Introduction: The DxH 520 is a small hematology analyzer capable of performing CBC and 5-part differential in fresh whole blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants. Medical care of children and adolescents is significantly dependent on reference intervals to properly interpret laboratory test results. A multi-center study was performed to verify or establish pediatric reference intervals for all parameters (White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red Cell Distribution Width (RDW), RDW-SD, Platelets (PLT), Mean Platelet Volume (MPV), (Lymphocyte) LY%, LY#, Monocyte% (MO%), MO#, Neutrophil % (NE%), NE#, Eosinophil% (EO%), EO#, Basophil % (BA%), and BA#) with combined genders.

Methods: Whole blood samples from healthy children were tested within 8 hours of collection on the DxH 520 analyzer. Samples generating review flags or suspect messages were excluded from the analyses. Even gender distribution was targeted. A total of 208 specimens were enrolled that included 20 neonates (0 to 30 days), 27 infants (31 days to 2 years), 94 children (3 to 12 years) and 67 adolescents (13 to 21 years). Results were analyzed according to CLSI EP20-A3c guidelines.

Results: Reference intervals for the neonate age group were verified from existing published ranges using the transference method described in the guideline (Table 1). The robust method was used to calculate two sets of reference intervals partitioned by combining data from the infant and children age groups, and from the adolescent age group (Table 2).

Conclusion: Reference Intervals for CBC and differential parameters have been established for pediatric age groups (0 to 30 days, 31days to 12 years, 13 to 21 years) on the DxH 520 Hematology analyzer.

*CE marked. Pending 510(k) clearance by the United States Food and Drug Administration; not yet available for in vitro diagnostic use in the U.S.

Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

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Disclosures

Smit:Beckman Coulter: Employment. Seidel:Beckman Coulter: Employment. Rohrbach:Beckman Coulter: Employment. Magari:Beckman Coulter: Employment. Lo:Beckman Coulter: Employment. Martin:Beckman Coulter: Employment. Tejidor:Beckman Coulter: Employment.

Topics:
anticoagulants, complete blood count, edetate disodium, edetic acid, hemoglobin, in vitro diagnostics, laboratory test finding, mean corpuscular hemoglobin concentration determination, mean corpuscular volume analyses, mean platelet volume

Author notes

*

Asterisk with author names denotes non-ASH members.

© 2018 by The American Society of Hematology
2018
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