Clinical Performance Evaluation Study of the QuotientMosaiQ'M Treponema pallidum/CMV Screening Test-MosaiQ Serological Oisease Screening (SOS) Magazines EUStudy, Testing for Antibodies to Treponema pallidum andCytomegalovirus in Blood Oonors(EU; SDS MACH 1)
- Conditions
- Infectioues disease serology syphilisB25Cytomegaloviral disease
- Registration Number
- DRKS00017023
- Lead Sponsor
- Quotient Business Park Terre Bonne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 4826
Inclusion Criteria
Not applicable – Performance Evaluation Study for a single use microarray for serological disease screening
Exclusion Criteria
Not applicable – Performance Evaluation Study for a single use microarray for serological disease screening
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the MosaiQ Platform to CE marked instruments/assays currently on the market.<br>Instrument data will be entered into a central database using a printed copy of the instrument results - this will be the source document. Data will be entered on an excel spreadsheet - this will be the source document and subsequently entered into a central database. Site will be provided indepnedent laptops for data entry, and a USB sticks to remove data from the site and upload to the EDC system<br>The test results will be evaluated after finishing the tests.
- Secondary Outcome Measures
Name Time Method To evaluate the user performance of the microarray for each tested category on the MosaiQ Platform.