COVID 19
Conditions
Interventions
Group 1: A COVID-19 rapid test will be performed by lay users and by healthcare protfessionals. The results of both tests will be compared.
Group 2: The results from arm 1 will be compared to the res
Sponsors
SD Biosensor INC
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: General inclusion criteria (for all study parts): • The participant provided signed written informed consent prior to any study-specific procedure AND Specific inclusion criteria: • Part I, A + Part II, B o SARS-CoV-2 positive patients AND o Symptomatic subjects are recruited within seven days after the onset of symptoms OR within seven days from the viral infection (e.g. contact with a SARS-CoV-2 positive patient) OR • Part I, B + Part II, A o Apparently healthy subjects AND o SARS-CoV-2 negative subjects • Part II, C o Subjects with unknown SARS-CoV-2 status, meaning that: - Subject was not diagnosed SARS-CoV-2 positive / negative within the last 60 days AND - Subject was not tested (e.g. self-test) for SARS-CoV-2 within the last 72 hours
Exclusion criteria
Exclusion criteria: General exclusion criteria: • The participant is unwilling or unable to provide an informed consent OR • Specimen type other than defined in the study protocol was collected (e.g. collection of oropharyngeal or throat samples) OR • High risk patients such as emergency patients suffering from life-threatening injuries / sickness OR • Subjects younger than 2 years Specific exclusion criteria: • Part I, B o Patients/Subjects that were diagnosed positive for SARS-CoV-2 within the last 60 days (according to RKI) • Part II o Healthcare professionals regularly performing swab sample collection • Part I, B + Part II, A o Patients/Subjects that had contact within the last 14 days to a person that has been diagnosed positive for SARS-CoV-2 OR o Patients/Subjects showing SARS-CoV-2 related symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I, ADiagnostic sensitivity > 80 % compared to the PCR-results Part I, BDiagnostic specificity > 98 % compared to the PCR-results Part II, B Diagnostic sensitivity > 80 % compared to the professional test result Part II, C Diagnostic specificity > 98 % compared to the professional test result Part II, A Result interpretationDetermination of the concordance of lay reading of contrived tests to the true result status of the respective pictures | — |
Secondary
| Measure | Time frame |
|---|---|
| Part I, A Diagnostic sensitivity Demonstration of the sensitivity in relation to different viral load ranges: • Ct = 25 • 25 30 | — |
Countries
Germany
Outcome results
None listed