Bilistick Point-of-care System 2.0 Bilirubin Validation Utilizing Blood Samples Collected in Pediatric Patients

Status: Completed
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (\<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 14 days
Healthy Volunteers: t
View:

• Participant is \<2-weeks of age

• Participant is inpatient hospital status

• Participant undergoing routine blood sample collection for total serum bilirubin

Locations
United States
Ohio
Kettering Health Main Campus
Kettering
Time Frame
Start Date: 2024-02-01
Completion Date: 2024-09-09
Participants
Target number of participants: 80
Treatments
Newborn
This study will include newborn pediatric patients under 2-weeks of age who are necessary to conduct this study and are representative of the target population for use with this device.
Sponsors
Leads: Kettering Health Network
Collaborators: Bilimetrix s.r.l.

This content was sourced from clinicaltrials.gov