Analytical validation of a novel capillary finger-stick blood sampling device for clinical chemistry, complete blood count, and hemoglobin A1c testing

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-10-14 DOI:10.1016/j.cca.2025.120664

Yasuhiro Sakai , Taku Kato , Midori Saito , Michiko Osawa , Kazuya Shinmura , Koichi Seto , Kuniaki Saito , Hiroyasu Ito

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Abstract

Background and aims

Capillary Cup® is a novel finger-stick blood collection device equipped with separation float technology to effectively isolate plasma and blood cell layers. This study aimed to evaluate its analytical equivalence compared to venipuncture sampling in clinical chemistry, complete blood count, and hemoglobin A1c testing.

Methods

Blood samples were collected from 63 healthy participants for clinical chemistry and hemoglobin A1c tests and 67 for complete blood count tests. Discrepancies between the Capillary Cup® and venipuncture sampling results were analyzed using the 2025 Clinical Laboratory Improvement Amendments (CLIA) acceptance limits and total allowable error (TE_A) thresholds.

Results

The Capillary Cup® samples showed strong linear correlations with venipuncture samples across proteins, transaminases, kidney function markers, lipids, C-reactive protein, blood cell and platelet counts, white blood cell differentials, hemoglobin, hematocrit, and Wintrobe's indices (r = 0.740–0.999, P < 0.0001). Hemoglobin A1c was accurately measured alongside other clinical chemistry markers in a single kit (r = 0.976, P < 0.0001). All values met the 2025 CLIA acceptance limits, and most also met the TE_A thresholds. Minor deviations were observed for creatinine, triglycerides, and C-reactive protein, as well as for platelet counts—potentially affected by activation and aggregation—but all remained within acceptance limits and demonstrated preserved linearity.

Conclusions

The Capillary Cup® provides analytically equivalent results to venipuncture for all tested parameters. It is easy to use, reduces waste, and is a potential alternative for at-home health monitoring, addressing challenges in venous access, and reducing iatrogenic blood loss risk in clinical practice.

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一种用于临床化学、全血细胞计数和血红蛋白A1c检测的新型毛细管指棒采血装置的分析验证。

背景和目的：毛细管杯®是一种新型的手指棒式采血装置，配备分离浮子技术，可有效分离血浆和血细胞层。本研究旨在评价其与静脉穿刺取样在临床化学、全血细胞计数和血红蛋白A1c检测方面的分析等效性。方法：对63例健康人进行临床化学和糖化血红蛋白检测，67例进行全血细胞计数检测。使用2025年临床实验室改进修正案（CLIA）可接受限度和总允许误差（TEA）阈值分析毛细管杯®和静脉穿刺取样结果之间的差异。结果：毛细管杯®样品与静脉穿刺样品在蛋白质、转氨酶、肾功能标志物、脂质、c反应蛋白、血细胞和血小板计数、白细胞差异、血红蛋白、红细胞压积和Wintrobe指数上呈强线性相关（r = 0.740-0.999，P A阈值）。在肌酸酐、甘油三酯和c反应蛋白以及血小板计数中观察到轻微的偏差——可能受到活化和聚集的影响——但所有这些都保持在可接受范围内，并显示出保留的线性。结论：毛细管杯®在所有测试参数上提供了与静脉穿刺分析等效的结果。它易于使用，减少浪费，是家庭健康监测的潜在替代方案，解决静脉通路的挑战，并在临床实践中降低医源性失血风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.