Novel, standardized sample collection from the brain-nose interface.

Area of Science:

• Neurology
• Biomarker Discovery
• Medical Device Development

Background:

• Current diagnostics for neurodegenerative diseases lack non-invasive early-stage screening methods.
• Biomarkers for neurodegenerative diseases can be found in nasal secretions via the brain-nose interface (BNI).
• Nasal secretion sample collection from the BNI offers a promising non-invasive diagnostic approach.

Purpose of the Study:

• To evaluate a novel medical device, nosecollect, for standardized collection of nasal secretion samples from the BNI.
• To assess the safety and efficiency of the nosecollect device for sample acquisition.

Main Methods:

• A Class I medical device, nosecollect, was developed for user-friendly, safe, and comfortable BNI sample collection.
• A clinical study involving 923 participants across 8 centers evaluated the device's performance, safety, and tolerability.
• Trained medical personnel collected samples using the nosecollect device.

Main Results:

• The nosecollect device successfully collected a mean volume of 452 ± 317 μl from the BNI.
• Successful positioning of the absorption material in the BNI was achieved in 95% of cases.
• Minimal pain (VAS = 1.97 ± 1.99) and adverse events (1%) were reported, with no serious adverse events.

Conclusions:

• The nosecollect device provides standardized, targeted, and safe collection of non-diluted nasal secretion samples from the BNI.
• This device outperforms traditional methods like swabs or lavage for BNI sample access.
• nosecollect represents a significant advancement for a non-invasive diagnostic platform for neurodegenerative diseases using BNI samples.