Detection of Cytomegalovirus Virus in Neonates
Completed
- Conditions
- CMV
- Interventions
- Device: illumigene CMV assay, illumipro-10
- Registration Number
- NCT03251261
- Lead Sponsor
- Meridian Bioscience, Inc.
- Brief Summary
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1615
Inclusion Criteria
- Saliva swab specimens from neonates up to 21 days of age
- Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium.
- Flocked-nylon swabs
Exclusion Criteria
- Samples other than saliva swab from patients up to 21 days of age.
- Swabs other than flocked-nylon.
- Swabs in a viral transport media not defined in the Investigational Use Only package insert
- Multiple specimens from the same patient.
- Specimens received in the laboratory in unsatisfactory containers or condition.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Specimen collection illumigene CMV assay, illumipro-10 -
- Primary Outcome Measures
Name Time Method Qualitative detection of CMV to aid in the diagnosis of CMV within 30 days of sample collection Test each sample for CMV detection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
University of Utah
🇺🇸Salt Lake City, Utah, United States
British Columbia Children's Hospital / British Columbia Women's Hospital
🇨🇦Vancouver, British Coloumbia, Canada
Ospedale Sant'Orsola
🇮🇹Via Massarenti 19, Province Of Bologna, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia