Evaluation of the Sensitivity and Specificity of three Point of Care Tests (POCT) for Determination of SARS-Cov-2 (COVID-19), including a User Performance Evaluation for two devices

Evaluation of the Sensitivity and Specificity of three Point of Care Tests (POCT) for Determination of SARS-Cov-2 (COVID-19), including a User Performance Evaluation for two devices - MED-COV-001

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025374

Enrollment

400

Registered

2021-05-20

Start date

2021-05-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

SARS-CoV-2 Infection Status

Interventions

Group 1: Study participants perform three SARS-Cov-2 rapid tests themselves in test order A B C and a usability questionnaire for test A. Group 2: Study participants perform three SARS-Cov-2 rapid tes

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 – 80 years 2. Subjects who agree to the utilization of their samples in terms of sample processing, storage, analysis, documentation, optional shipment as required by the applied SARS-CoV-2 antigen tests and publication of study results.

Exclusion criteria

Exclusion criteria: 1. Lack of compliance or other justifications that precludes satisfactory participation in the study in the opinion of the Investigator. 2. Inability to understand the nature and the extent of the study and the procedures required. 3. Participation without legal capacity.

Design outcomes

Primary

Measure	Time frame
Test A, Test B, and Test C fulfill the Regulatory Requirements for Sensitivity, Specificity and Home use. Rapid Test results are referenced by RT-PCR (EURORealTime SARS-CoV-2 PCR Test Kit ).	—

Secondary

Measure	Time frame
User performance evaluation for tests A and B.	—

Countries

Germany

Contacts

Public ContactAndreas Pfützner

Pfützner Science & Health GmbH

andreas.pfuetzner@pfuetzner-mainz.com+49 6131 5884640

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026