Microvolume Blood-Sampling Device with Low Hemolysis and High Consistent Yield of Serum Components

Abstract

Background: Blood sampling by finger puncture is convenient, but the need for centrifugation and the problem of hemolysis remain, as does instability when samples must be shipped for analysis. We aimed to develop a blood-sampling device that provided high yields of serum with limited hemolysis and enabled preservation of serum components for at least 7 days at room temperature. Methods: For separation of blood cells, we devised a grooved, asymmetric, polysulfonate membrane impregnated with sucrose. We evaluated hemoglobin (Hb) concentrations in the serum, assay values for 15 frequently measured serum components (including glucose), and the stability of analytes in the device. Results: In sera from the new device, the Hb concentration was ≤0.43 mg/L. Recovered serum contained 65.0% ± 4.2% (mean ± SD; n = 41) of each of the serum components obtained by centrifugation. Serum components were stable in the device for 10 days at room temperature (25 °C). Conclusions: The newly developed device allows recovery of 60% of serum components from microvolumes of blood by finger puncture with neither degradation of analytes at room temperature nor hemolysis.

Development of Novel Paper-Based Assay for Direct Serum Separation

“…In this study, storage of paper-based assay was functional for 15 days with retained efficacy of 85% compared to fresh samples. Similarly, serum components were maintained at ≥85% of initial values after 10 days of storage using a polysulfonate membrane impregnated with sucrose for separation . Saidykhan et al (2021) developed a paper-based device for measuring fibrinogen in blood plasma using wax-printed chromatographic paper strips modified with an immobilized thrombin reagent.…”

“…Digital image analysis of the RBC travel distance was used to measure the feasibility of using this device for anti-coagulant monitoring among patients compared to controls . The blood sampling device using a grooved, asymmetrical, polysulfonate membrane with sucrose was developed for efficient serum separation . Other POCTs reported separation of plasma rather than serum using a different approach. , …”

“…15 The blood sampling device using a grooved, asymmetrical, polysulfonate membrane with sucrose was developed for efficient serum separation. 19 Other POCTs reported separation of plasma rather than serum using a different approach. 7,8 Dryness of APTT and CaCl 2 reagents in paper leads to the loss of its coagulation ability within minutes.…”

“…Similarly, serum components were maintained at ≥85% of initial values after 10 days of storage using a polysulfonate membrane impregnated with sucrose for separation. 19 Saidykhan et al (2021) developed a paper-based device for measuring fibrinogen in blood plasma using wax-printed chromatographic paper strips modified with an immobilized thrombin reagent. This study reported that storing strips in aluminum bags with a desiccant in a fridge or freezer retains strip activity and functionality for 3 weeks.…”