SARS-CoV-2 Infection Status
Conditions
Interventions
Group 1: Each sample will be tested with the test device and the comparator method.
Sponsors
Sansure Biotech Inc.
Eligibility
Sex/Gender
All
Age
7 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: = 18: Able to sign the informed consent form (ICF) independently. 2. Age: =7 years and <18 years; Signing the consent form (ICF) by first degree relative upon consent of the minor patient. 3. Participants 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 4. Subject must be presenting with 1 or more of the signs and symptoms of a respiratory infection. Experiencing at least one symptom of COVID-19 for 3 days or fewer from study enrolment (as far as possible).
Exclusion criteria
Exclusion criteria: 1. Vaccinated against COVID-19 within the last 48 hours 2. Ear, nose and throat (ENT) surgery within the last six months and/or encephalocele 3. Haemophilia and/or using anticoagulant drugs 4. Lack of compliance or other reasons that precludes satisfactory participation in the study as judged by the Investigator 5. Inability to understand the nature of, extent of, and procedures required by the study as judged by the Investigator 6. Participants who are dependent of the sponsor/investigator in any way.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to obtain diagnostic sensitivity (DSens, represented by the positive percentage agreement - PPA) and diagnostic specificity (DSpec, represented by negative percentage agreement - NPA) data for the Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) in comparison to a comparator device. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to obtain the positive predictive value (PPV), negative predictive value (NPV) Likelihood ratio (LR) and diagnostic accuracy. | — |
Countries
Germany
Contacts
Public ContactHakan Inan
Requalite GmbH
Outcome results
None listed