Detection of Cytomegalovirus Virus in Neonates (CMV)

Meridian Bioscience

Status: Completed

Conditions: CMV

Treatments: Device: illumigene CMV assay, illumipro-10

Study type: Observational

Funder types: Industry

Identifiers

NCT03251261

CLIN-DHF-333-001

Details and patient eligibility

About

To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs

Enrollment: 1,615 patients

Sex: All

Ages: Under 20 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,615 participants in 1 patient group

Specimen collection

Treatment:

Device: illumigene CMV assay, illumipro-10