Clinical performance study of SARS-CoV-2 Antigen Self Test Nasal & SARS-CoV-2 Rapid Antigen Test 2.0 Nasal
- Conditions
- COVID-19
- Registration Number
- DRKS00031144
- Lead Sponsor
- SD Biosensor INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 452
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
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)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For the IP1 (also applicable for IP2), there will be two primary endpoints:<br>• Relative diagnostic sensitivity when compared to the RT-PCR (CP1) <br>• Relative diagnostic specificity when compared to the RT-PCR (CP1) <br>For IP2, there will be two primary endpoints:<br>• Level of concordance of lay reading with the test’s true status <br>• Level of concordance of lay self-testing results with the testing by professionals<br>
- Secondary Outcome Measures
Name Time Method For IP1 (also applicable for IP2), there will be secondary endpoints:<br>• Diagnostic sensitivity in relation to different viral load ranges (if applicable depending on group sample sizes):<br>o Ct = 20<br>o 20 < Ct = 25<br>o 25 < Ct = 30<br>o 30 < Ct = 35<br>o Ct >35 <br>• Descriptive presentation of all available test results for discrepant results (incl. 2nd RT-PCR test)