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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBC/Diff Reference Interval | Hematology routine diagnostic test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBC/Diff Reference Interval | Diagnostic Test | Results will not be used to manage patients |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male, Female
Pediatric specimens from apparently healthy children
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| Name | Affiliation | Role |
|---|---|---|
| Khosrow Adeli, Ph.D | The Hospital for Sick Children | Principal Investigator |
| Meer-Taher Shabani-Rad, MD | Alberta Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T2N 2T9 | Canada | ||
| The Hospital for Sick Children |
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| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |