一种用于真空辅助采集毛细血管血标本的简化上臂装置的评估

Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens.

作者信息

Schaff Ulrich Y, Collier Bradley B, Iacovetti Gabriella, Peevler Mitchell, Ragar Jason, Tokunaga Nicolas, Brandon Whitney C, Chappell Matthew R, Grant Russell P, Sommer Greg J

机构信息

Diagnostic Devices Research and Development, Labcorp, Pleasanton, CA 94588, USA.

Center for Esoteric Testing, Labcorp, Burlington, NC 27215, USA.

出版信息

Diagnostics (Basel). 2025 Jul 31;15(15):1935. doi: 10.3390/diagnostics15151935.

Abstract

Conventional blood collection can be challenging in a non-clinical or home-based setting. In response, vacuum-assisted lancing devices for capillary blood collection (typically from the upper arm) have gained popularity to broaden access to diagnostic testing. However, these devices are often costly relative to the reimbursement rate for common laboratory testing panels. This study describes the design and evaluation of Comfort Draw™, a simplified and economical vacuum-assisted capillary blood collection device. Comfort Draw™ was evaluated by 12 participants in a preliminary study and by 42 participants in a follow-up study. Metrics assessed included the following: vacuum pressure of the device, skin temperature generated by the Comfort Draw prep warmer, blood collection volume, and analytical accuracy (for 19 common serum-based analytes). Acceptable blood volume (>400 µL) and serum volume (>100 µL) were collected by Comfort Draw in 85.5% and 95.1% of cases, respectively. Seventeen of the nineteen analytes examined were within CLIA acceptance limits compared to matched venous samples. Self-reported pain scores associated with Comfort Draw collection averaged 0.39 on a scale from 0 to 10. In this preliminary clinical study, Comfort Draw was found to be a valid and relatively painless method for collecting capillary blood specimens. The device's simple design and lower cost could enable broader applications compared to more complex alternative capillary blood collection devices.

摘要

在非临床或家庭环境中,传统的采血方式可能具有挑战性。作为回应,用于采集毛细血管血(通常采自上臂)的真空辅助采血装置越来越受欢迎,以扩大诊断检测的可及性。然而,相对于常见实验室检测项目的报销率而言,这些装置往往成本高昂。本研究描述了一种简化且经济的真空辅助毛细血管采血装置Comfort Draw™的设计与评估。在一项初步研究中,12名参与者对Comfort Draw™进行了评估,在后续研究中,42名参与者也参与了评估。评估的指标包括:该装置的真空压力、Comfort Draw预暖器产生的皮肤温度、采血量以及分析准确性(针对19种常见的基于血清的分析物)。在85.5%的案例中,Comfort Draw采集到了可接受的血量(>400微升),在95.1%的案例中采集到了可接受的血清量(>100微升)。与配对的静脉样本相比,所检测的19种分析物中有17种在临床实验室改进修正案(CLIA)的可接受范围内。与Comfort Draw采血相关的自我报告疼痛评分平均为0.39(0至10分制)。在这项初步临床研究中,发现Comfort Draw是一种采集毛细血管血标本的有效且相对无痛的方法。与更复杂的替代性毛细血管采血装置相比,该装置的简单设计和较低成本可能使其具有更广泛的应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c97f/12345872/59108063b6ab/diagnostics-15-01935-g001.jpg

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