covid-19
Conditions
Interventions
Group 1: The clinical study includes the performance of SARS-CoV-2 rapid antigen tests and RT-qPCR tests with samples from the nasal vestibule (nasal samples) and the posterior nasopharyngeal section
Sponsors
SD Biosensor INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint for IP1: 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. Primary endpoint for IP2: 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. Acceptance criteria for IP1 and IP2: - Diagnostic sensitivity > 80 % - diagnostic specificity > 98% | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints for IP1 and IP2, respectively: - Diagnostic sensitivity for different viral load ranges (Ct = 25; 25 30) in dependence of the collected specimen types - 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 - Diagnostic sensitivity and diagnostic specificity for all participating study sites in dependence of the collected specimen type - Diagnostic specificity in hospitalized individuals in dependance of the collected specimen type | — |
Countries
Germany
Contacts
Public ContactCharlotte von Engelhardt
Klinische Forschung Schwerin GmbH
Outcome results
None listed