The HemoScreen, a novel haematology analyser for the point of care

Ben-Yosef, Yaara; Marom, Barak; Hirshberg, G. E.; Dsouza, Carol; Larsson, Anders; Bransky, Avishay

doi:10.1136/jclinpath-2015-203484

Cited by 38 publications

(44 citation statements)

References 17 publications

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“…dimensions, a cellphone adaptor weighing ∼18 g) and have the advantage of providing test results at or near a patient. [7][8][9][10][11][12][13] In the United States, a Clinical Laboratory Improvement Amendments (CLIA)-waived test classification is required to use these devices in a clinical setting. It defines the test accuracy of a leukocyte differential to be within AE15% of a clinical hematology analyzer while being simple enough for an inexperienced user to operate.…”

Section: Introductionmentioning

confidence: 99%

“…18,19 For instance, an arbitrary total count of 10,000 cells would only consist of 400 to 1000 monocytes while only 4 to 10 monocytes would be available to count in a population of 100 cells, which reduces the likelihood of detecting that small population. 19 While many POC blood analyzers have achieved results within CLIA standards, 9,12,20 the combination of the device simplicity and accurate monocyte counts can be challenging design factors.…”

Section: Introductionmentioning

confidence: 99%

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Considerations for point-of-care diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test

et al. 2017

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Considerations for point-ofcare diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test," J. Biomed. Opt. 22(3), 035001 (2017), doi: 10.1117/1.JBO.22.3.035001. Abstract. There exists a broad range of techniques that can be used to classify and count white blood cells in a point-of-care (POC) three-part leukocyte differential test. Improvements in lenses, light sources, and cameras for image-based POC systems have renewed interest in acridine orange (AO) as a contrast agent, whereby subpopulations of leukocytes can be differentiated by colorimetric analysis of AO fluorescence emission. We evaluated the effect on test accuracy using different AO staining and postprocessing methods in the context of an image-based POC colorimetric cell classification scheme. Thirty blood specimens were measured for percent cell counts using our POC system and a conventional hematology analyzer for comparison. Controlling the AO concentration used during whole-blood staining, the incubation time with AO, and the colorimetric ratios among the three population of leukocytes yielded a percent deviation of 0.706%, −1.534%, and −0.645% for the lymphocytes, monocytes, and granulocytes, respectively. Overall, we demonstrated that a redshift in AO fluorescence was observed at elevated AO concentrations, which lead to reproducible inaccuracy of cell counts. This study demonstrates there is a need for a strict control of the AO staining and postprocessing methods to improve test accuracy in these POC systems. © The Authors. Published by SPIE under a Creative Commons Attribution 3.0 UnportedLicense. Distribution or reproduction of this work in whole or in part requires full attribution of the original publication, including its DOI.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Considerations for point-of-care diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test

et al. 2017

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“…Overall, the precision results could still be considered acceptable, following allowable total error criteria as defined by CLIA guidelines 9 and are in line with these obtained with other comparable POC hematology analyzers. [10][11][12] For 19 of 115 samples, the Spinit ® -BC assay gave no result for one or more parameters. Eleven of these samples could be repeated, of which 6 samples generated a reliable result for all parameters.…”

Section: Performance Evaluation Of the Spinit ® -Bc A New Point-ofcamentioning

confidence: 98%

Performance evaluation of the Spinit^®‐BC, a new point‐of‐care assay for total WBC count with 5‐part differential and hematocrit measurement

Graindor

Blomme

Jughmans

et al. 2017

Int J Lab Hematology

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“…These prior efforts on POCT CBC measurements require either complex sample preparation such as purifying different cell types and handling multiple reagents , measure only single parameters , or measure multiple parameters with separate instrumentation . A recently reported automated CBC (HemoScreen by PixCell Medical, Yokneam Illit, Israel) utilizes viscoelastic flow combined with image analysis with good imprecision (3%‐7% on RBC, WBC and PLT counts) on a wide range of CBC parameters . However, it requires 40 μL of blood, which is incompatible the ~10 μL of blood obtainable with a standard finger prick blood draw .…”

Section: Introductionmentioning

confidence: 99%

Performance of a cost‐effective and automated blood counting system for resource‐limited settings operated by trained and untrained users

Xie

Liu

Tong

et al. 2017

Journal of Biophotonics

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Current flow-based blood counting devices require expensive and centralized medical infrastructure and are not appropriate for field use. In this article we report a streamlined, easy-to-use method to count red blood cells (RBC), white blood cells (WBC), platelets (PLT) and 3-part WBC differential through a cost-effective and automated image-based blood counting system. The approach consists of using a compact, custom-built microscope with large field-of-view to record bright-field and fluorescence images of samples that are diluted with a single, stable reagent mixture and counted using automatic algorithms. Sample collection utilizes volume-controlled capillary tubes, which are then dropped into a premixed, shelf-stable solution to stain and dilute in a single step. Sample measurement and analysis are fully automated, requiring no input from the user. Cost of the system is minimized through the use of custom-designed motorized components. We compare the performance of our system, as operated by trained and untrained users, to the clinical gold standard on 120 adult blood samples, demonstrating agreement within Clinical Laboratory Improvement Amendments guidelines, with no statistical difference in performance among different operator groups. The system's cost-effectiveness, automation and performance indicate that it can be successfully translated for use in low-resource settings where central hematology laboratories are not accessible.

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The HemoScreen, a novel haematology analyser for the point of care

Cited by 38 publications

References 17 publications

Considerations for point-of-care diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test

Considerations for point-of-care diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test

Performance evaluation of the Spinit^®‐BC, a new point‐of‐care assay for total WBC count with 5‐part differential and hematocrit measurement

Performance of a cost‐effective and automated blood counting system for resource‐limited settings operated by trained and untrained users

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The HemoScreen, a novel haematology analyser for the point of care

Cited by 38 publications

References 17 publications

Considerations for point-of-care diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test

Considerations for point-of-care diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test

Performance evaluation of the Spinit®‐BC, a new point‐of‐care assay for total WBC count with 5‐part differential and hematocrit measurement

Performance of a cost‐effective and automated blood counting system for resource‐limited settings operated by trained and untrained users

Contact Info

Product

Resources

About

Performance evaluation of the Spinit^®‐BC, a new point‐of‐care assay for total WBC count with 5‐part differential and hematocrit measurement