Abstract

BackgroundPoint-of-care (PoC) testing of platelet count (PLT) provides real-time data for rapid decision making. The goal of this study is to evaluate the accuracy and precision of platelet counting using a new microvolume (8 μL), absolute counting, 1.5 kg cytometry-based blood analyzer, the rHEALTH ONE (rHEALTH) in comparison with the International Society of Laboratory Hematology (ISLH) platelet method, which uses a cytometer and an impedance analyzer.MethodsInclusion eligibility were healthy adults (M/F) ages 18–80 for donation of fingerprick and venous blood samples. Samples were from a random N = 31 volunteers from a single U.S. site. Samples were serially diluted to test thrombocytopenic ranges. Interfering substances and conditions were tested, including RBC fragments, platelet fragments, cholesterol, triglycerides, lipids, anti-platelet antibodies, and temperature.ResultsThe concordance between the rHEALTH and ISLH methods had a slope = 1.030 and R2 = 0.9684. The rHEALTH method showed a correlation between capillary and venous blood samples (slope = 0.9514 and R2 = 0.9684). Certain interferents changed platelet recovery: RBC fragments and anti-platelet antibodies with the ISLH method; platelet fragments and anti-platelet antibodies on the rHEALTH; and RBC fragments, platelets fragments, triglycerides and LDL on the clinical impedance analyzer. The rHEALTH’s precision ranged from 3.1–8.0%, and the ISLH from 1.0–10.5%.ConclusionsThe rHEALTH method provides similar results with the reference method and good correlation between adult capillary and venous blood samples. This demonstrates the ability of the rHEALTH to provide point-of-care assessment of normal and thrombocytopenic platelet counts from fingerprick blood with high precision and limited interferences.

Highlights

  • The goal of this study is to evaluate the accuracy and precision of platelet counting using a new microvolume (8 μL), absolute counting, 1.5 kg cytometry-based blood analyzer, the rHEALTH ONE in comparison with the International Society of Laboratory Hematology (ISLH) platelet method, which uses a cytometer and an impedance analyzer

  • Certain interferents changed platelet recovery: red blood cell count (RBC) fragments and anti-platelet antibodies with the ISLH method; platelet fragments and anti-platelet antibodies on the rHEALTH; and RBC fragments, platelets fragments, triglycerides and low density lipoproteins (LDL) on the clinical impedance analyzer

  • The rHEALTH method provides similar results with the reference method and good correlation between adult capillary and venous blood samples. This demonstrates the ability of the rHEALTH to provide point-of-care assessment of normal and thrombocytopenic platelet counts from fingerprick blood with high precision and limited interferences

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Summary

Introduction

Point-of-care diagnostics deployed in local medical facilities or in-field/home offer advantages of being able to deliver faster results without the need for specimen transport or undue hardship of a patient having to travel to a medical facility. Fingerprick platelet counts can be performed in a medical PoC setting, fingerprick blood testing suitable for home use is not available. This has the potential to improve the management of patients receiving vaccines to SARS-CoV-2 [3], drugs which could induce immune thrombocytopenia [4] or platelet disorders [5]. Blood cell counts may show large variability for each drop of blood acquired [9]. These studies taken together imply that sampling method for blood cell analysis from fingerprick greatly affect its utility. Point-of-care (PoC) testing of platelet count (PLT) provides real-time data for rapid decision making. The goal of this study is to evaluate the accuracy and precision of platelet counting using a new microvolume (8 μL), absolute counting, 1.5 kg cytometry-based blood analyzer, the rHEALTH ONE (rHEALTH) in comparison with the International Society of Laboratory Hematology (ISLH) platelet method, which uses a cytometer and an impedance analyzer

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