CMV
Conditions
Brief summary
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs
Interventions
DEVICEillumigene CMV assay, illumipro-10
CMV assay for detection of CMV
Sponsors
Meridian Bioscience, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 20 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative detection of CMV to aid in the diagnosis of CMV | within 30 days of sample collection | Test each sample for CMV detection |
Countries
Australia, Canada, Italy, United States
Outcome results
None listed