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评估低体积血浆采样用于临床样本中美罗培南分析的情况。

Evaluation of low-volume plasma sampling for the analysis of meropenem in clinical samples.

作者信息

Parker Suzanne L, Wallis Steven C, Fourie Cheryl, Lassig-Smith Melissa, Starr Therese, Chikatamarla Avinash, Dorofaeff Tavey, Chatfield Mark D, Lipman Jeffrey, Roberts Jason A

机构信息

UQ Centre for Clinical Research, The University of Queensland, Brisbane, Australia.

Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, Australia.

出版信息

Anal Bioanal Chem. 2022 Mar;414(6):2155-2162. doi: 10.1007/s00216-021-03851-1. Epub 2022 Jan 3.

Abstract

Reducing the volume of blood sampled from neonatal or paediatric patients is important to facilitate research in a group that is under-represented in clinical studies. Not all patients have a cannula available for blood sampling, meaning there are real advantages in obtaining a blood microsample by skin prick. In this study, the results obtained from both capillary microsamples (CMS) and a microfluidic (MF)-CMS by skin prick are compared to conventional plasma sampled from an arterial catheter in a clinical bridging study. Six critically ill patients receiving meropenem were included with the incurred sample reanalysis test meeting the acceptance criteria for both CMS (n = 24 samples) and MF-CMS (n = 20 samples). Bland-Altman plots comparing MF-CMS to conventional arterial blood sampling revealed a difference of - 12.7 ± 22.1% (mean ± standard deviation (SD), and comparing CMS to conventional arterial blood sampling a difference of - 3.4 ± 17.0%. At - 12.7%, the bias between MF-CMS and conventional sampling is greater than the bias found with CMS, although within the limit of acceptability for analytical accuracy (that being ± 15%). Samples collected by skin prick and using CMS produced meropenem concentrations that were comparable to those obtained from conventional arterial catheter sampling. CMS samples were found to be stable when stored in the capillary tube for 24 h at 5 °C or for 4 h at room temperature.

摘要

减少从新生儿或儿科患者采集的血量对于推动临床研究中代表性不足群体的研究至关重要。并非所有患者都有可供采血的套管,这意味着通过皮肤穿刺获取微量血样具有实际优势。在本临床桥接研究中,将通过皮肤穿刺获得的毛细血管微量血样(CMS)和微流控(MF)-CMS的结果与从动脉导管采集的传统血浆结果进行比较。纳入了6例接受美罗培南治疗的重症患者,所进行的样本再分析测试符合CMS(n = 24个样本)和MF-CMS(n = 20个样本)的验收标准。比较MF-CMS与传统动脉血采样的布兰德-奥特曼图显示差异为-12.7±22.1%(均值±标准差(SD)),比较CMS与传统动脉血采样的差异为-3.4±17.0%。MF-CMS与传统采样之间-12.7%的偏差大于CMS的偏差,尽管在分析准确性的可接受限度内(即±15%)。通过皮肤穿刺并使用CMS采集的样本产生的美罗培南浓度与从传统动脉导管采样获得的浓度相当。发现CMS样本在毛细管中于5°C下储存24小时或在室温下储存4小时时是稳定的。

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