Novel, standardized sample collection from the brain-nose interface

IF 4.2 3区生物学 Q1 BIOCHEMICAL RESEARCH METHODS

Methods Pub Date : 2025-02-01 DOI:10.1016/j.ymeth.2024.12.012

Marion San Nicoló , Sabine Mertzig , Alexander Berghaus , Oliver Peters , Lutz Frölich , Timo Grimmer , Jens Wiltfang , Timo Oberstein , Thomas Braun , Maria Babu , Hilary Wunderlich , Peter Kaspar , Gabriele Baur , Christian Braun , Mohammad Bashiri , Heinz Oehl , Thomas Heydler , Mareike Albert

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引用次数: 0

Abstract

Background

Diagnostics for neurodegenerative diseases lack non-invasive approaches suitable for early-stage biochemical screening and routine examination of neuropathology. Biomarkers of neurodegenerative diseases pass through the brain-nose interface (BNI) and accumulate in nasal secretion. Sample collection from the brain-nose interface presents a compelling prospect as basis for a non-invasive molecular diagnosis of neuropathologies. Here, we evaluated a novel medical device (nosecollect) that is tailored for the standardized collection of nasal secretion samples from BNI, focusing on its sample collection safety and efficiency.

Method

A class I medical device (nosecollect) was developed, to enable the standardized collection of nasal secretion exclusively from BNI in a user-friendly, safe, and comfortable manner. We performed a clinical study to test the collection device on a heterogenous cohort (n = 923) at 8 study centers and evaluated its performance to collect sufficient sample volume from the targeted BNI area, its safety and tolerability. Samples were collected by trained medical personnel (medical doctors and nurses).

Results

Nosecollect gathered a mean volume of 452 ± 317 μl from the BNI. Successful positioning of the absorption material (AM) in the BNI was observed in 95 % of the cases. Pain level/level of discomfort and occurrences of adverse events remained minimal (visual analogue scale (VAS) = 1.97 ± 1.99 (range 0–10), adverse events: 1 %, no serious adverse events). Analysis of the nasal secretion sample identified detectable levels of CNS biomarkers in it.

Conclusions

The precision and ergonomic design of nosecollect ensures a standardized, targeted and safe collection of non-diluted nasal secretion samples from BNI, thus outperforming traditional methods such as swabs, lavage etc which are not customized for accessing undiluted samples from BNI. In addition, the device offers a non-invasive and accessible approach for the acquisition of nasal secretion samples from BNI, signifying a crucial step in the future development of a BNI-based non-invasive diagnostic platform for neurodegenerative diseases.

Abstract Image

查看原文本刊更多论文

从脑-鼻接口采集新颖的标准化样本。

背景：神经退行性疾病的诊断缺乏适合早期生化筛查和神经病理学常规检查的无创方法。神经退行性疾病的生物标志物通过脑鼻界面（BNI）并在鼻腔分泌物中积累。从脑-鼻交界面采集样本，作为神经病理非侵入性分子诊断的基础，呈现出令人信服的前景。在这里，我们评估了一种新型的医疗设备（nosecollect），该设备是为BNI的鼻分泌物样本的标准化采集量身定制的，重点是其样本采集的安全性和效率。方法：研制I类医疗器械（nosecollect），以方便、安全、舒适的方式对BNI的鼻分泌物进行标准化采集。我们进行了一项临床研究，在8个研究中心的异质队列（n = 923）中测试收集装置，并评估其从目标BNI区域收集足够样本量的性能，其安全性和耐受性。样本由训练有素的医务人员（医生和护士）收集。结果：Nosecollect采集BNI的平均体积为452 ± 317 μl。在95% %的病例中观察到吸收材料（AM）在BNI中的成功定位。疼痛程度/不适程度和不良事件的发生保持最小（视觉模拟评分（VAS） = 1.97 ± 1.99（范围0-10），不良事件：1 %，无严重不良事件）。对鼻分泌物样本的分析确定了其中可检测的中枢神经系统生物标志物水平。结论：nosecollect的精确和符合人体工程的设计确保了标准化、有针对性和安全的收集BNI未稀释鼻分泌物样本，从而优于传统的拭子、灌洗等方法，这些方法无法定制获取BNI未稀释样本。此外，该设备为采集BNI的鼻分泌物样本提供了一种非侵入性和可获取的方法，这标志着未来基于BNI的神经退行性疾病非侵入性诊断平台的发展迈出了关键一步。

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

Methods 生物-生化研究方法

CiteScore

9.80

自引率

2.10%

发文量

222

审稿时长

11.3 weeks

期刊介绍： Methods focuses on rapidly developing techniques in the experimental biological and medical sciences. Each topical issue, organized by a guest editor who is an expert in the area covered, consists solely of invited quality articles by specialist authors, many of them reviews. Issues are devoted to specific technical approaches with emphasis on clear detailed descriptions of protocols that allow them to be reproduced easily. The background information provided enables researchers to understand the principles underlying the methods; other helpful sections include comparisons of alternative methods giving the advantages and disadvantages of particular methods, guidance on avoiding potential pitfalls, and suggestions for troubleshooting.