Hamamatsu C10066-50 Fluorescent Immunochromatographic Analyzer
| Brand | Hamamatsu |
|---|---|
| Origin | Japan |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Origin | Imported |
| Model | C10066-50 |
| Pricing | Available Upon Request |
Overview
The Hamamatsu C10066-50 Fluorescent Immunochromatographic Analyzer is a dedicated benchtop optical detection system engineered for quantitative fluorescence intensity measurement from lateral flow immunoassay (LFIA) strips labeled with fluorescent nanoparticles—such as europium chelate microparticles, quantum dots, or polymer-based fluorophores. It operates on the principle of excitation-emission photometry: a precisely collimated LED or laser source illuminates the test and control lines of the strip, while a high-sensitivity silicon photodiode or CCD-based detector captures emitted fluorescence under defined spectral filtering conditions. The instrument delivers calibrated, background-subtracted fluorescence signal values (in arbitrary units or relative fluorescence units, RFU), enabling absolute or semi-quantitative concentration determination when used with reference standards. Designed for R&D laboratories and QC/QA departments in IVD manufacturing, the C10066-50 supports method development, lot-to-lot consistency verification, and stability testing under controlled environmental conditions.
Key Features
- High-sensitivity fluorescence detection optimized for common LFIA labels—including lanthanide chelates (e.g., Eu³⁺), near-infrared (NIR) dyes, and fluorescent latex beads—with configurable excitation/emission wavelength combinations.
- Automated line-scan acquisition across multiple assay zones (sample pad, conjugate pad, test line, control line) to ensure spatially resolved quantification and minimize positional variability.
- Integrated thermal stabilization module maintaining detector and optical path temperature within ±0.5 °C, ensuring long-term signal reproducibility across multi-hour measurement sessions.
- Calibration traceability via onboard reference standards; optional NIST-traceable fluorescence calibration kits available for GLP-compliant workflows.
- Robust mechanical stage accommodating diverse strip formats—including standard 5 mm wide cassettes, naked nitrocellulose membranes, and custom-cut lateral flow devices up to 80 mm in length.
Sample Compatibility & Compliance
The C10066-50 accepts all standard lateral flow formats used in clinical diagnostics, food safety, and environmental testing—regardless of membrane type (nitrocellulose, nylon, PVDF), conjugate label chemistry, or housing design. It is compatible with both single- and multiplexed test configurations. From a regulatory perspective, the system supports audit-ready operation in environments governed by ISO 13485, FDA 21 CFR Part 11 (when paired with compliant software configuration), and ICH Q5C stability guidelines. Instrument performance verification follows Hamamatsu’s internal PQ protocol, including daily system suitability checks using certified reference strips and annual preventive maintenance per manufacturer-recommended intervals.
Software & Data Management
The included Hamamatsu FluoroScan Control Software (v3.x or later) provides full instrument control, real-time preview, and post-acquisition analysis. Data export is natively supported in CSV format—structured with columns for timestamp, strip ID, test/control line RFU values, signal-to-noise ratio, and user-defined metadata fields—ensuring seamless integration into Excel, JMP, or LIMS platforms. Audit trail functionality logs all user actions, parameter changes, and calibration events with timestamps and operator IDs. Optional software modules enable statistical process control (SPC) charting, dose-response curve fitting (4PL/5PL), and batch comparison reports aligned with ISO/IEC 17025 reporting requirements.
Applications
- Development and optimization of fluorescent LFIA assays for infectious disease biomarkers (e.g., SARS-CoV-2 nucleocapsid, influenza A/B antigens).
- Quality control of commercial rapid test kits during manufacturing release, including sensitivity verification, precision assessment (within-run and between-day CV ≤ 5%), and shelf-life monitoring.
- Comparative evaluation of alternative fluorescent labels, conjugation chemistries, and membrane lot variations.
- Supporting regulatory submissions by generating instrument qualification documents (IQ/OQ/PQ), measurement uncertainty estimates, and raw data archives compliant with ALCOA+ principles.
- Academic and contract research settings requiring traceable, publication-grade fluorescence quantification without reliance on proprietary reader ecosystems.
FAQ
What fluorescence labels are validated for use with the C10066-50?
Hamamatsu provides compatibility documentation for europium(III) chelate particles (excitation ~365 nm, emission ~615 nm), Alexa Fluor 647 (excitation ~650 nm), and IRDye 800CW (excitation ~774 nm). Custom excitation/emission filter sets can be ordered for other fluorophores.
Can the C10066-50 be integrated into automated production lines?
Yes—the instrument supports RS-232 and Ethernet communication protocols, enabling remote triggering, parameter loading, and data retrieval via SCADA or MES systems. PLC-compatible digital I/O signals are available as an optional hardware add-on.
Is firmware update support provided after purchase?
Hamamatsu offers free firmware updates for the lifetime of the product, delivered through secure download with version-controlled release notes and backward-compatible file handling.
Does the system meet electromagnetic compatibility (EMC) requirements for laboratory use?
The C10066-50 complies with IEC 61326-1:2013 for laboratory equipment, including immunity to electrostatic discharge (ESD), radiated RF fields, and fast transient bursts—certified by third-party testing labs in Japan and EU.
