Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active DRKS00021220

Evaluation of the performance of novel rapid diagnostics for SARS-CoV-2 at point-of-care

Purpose / Objectives

Primary Outcome

To determine the diagnostic accuracy of COVID-19 antigen tests on a respiratory specimen (NP swab, OP swab), vs gold-standard real-time reverse-transcription PCR (RT-PCR), as performed in an affiliated reference laboratory on a respiratory specimen.

Diagnosis

  • COVID-19 infection

Target population

Inclusion criteria

  • Patients with suspected SARS-CoV-2 infection, age >18
  • Participants included will meet testing criteria as determined by the Department of Public Health.

 

Study design

  • Prospective

Intervention

This is a prospective study for diagnostic accuracy. The different test will be evaluated in substudies.

The same study design will be applied to each test evaluation (substudy) performed under this protocol.

Each substudy is a separate diagnostic accuracy study, with the primary objective of validating the performance of a novel rapid POC SARS-CoV-2 test in patients with suspected COVID-19 presenting to be tested at the testing sites.

We will enroll at least 500 participants and a maximum of 2,000 participants suspected to have COVID-19 at all sites per each substudy. At least 2,000 participants with a maximum of 5,000 participants in total.

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Responsibilities in overall study

Sponsor

Ruprecht-Karls-Universität Heidelberg

(National) Coordinating Investigator

Dr. med. Claudia Denkinger