Clinical Performance Evaluation of bioperfectus COVID-19 Coronavirus Real Time PCR Kits.
- Conditions
- SARS-CoV-2 Infection Status
- Registration Number
- DRKS00028977
- Lead Sponsor
- Jiangsu Bioperfectus Technologies Co, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 594
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive Percent Agreement (PPA) in lieu of Diagnostic sensitivity (DSens), Negative Percent Agreement (NPA) in lieu of Diagnostic specificity (DSpec)
- Secondary Outcome Measures
Name Time Method Positive predictive value (PPV), Negative predictive value (NPV), Likelihood ratio (LR)