SARS-CoV-2 Infection Status
Conditions
Interventions
Group 1: Samples (nasopharyngeal swab, oropharyngeal swab, sputum) will be taken by professional health care personnel for testing device A (COVID-19 Coronavirus (ORF1ab/N/E) Real Time PCR Kit) for co
Sponsors
Jiangsu Bioperfectus Technologies Co, Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years 2. Subjects who agree to the utilization of their samples for processing, storage, analysis, documentation, optional shipment as required by the applied SARS-CoV-2 test and publication of study results in anonymized manner
Exclusion criteria
Exclusion criteria: 1. Lack of compliance or other justifications that precludes satisfactory participation in the study as judged by the Investigator. 2. Inability to understand the nature of, extent of, and procedures required by the study. 3. Pregnancy/Brestfeeding 4. Recent ENT operation and/or encephalocele 5. Hemophilia and/or using anticoagulant drugs 6. Participants without legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive Percent Agreement (PPA) in lieu of Diagnostic sensitivity (DSens), Negative Percent Agreement (NPA) in lieu of Diagnostic specificity (DSpec) | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value (PPV), Negative predictive value (NPV), Likelihood ratio (LR) | — |
Countries
Germany
Contacts
Public ContactAndreas Pfützner
Pfützner Science & Health GmbH
Outcome results
None listed