Diagnostic accuracy and feasibility of a rapid SARS-CoV-2 (COVID-19) antigen test in general practice – a prospective multicenter validation and implementation study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023822

Enrollment

4600

Registered

2020-12-21

Start date

2020-12-16

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

COVID-19 SARS-CoV-19 infection U07.1

Interventions

Group 1: Nearly simultaneous testing for SARS-CoV-2 by PCR Test and rapid antigen Test.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - respiratory symptoms (e.g. acute bronchitis or pneumonia, respiratory distress or fever) - Acute hypo- or anosmia or hypo- or ageusia

Exclusion criteria

Exclusion criteria: symptomatic and asymptomatic patients in a nursing home, asymptomatic patients whose testing is done for follow-up reasons (travel history, contact person, etc.)

Design outcomes

Primary

Measure	Time frame
-Validation of sensitivity, specificity, positive predictive value, negative predictive value of a rapid SARS-CoV-2 antigen tests in daily clinical routine	—

Countries

Germany

Contacts

Public ContactJörn Rohde

Universitätsklinikum Würzburg Institut für Allgemeinmedizin

rohde_j@ukw.de015118513320

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026