SiQHT19_Clinical performance study of the STANDARD™ i-Q COVID-19 Ag Home Test
- Conditions
- COVID 19
- Registration Number
- DRKS00029008
- Lead Sponsor
- SD Biosensor INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 431
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part I, ADiagnostic sensitivity > 80 % compared to the PCR-results<br>Part I, BDiagnostic specificity > 98 % compared to the PCR-results<br>Part II, B Diagnostic sensitivity > 80 % compared to the professional test result<br>Part II, C Diagnostic specificity > 98 % compared to the professional test result<br>Part II, A Result interpretationDetermination of the concordance of lay reading of contrived tests to the true result status of the respective pictures
- Secondary Outcome Measures
Name Time Method Part I, ADiagnostic sensitivity Demonstration of the sensitivity in relation to different viral load ranges:<br>• Ct = 25<br>• 25 < Ct = 30<br>• Ct > 30