DxH520 Pediatric Reference Interval Verification



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 21
Updated:1/26/2018
Start Date:June 19, 2017
End Date:March 2018
Contact:Astrid C Smit, MS
Email:acsmit@beckman.com
Phone:305-380-2582

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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.

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

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
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Calgary, Alberta
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