DxH520 Pediatric Reference Interval Verification

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Neonate: 0 to 30 days Infant: > 30 days to 2 years Child: 3 years to 12 years Adolescent: 13 years to 21 years

Official Title
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DxH520 Pediatric Reference Interval Verification

Conditions
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Healthy Subjects

Intervention / Treatment
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* Diagnostic Test: CBC/Diff Reference Interval


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CBC/Diff Reference Interval<br>Hematology routine diagnostic test | Diagnostic Test: CBC/Diff Reference Interval<br>* Results will not be used to manage patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Reference Interval Verification of Hematology CBC/Diff parameters | Verify Reference Intervals of Hematology CBC/Diff parameters in pediatric age groups. The blood cell count test parameters to be verified are: White Blood Cells (x10^3/µL), Red Blood Cells (x10^6/µL), Hemoglobin (g/dL), Hematocrit %, Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/dL), Mean Corpuscular Volume (fL), Red Cell Distribution Width-CV (%) Red cell Distribution Width-SD (fL), Platelets (x10^3/µL), Mean Platelet Volume (fL), Neutrophil %, Neutrophil Count (x10^3/µL), Lymphocyte %, Lymphocyte Count (x10^3/µL), Monocyte %, Monocyte Count (x10^3/µL), Eosinophil %, Eosinophil Count (x10^3/µL), Basophil %, Basophil Count (x10^3/µL). Study results will be analyzed following CLSI guideline EP28-A3c. | 1 day |