Collaborators

  • Synlab Holding Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Winfried März, Prof. Dr. med · Synlab Holding Deutschland GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

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 NCT05074017 on ClinicalTrials.gov