Clinical Performance Evaluation of Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
- Conditions
- Monkeypox infection status
- Registration Number
- DRKS00030899
- Lead Sponsor
- DaAn Gene Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1. Having at least one symptom of monkeypox at the time of sampling
2. Diagnostic result: (previous) diagnostic results will be used for the determination of the groups (positive, negative) in the study.
Exclusion Criteria
1. Insufficient sample amount
2. Insufficient sample quality: Samples that cannot be processed with the comparator and subject device
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)