SARS-CoV-2 Infection Status
Conditions
Interventions
Group 1: Testing of samples (nasopharyngeal swab, oropharyngeal swab) with MAGLUMI SARS-CoV-2 Ag (CLIA) kit
Group 2: Testing of samples (nasopharyngeal swab, oropharyngeal swab) with the comparator de
Sponsors
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: more than 18 years old; 2. Probands 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; 3. Subject must be experiencing at least one symptom of COVID-19 for 7 days or fewer from study enrolment.
Exclusion criteria
Exclusion criteria: 1. less than 18 years old; 2. Vaccinated within the last 48h; 3. Ear, nose and throat (ENT) operation within the last six months and/or encephalocele; 4. Haemophilia and/or using anticoagulant drugs; 5. Pregnant or breast-feeding; 6. Lack of compliance or other justifications that precludes satisfactory participation in the study as judged by the investigator; 7. Inability to understand the nature of, extent of, and procedures required by the study as judged by the Investigator; 8. Being dependent of the sponsor/investigator; 9. Not enough sample amount
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to obtain diagnostic sensitivity (DSens, positive percentage agreement - PPA) and diagnostic specificity (DSpec, negative percentage agreement - NPA) data for the MAGLUMI® SARSCoV-2 Ag (CLIA) kit in comparison to a nucleic acid amplification test (NAAT)-based comparator device. The data will be used as a part of the performance evaluation and as a certification of the device according to IVDR and NMPA requirements. The primary endpoints of the study are diagnostic performance parameters of the device (sensitivity and specificity represented by PPA and NPA respectively) relative to the comparator device. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to obtain the positive predictive value (PPV), negative predictive value (NPV) and likelihood ratio (LR) in the diagnosis of SARS-CoV-2 infection. Secondary endpoints of the study are predictive values and likelihood ratios. | — |
Countries
Germany
Contacts
Public ContactHakan Inan
Requalite GmbH
Outcome results
None listed