Detection of Cytomegalovirus Virus in Neonates

N/ACompletedNCT03251261

Meridian Bioscience, Inc.1,615 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,615

Conditions

CMV

Interventions

illumigene CMV assay, illumipro-10DEVICE

CMV assay for detection of CMV

Eligibility

Sex: ALLMax age: 20 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Utah

Salt Lake City, Utah, United States

The Prince of Wales Hospital

Randwick, New South Wales, Australia

British Columbia Children's Hospital / British Columbia Women's Hospital

Vancouver, British Coloumbia, Canada

Outcomes

Primary Outcomes

Qualitative detection of CMV to aid in the diagnosis of CMV

Test each sample for CMV detection

Time frame: within 30 days of sample collection

Data from ClinicalTrials.gov

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