COVID-19
Conditions
Interventions
Group 1: Evaluation of the clinical performance of the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal (IP1) in line with the Regulation (EU) 2017/746.
In this clinical performance evaluation of IP1 for profe
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 I/II (A, B, C): • Subject and/or their legal representative has signed the study specific informed consent form AND Additional, subpart specific inclusion criteria: Part I, A and Part II, A: • Positive subject is recruited within seven days after the onset of symptoms (symptomatic patients) OR within seven days from contact with a SARS-CoV-2 positive person (asymptomatic patients) AND • Twenty of recruited positive patients plus dropouts (2 for study part I, 1 for study part II) will be asymptomatic
Exclusion criteria
Exclusion criteria: General exclusion criteria: - Subject is a high-risk patient suffering from life-threatening injuries/sickness OR - Subject is unable or unwilling to provide informed consent OR - Subject orally confirms that he/she has preexisting medical condition that previously caused a hypersensitivity OR - Subject is younger than 2 years old OR Additional, subpart specific exclusion criteria: Part I, B-C and Part II, B: - Subject has been confirmed positive for SARS-CoV-2 with a rapid antigen test or RT-PCR within last seven days Part II: - Subject has received a professional training in performing the antigen test (e.g., professionally collecting swab samples or performing rapid antigen tests) Part II, C: - Subject’s SARS-CoV-2 status is known (e.g., subject was tested for SARS-CoV-2 over the past 72 hours)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the IP1 (also applicable for IP2), there will be two primary endpoints: • Relative diagnostic sensitivity when compared to the RT-PCR (CP1) • Relative diagnostic specificity when compared to the RT-PCR (CP1) For IP2, there will be two primary endpoints: • Level of concordance of lay reading with the test’s true status • Level of concordance of lay self-testing results with the testing by professionals | — |
Secondary
| Measure | Time frame |
|---|---|
| For IP1 (also applicable for IP2), there will be secondary endpoints: • Diagnostic sensitivity in relation to different viral load ranges (if applicable depending on group sample sizes): o Ct = 20 o 20 35 • Descriptive presentation of all available test results for discrepant results (incl. 2nd RT-PCR test) | — |
Countries
Germany
Contacts
Public ContactMaria Vehreschild
Universitätsklinikum Frankfurt, Medizinische Klinik II, Infektiologie
Outcome results
None listed