Sensitivity of SARS-CoV-2 Rapid-Antigen-tests in vaccinated COVID-19 Patients: are negative test results misleading?

Sensitivity of SARS-CoV-2 Rapid-Antigen-tests in vaccinated COVID-19 Patients: are negative test results misleading? - COVID-19-Rapid-Antigen-test-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027348

Enrollment

300

Registered

2021-12-21

Start date

2021-12-09

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

Corona Virus Disease 19

Interventions

Group 1: Retrospective Study Design: Sensitivity of the rapid-antigen-test used in patients vaccinated against SARS-CoV-2. PCR positive patients with positive Rapid Antigen test

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Positive PCR-test on SARS-CoV-2, rapid-antigen-test was done and test result was recorded, immunisation status was recorded and is either unvaccinated or fully vaccinated, Patient is of legal age.

Exclusion criteria

Exclusion criteria: No positive PCR-test on SARS-CoV-2, rapid-antigen-test was not done or test result was not recorded, immunisation status was not recorded or initial immunization was not concluded, Patient is below legal age.

Design outcomes

Primary

Measure	Time frame
Sensitivity of the rapid-antigen-test used in Patients vaccinated against SARS-CoV-2 with SARS-CoV-2 infection.	—

Secondary

Measure	Time frame
Comparison between the sensitivity of rapid-antigen-test results in Patients vaccinated against SARS-CoV-2 and Patients unvaccinated against SARS-CoV-2.	—

Countries

Germany

Contacts

Public ContactMatthias Bollinger

Schwarzwald-Baar-Klinikum Villingen-Schwenningen, Villingen-Schwenningen, Deutschland

bollingermatthias@gmail.com00497721932630

Outcome results

None listed

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