BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
J Pharm Biomed Anal. 2024 Dec 15;251:116454. doi: 10.1016/j.jpba.2024.116454. Epub 2024 Aug 28.
Low volume sampling technologies have gained popularity as they are minimally invasive, reduce patient burden, enhance population diversity, and have the potential to facilitate decentralized clinical trials. Herein, we validated a Gyrolab assay to measure soluble Mucosal Addressin Cell Adhesion Molecule 1 (sMAdCAM-1) in dried blood samples collected using two low volume sampling devices, Mitra and Tasso-M20. This validated assay was implemented in a proof-of-concept study to compare three low volume sampling devices (Mitra, Tasso-M20 and TassoOne Plus) with serum collected via venipuncture from healthy volunteers receiving etrolizumab. We observed significantly higher concentration of sMAdCAM-1 in dried blood samples collected using Mitra and Tasso-M20 compared to serum in some paired samples, which was attributed to interference from the dried blood extraction buffer. To mitigate this interference, samples required substantial dilution into the appropriate buffer, which negatively impacted the detectability of sMAdCAM-1 with the Gyrolab assay. By employing the Quanterix single molecule array (Simoa), known for its superior assay sensitivity, the interference was minimized in the diluted samples. Both liquid blood collected in TassoOne Plus and dried blood collected using Mitra and Tasso-M20 demonstrated great concordance with serum for sMAdCAM-1 measurement. However, a bias was observed in Mitra dried blood samples, presumably due to the different sample collection sites in comparison with venipuncture and Tasso devices. Our study highlights the potential of low volume sampling technologies for biomarker analysis, and underscores the importance of understanding the challenges and limitations of these technologies before integrating them into clinical studies.
低容量采样技术因其微创、减轻患者负担、增强人群多样性，并有可能促进分散临床试验而受到关注。在此，我们验证了 Gyrolab 测定法，用于测量使用两种低容量采样装置（Mitra 和 Tasso-M20）采集的干血样本中可溶性黏膜地址素细胞黏附分子 1（sMAdCAM-1）。该验证测定法在概念验证研究中实施，用于比较三种低容量采样装置（Mitra、Tasso-M20 和 TassoOne Plus）与通过静脉穿刺从接受依特立珠单抗治疗的健康志愿者采集的血清。我们观察到，在一些配对样本中，与血清相比，使用 Mitra 和 Tasso-M20 采集的干血样本中 sMAdCAM-1 的浓度显著更高，这归因于干血提取缓冲液的干扰。为了减轻这种干扰，需要将样品大量稀释到适当的缓冲液中，这对 Gyrolab 测定法检测 sMAdCAM-1 的灵敏度产生负面影响。通过使用 Quanterix 单分子阵列（Simoa），该方法以其卓越的测定灵敏度而闻名，可最大限度地减少稀释样品中的干扰。在 TassoOne Plus 中采集的液体血液和使用 Mitra 和 Tasso-M20 采集的干血在测量 sMAdCAM-1 方面与血清具有很好的一致性。然而，在 Mitra 干血样本中观察到偏差，可能是由于与静脉穿刺和 Tasso 装置相比，采样部位不同所致。我们的研究强调了低容量采样技术在生物标志物分析中的潜力，并强调在将这些技术整合到临床研究之前，了解这些技术的挑战和限制的重要性。
