Detection of Cytomegalovirus Virus in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1615 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-02

Study Completion Date

2018-03-05

Brief Summary

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

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Detailed Description

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Conditions

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CMV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Specimen collection

illumigene CMV assay, illumipro-10

Intervention Type DEVICE

CMV assay for detection of CMV

Interventions

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illumigene CMV assay, illumipro-10

CMV assay for detection of CMV

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

20 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes