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Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
Published on: March 22, 2022
Initial performance evaluation of the UniCel® DxH 800 Coulter® cellular analysis system
B D Hedley1, M Keeney, I Chin-Yee
1Department of Hematology, London Health Sciences Centre, London, Ontario, Canada.
International Journal of Laboratory Hematology
|May 25, 2010
Summary
The Beckman Coulter UniCel® DxH 800 hematology analyzer accurately enumerates white blood cells (WBC), nucleated red blood cells (NRBC), and platelets (PLT). It shows improved performance over the Coulter® LH 780, especially in detecting NRBCs and handling interfering substances.
Area of Science:
- Hematology
- Clinical Chemistry
- Medical Instrumentation
Background:
- The Beckman Coulter UniCel® DxH 800 is a new hematology analyzer.
- Previous analyzers had limitations in accuracy and flagging efficiency.
Purpose of the Study:
- To evaluate the performance of the UniCel® DxH 800 hematology analyzer.
- To compare its accuracy in enumerating WBC, NRBC, and PLT against a predicate analyzer (Coulter® LH 780) and flow cytometry (FCM).
- To assess performance with interfering particles and extreme leukocytosis.
Main Methods:
- A set of 272 patient samples (normal and abnormal) was analyzed.
- Correlation studies were performed comparing DxH 800 results with Coulter® LH 780 and FCM reference methods.
- Samples with morphologically confirmed interference and extreme leukocytosis were specifically evaluated.
Main Results:
- High correlation coefficients (r² values) were observed for WBC (0.994), PLT (0.985), and NRBC (0.910) when compared to FCM.
- The DxH 800 demonstrated accurate WBC counts despite interfering particles.
- Accurate PLT and NRBC counts were achieved in low ranges, with reduced NRBC flagging rates and improved sensitivity/specificity compared to the LH 780.
Conclusions:
- The UniCel® DxH 800 shows significant improvement over previous impedance analyzers, particularly in NRBC detection (>1/100 WBC).
- It provides accurate WBC and PLT counts even with interfering substances.
- The analyzer offers improved NRBC flagging efficiency and accuracy compared to the Coulter® LH 780, with appropriate RBC parameter correction for extreme leukocytosis.
