Novel, standardized sample collection from the brain-nose interface

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

doi:10.1016/j.ymeth.2024.12.012

Novel, standardized sample collection from the brain-nose interface

Methods. 2025 Jan 2:S1046-2023(24)00286-X. doi: 10.1016/j.ymeth.2024.12.012. Online ahead of print.

Authors

Marion San Nicoló¹, Sabine Mertzig², Alexander Berghaus³, Oliver Peters⁴, Lutz Frölich⁵, Timo Grimmer⁶, Jens Wiltfang⁷, Timo Oberstein⁸, Thomas Braun⁹, Maria Babu², Hilary Wunderlich², Peter Kaspar², Gabriele Baur², Christian Braun¹⁰, Mohammad Bashiri², Heinz Oehl², Thomas Heydler², Mareike Albert²

Affiliations

¹ Noselab GmbH, Widenmayerstr. 27, 80538 Munich, Germany. Electronic address: Marion.sannicolo@noselab.com.
² Noselab GmbH, Widenmayerstr. 27, 80538 Munich, Germany.
³ ENT Private Practice, Oskar-von-Miller-Ring 1, 80333 München, Germany.
⁴ Charité-Universitätsmedizin Berlin, Department of Psychiatry, Berlin, Germany.
⁵ Department of Geriatric Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
⁶ Technical University Munich, Center for Cognitive Disorders, Munich, Germany.
⁷ Universitätsmedizin Göttingen, Department of Psychiatry, Goettingen, Germany.
⁸ Department of Psychiatry and Psychotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), 91054 Erlangen, Bayern, Germany.
⁹ Otorhinolaryngologist, Augsburg, Germany.
¹⁰ LMU Munich, Institute of Legal Medicine, Munich, Germany.

PMID: 39755347
DOI: 10.1016/j.ymeth.2024.12.012

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.

Keywords: Biomarkers; Cerebrospinal fluid; Nasal secretion; Neurodegenerative diseases; Non-invasive.