Clinical Performance Evaluation of MAGLUMI® SARS-CoV-2 Ag (CLIA) kit (for diagnostic of COVID-19)
- Conditions
- SARS-CoV-2 Infection Status
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 259
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.
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>and NMPA requirements.<br>The primary endpoints of the study are<br>diagnostic performance parameters of the device (sensitivity and specificity represented by PPA and NPA respectively) relative to the comparator device.
- Secondary Outcome Measures
Name Time Method 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.<br>Secondary endpoints of the study are predictive values and likelihood ratios.