An automated integrated platform for rapid and sensitive multiplexed protein profiling using human saliva samples.

Area of Science:

• Biomedical Engineering
• Clinical Diagnostics
• Point-of-Care Testing

Background:

• Saliva is an emerging biofluid for noninvasive diagnostic testing.
• Current diagnostic methods for respiratory diseases can be time-consuming.
• There is a need for rapid, field-deployable diagnostic tools.

Purpose of the Study:

• To develop and validate an automated, integrated platform for respiratory disease diagnosis using saliva.
• To enable diagnosis by minimally trained personnel in field settings.
• To provide timely protein biomarker profiling for clinical assistance.

Main Methods:

• A microfluidic chip-based platform was developed for saliva analysis.
• Automated analyzer (SDReader) performs simultaneous measurement of protein biomarkers.
• Microsphere-based array and fluorescence sandwich immunoassays were employed.
• A custom algorithm analyzes optical readouts for results.

Main Results:

• The automated assay requires only 10 μL of saliva and reports results in 70 minutes.
• Platform performance was comparable to a 3.5-hour lab bench assay.
• Successfully tested 273 saliva samples in two clinical environments.

Conclusions:

• The automated saliva analysis platform demonstrates potential for assisting clinicians in diagnosing respiratory diseases.
• The device facilitates noninvasive sample collection and automated analysis for point-of-care diagnostics.
• This technology offers timely protein biomarker information for improved patient management.