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The HemoScreen, a novel haematology analyser for the point of care
  1. Yaara Ben-Yosef1,
  2. Barak Marom1,
  3. Galit Hirshberg1,
  4. Carol D'Souza2,
  5. Anders Larsson3,
  6. Avishay Bransky1
  1. 1PixCell Medical Technologies Ltd., Yokneam Ilit, Israel
  2. 2Biomedical Sciences, Faculty of Science & Technology, University of Westminster, London, UK
  3. 3Department of Medical Sciences, Uppsala University, Uppsala, Sweden
  1. Correspondence to Dr Yaara Ben-Yosef, PixCell Medical Ltd., 6 Hayezira st., POB 113, Yokneam Ilit 20692, Israel; yaara{at}pixcell-medical.com

Abstract

Background and aims A haematology analyser, based on a new technology, is presented herein. The analyser that provides a complete blood count (CBC) and five-part differential accepts disposable cartridges containing all required reagents, making it maintenance-free and ideal for point-of-care (POC) settings. The test reproducibility and imperviousness to analytical errors are attributed to the imaging-based analysis employed. Imaging enables cell-morphology-based differentiation, which is analogous to the gold standard microscopic analysis. This article presents the HemoScreen new technology and evaluates its performance through a small-scale study conducted in its designated clinical settings.

Methods Thirty anticoagulated whole blood samples were analysed on the HemoScreen and Sysmex XE-2100. Linear regression was performed for the methods comparison. Two samples with 15 replicates were processed for imprecision. Ease of use of the device was also considered.

Results The HemoScreen demonstrated acceptable imprecision and good agreement with the Sysmex XE-2100. The white blood cells (WBCs), red blood cells (RBCs), haemoglobin (HGB), haematocrit (HCT), platelets (PLT), neutrophils, lymphocytes and eosinophils have coefficients of correlation (r) >0.97. For mean cell volume (MCV), mean cell HGB (MCH) and RBC distribution width (RDW), r values ranged from 0.92 to 0.96. For mean cell HGB concentration (MCHC) and monocytes r=0.82 was demonstrated. User-friendliness and suitability of the device for operation in the designated POC settings was also confirmed.

Conclusions The HemoScreen employs innovative technologies of viscoelastic focusing and microfluidics within a disposable cartridge for an image-based blood cell analysis. By providing accurate and repeatable CBC and five-part differential results within minutes and maintaining the simplicity of operation, the HemoScreen could have far-reaching implications for use at POC. Further extended evaluation is in progress.

  • POC TESTING
  • HAEMATOLOGY
  • CELL COUNTING
  • IMAGE ANALYSIS
  • DIAGNOSTICS
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