Detection of Cytomegalovirus Virus in Neonates

Illumigene CMV Clinical Trial Protocol

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

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.