Biocartis Clinical Performance Evaluation Study in Sierra Leone of the Biocartis Idylla System with the Rapid Ebola Virus Triage Test
Not Applicable
- Conditions
- Ebola
- Registration Number
- PACTR201501001002391
- Lead Sponsor
- Biocartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
¿Samples can be used for investigational purposes according to the applicable laws
¿Whole blood samples of patients with symptoms of Ebola infection
Exclusion criteria:
¿Patient objected to providing his/her sample to third parties for research purposes or samples not released for research purposes
Exclusion Criteria
Non Ebola , Non Suspect patient
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage positive and the negative agreemtn will be included in the calculation;Percentage overall agreement as defined by the percentage of valid Ebola Test results in agreement with the valid Ebola Reference results;Percentage of overall agreement at the first level i.e. with respect to the dichotomous level Ebola Virus detected or not detected and at the second level, i.e. with respect to the specific Ebola virus strain (Zaire or Sudan). Confidence interval on the diagnostic agreement will be used to evaluate the study acceptance criteria
- Secondary Outcome Measures
Name Time Method