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
- Conditions
- SARS-CoV-2 Infection Status
- Registration Number
- DRKS00025374
- Lead Sponsor
- MED TRUST Handelsges.m.b.H.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ser performance evaluation for tests A and B.