Sysmex ExoCounter Automated Exosome Analyzer
| Origin | Shanghai, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Regional Classification | Domestic (China) |
| Model | ExoCounter |
| Pricing | Available Upon Request |
Overview
The Sysmex ExoCounter Automated Exosome Analyzer is a benchtop immunoaffinity-based digital detection system engineered for the quantitative enumeration of antigen-defined exosome subpopulations directly from minimally processed biofluids. Unlike conventional ultracentrifugation- or precipitation-based isolation workflows, the ExoCounter employs a microfluidic disc platform coupled with fluorescence-labeled antibody capture and high-resolution imaging to enable label-specific, single-exosome-level counting without prior enrichment. Its core measurement principle relies on solid-phase immuno-capture followed by automated epifluorescence scanning and AI-assisted particle classification—delivering reproducible quantification of exosomes bearing CD63, CD81, EpCAM, or user-selected surface biomarkers in native serum or plasma matrices. Designed for routine adoption in academic core facilities, biopharma process development labs, and translational research units, the system operates under standardized assay conditions compliant with emerging exosome reporting guidelines (MISEV2018) and supports traceable data generation aligned with GLP-aligned documentation practices.
Key Features
- Antigen-specific exosome quantification via pre-configured or customizable antibody panels targeting clinically relevant markers (e.g., CD9, CD63, CD81, PD-L1, EGFR)
- No sample pre-enrichment required—direct analysis of 12.5 µL native human serum or EDTA-plasma
- Integrated microfluidic disc format enabling parallel processing of up to 16 samples per run with minimal cross-contamination risk
- Automated assay execution: fully hands-off incubation, washing, labeling, and imaging—no user-defined instrument parameters or calibration steps
- Dedicated disc-cleaning station included to ensure consistent disc reusability and long-term optical path stability
- Onboard quality control metrics including signal-to-noise ratio per capture zone, bead aggregation index, and background fluorescence thresholding
Sample Compatibility & Compliance
The ExoCounter demonstrates validated performance across primary human biofluids—including serum, plasma (EDTA and citrate), urine supernatants, and cell culture conditioned media—with demonstrated linearity (R² > 0.99) over a dynamic range of 1 × 10⁸ to 5 × 10¹⁰ particles/mL for CD63⁺ exosomes. All assay discs are manufactured under ISO 13485-certified cleanroom conditions and supplied sterile, individually barcoded, and lot-controlled. The system architecture supports audit-ready operation: full electronic records of run logs, image archives, and result exports comply with FDA 21 CFR Part 11 requirements when deployed with validated IT infrastructure. Assay protocols align with ISEV-endorsed minimal information standards for extracellular vesicle studies (MISEV2018), and raw imaging data is retained in vendor-neutral TIFF format for third-party reanalysis.
Software & Data Management
The ExoCounter Control Software (v3.2+) provides a locked-down, role-based interface with three access tiers: Operator (run initiation only), Supervisor (QC review and report export), and Administrator (system configuration and audit log access). All analyses generate structured CSV and PDF reports containing particle count, size distribution histogram (derived from pixel-area calibration), coefficient of variation (CV) per replicate, and flagging of outliers based on internal reference controls. Data export supports HL7-compatible LIMS integration and includes embedded metadata tags for sample ID, operator, date/time stamp, disc lot number, and antibody batch. Raw fluorescence image stacks are stored locally with SHA-256 checksum verification and may be archived to network-attached storage (NAS) or cloud repositories meeting HIPAA-compliant encryption standards.
Applications
- Biomarker discovery and validation in oncology (e.g., tumor-derived EpCAM⁺ exosomes in liquid biopsy)
- Longitudinal monitoring of exosomal PD-L1 levels during immune checkpoint inhibitor therapy
- Process consistency assessment in therapeutic exosome manufacturing (e.g., MSC-derived EV batches)
- Neurodegenerative disease research via Aβ- or tau-associated exosome quantification in CSF surrogates
- Pharmacodynamic evaluation of exosome-targeting therapeutics in preclinical models
FAQ
Is the ExoCounter suitable for use in clinical diagnostic laboratories?
The ExoCounter is CE-IVD marked for professional use in Europe and registered as a Class II medical device in China (NMPA Registration No. 2023340XXXX). It is not cleared for standalone diagnostic use in the U.S. pending FDA submission.
Can users develop custom antibody assays on this platform?
Yes—Sysmex offers a Custom Assay Development Kit (CADK) with protocol templates, validation checklists, and technical support for qualified partners seeking to deploy proprietary capture antibodies under ISO 15197 or CLSI EP17-A2 frameworks.
What maintenance is required beyond daily cleaning?
Scheduled preventive maintenance includes quarterly optical alignment verification, annual fluidic path pressure calibration, and biannual software security patching—performed remotely or on-site by certified field service engineers.
