Charm EZ-M Mycotoxin Analyzer

Overview

The Charm EZ-M Mycotoxin Analyzer is a fully integrated, benchtop immunoassay detection platform engineered for rapid, quantitative analysis of mycotoxins in grain, feed, and food matrices. Based on lateral flow immunoassay (LFIA) technology with chromogenic signal detection, the EZ-M combines precise thermal incubation and high-sensitivity optical readout in a single compact unit. It is designed to interpret results from Charm ROSA® (Rapid One-Step Assay) test strips—pre-calibrated, antibody-based lateral flow devices that generate visually quantifiable colorimetric signals proportional to mycotoxin concentration. The system eliminates manual incubation timing and subjective visual interpretation, replacing them with programmable temperature control, automated strip recognition, and algorithm-driven signal quantification. Its architecture supports routine compliance testing in quality control laboratories operating under FDA, USDA, and EU regulatory frameworks for mycotoxin limits in agricultural commodities.

Key Features

• Integrated incubation and optical readout: Eliminates need for external incubators or separate readers.
• Automated ROSA strip recognition: Identifies assay type via embedded strip barcode or predefined pattern recognition, automatically selecting the appropriate analytical channel (e.g., aflatoxin, deoxynivalenol, zearalenone, fumonisin).
• Intelligent incubation protocol selection: Automatically sets optimal temperature (37°C or 45°C) and incubation duration (5–15 min) based on selected sample matrix (corn, wheat, barley, soy, finished feed) and dilution factor.
• Real-time volume verification: Optical fluid detection confirms adequate sample application prior to incubation, preventing invalid runs due to underfilling.
• Self-diagnostic system: Performs hardware initialization checks (LED calibration, sensor alignment, temperature stability) at startup and during operation; alerts users to potential procedural deviations (e.g., premature lid opening, strip misalignment).
• Robust data integrity architecture: Internal flash memory stores up to 8,000 test records with full metadata (operator ID, timestamp, sample ID, dilution, assay type, result, pass/fail flag); removable SD card extends capacity to ≥100,000 records with timestamped audit trail.
• LIMS-ready connectivity: Supports bidirectional data exchange via USB 2.0, SD card export (CSV/Excel-compatible), and optional Wi-Fi module for secure integration into laboratory information management systems compliant with 21 CFR Part 11 requirements.
• Modular design: Removable, autoclavable sample chamber facilitates rapid cleaning and cross-contamination prevention between batches.

Sample Compatibility & Compliance

The EZ-M analyzer is validated for use with all Charm ROSA® mycotoxin test strips, including but not limited to ROSA Aflatoxin, ROSA DON (deoxynivalenol), ROSA Zearalenone, ROSA Fumonisin, ROSA T-2/HT-2 toxin, and ROSA Ochratoxin A. It supports extraction protocols aligned with AOAC Official Method 2005.02, EN 14123, and ISO 12409 for cereal and feed samples. Results are traceable to NIST-traceable reference standards and meet performance criteria specified in EU Commission Regulation (EC) No 1881/2006 and FDA Action Levels for mycotoxins in food and feed. The device operates within GLP-compliant environments and supports electronic record retention per FDA 21 CFR Part 11 when paired with validated LIMS software.

Software & Data Management

The onboard firmware provides intuitive touchscreen navigation with multilingual UI options (English, Spanish, French, German, Chinese). All test records include immutable timestamps, operator login credentials, and instrument serial number. Data export formats include CSV and Excel (.xlsx), preserving numerical results, qualitative flags (Pass/Fail), and raw optical density values. Audit logs capture every user action—including method changes, calibration events, and data deletion attempts—for internal QA review. Optional software packages enable remote firmware updates, centralized fleet monitoring, and automated report generation aligned with ISO/IEC 17025 documentation requirements.

Applications

• Pre-harvest and post-harvest grain receiving inspection at elevators and mills
• In-process testing in animal feed manufacturing facilities
• Finished product release testing in pet food and aquafeed production
• Contract laboratory services supporting third-party certification (e.g., GMP+, FSSC 22000, BRCGS)
• Regulatory surveillance programs conducted by national food safety authorities
• Research applications requiring rapid screening prior to confirmatory LC-MS/MS analysis

FAQ

Does the EZ-M require external calibration with reference standards before each run?
No. The system performs automatic optical self-calibration at startup using internal reference LEDs; routine verification with Charm-provided control strips is recommended daily.
Can the EZ-M be used with non-Charm lateral flow strips?
No. The EZ-M is exclusively validated for Charm ROSA® assays. Strip geometry, conjugate pad composition, and control line kinetics are proprietary and optimized for this platform.
What happens if the incubation chamber door is opened mid-assay?
The system immediately halts incubation, invalidates the test, and displays an error code; no result is stored or reported.
Is wireless data transmission encrypted?
Yes. When configured with the optional Wi-Fi module, data transfer uses TLS 1.2 encryption and integrates with enterprise-grade authentication protocols (WPA2-Enterprise, RADIUS).
How often must the optical sensor be cleaned?
The sensor window should be wiped with lint-free, alcohol-moistened swabs after every 50 tests or whenever visible residue is observed; full chamber cleaning is recommended after each shift.