DxH520 Pediatric Reference Interval Verification

Beckman Coulter

Status: Completed

Conditions: Healthy Subjects

Treatments: Diagnostic Test: CBC/Diff Reference Interval

Study type: Observational

Funder types: Industry

Identifiers

NCT03243266

B90590

Details and patient eligibility

About

Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.

Full description

Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:

1. Neonate: 0 to 30 days
2. Infant: > 30 days to 2 years
3. Child: 3 years to 12 years
4. Adolescent: 13 years to 21 years

Enrollment: 290 patients

Sex: All

Ages: 1 minute to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All subject genders, race and ethnicity will be included in the study. Pediatric samples will be targeted for this study within the specified age ranges.
• Specimens should be from apparently healthy individuals.
• Samples from inpatient and ED visits maybe included if they are confirmed to be the final CBC before discharge and the patient had a non-hematological diagnosis

Exclusion criteria

• Samples originating from a hematology/oncology clinic (both inpatient and outpatient)
• Samples originating from a patient with a hematological disorder or diagnosis
• Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge

Trial design

290 participants in 1 patient group

CBC/Diff Reference Interval

Description:

Hematology routine diagnostic test

Treatment:

Diagnostic Test: CBC/Diff Reference Interval