Clinical performance study of the STANDARD™ Q COVID-19 Ag Test and the STANDARD™ Q COVID-19 Ag Test 2.0
- Conditions
- covid-19
- Registration Number
- DRKS00031149
- Lead Sponsor
- SD Biosensor INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1100
General inclusion criteria for all study parts (A1/ A2, B1/ B2 and C1/ C2):
• Subject (and legally authorized representative, if applicable) has voluntarily provided signed written informed consent, for children assent might be sufficient, after having been informed of all aspects of the study that are relevant for the decision to participate and prior to any study-specific procedure AND
Additional study part-specific inclusion criteria:
• For study part A1/ A2:
o Subject has been previously confirmed positive for COVID-19 by a documented CE marked molecular test (within the last 24 hours) or professional antigen test (within the last 12 hours) AND
o SARS-CoV-2 positive subject is recruited within seven days after COVID-19 symptom onset OR in case of asymptomatic subjects within ten days after the first exposure to a confirmed COVID-19 case
• For study part B1/ B2:
o Subject has been previously confirmed negative for COVID-19 by a documented CE marked molecular test (within the last 24 hours) or professional antigen test (within the last 12 hours)
• For study part C1/ C2:
o Subject has been previously confirmed negative for COVID-19 by a documented CE marked molecular test (within the last 24 hours) or professional antigen test (within the last 12 hours) AND
o Subject is currently treated as an in-patient in a hospital
General exclusion criteria for all study parts (A1/ A2, B1/ B2 and C1/ C2):
• Subject is a high-risk patient such as emergency patients suffering from life-threatening injuries/ sickness OR
• Subject is unable or unwilling to provide informed consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint for IP1:<br>Calculation of the diagnostic sensitivity and diagnostic specificity of IP1 performed on nasal and nasopharyngeal samples, respectively, relative to the comparator product performed on the paired nasopharyngeal sample.<br><br>Primary endpoint for IP2:<br>Calculation of the diagnostic sensitivity and diagnostic specificity of IP2 performed on nasal and nasopharyngeal samples, respectively, relative to the comparator product performed on the paired nasopharyngeal sample.<br><br>Acceptance criteria for IP1 and IP2:<br>- Diagnostic sensitivity > 80 %<br>- diagnostic specificity > 98%
- Secondary Outcome Measures
Name Time Method Secondary endpoints for IP1 and IP2, respectively:<br>- Diagnostic sensitivity for different viral load ranges (Ct = 25; 25 < Ct = 30; Ct > 30) in dependence of the collected specimen types<br>- Diagnostic sensitivity relative to different days post symptom onset (= 3 days; 4- 5 days; 6- 7 days; only for symptomatic subjects) in dependance of the collected specimen type <br>- Diagnostic sensitivity and diagnostic specificity for all participating study sites in dependence of the collected specimen type<br>- Diagnostic specificity in hospitalized individuals in dependance of the collected specimen type