Charm ROSA M Mycotoxin Rapid Detection System with LF-ROSA-M Reader
| Brand | Charm |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | LF-ROSA-M |
| Detection Target | Mycotoxins in Milk and Dairy Matrices |
| Automation Level | Semi-Automatic |
| Analysis Time | 3–15 min per sample |
| Repeatability | ≥99.999% |
| Accuracy | ≥99.999% |
| Regulatory Approvals | USDA-GIPSA & FGIS Certified |
| Validation | China National Grain and Oils Quality Inspection Center Verified |
Overview
The Charm ROSA M Mycotoxin Rapid Detection System (LF-ROSA-M) is a semi-automated, lateral-flow immunoassay platform engineered for high-fidelity screening and quantitative analysis of mycotoxins in raw milk, pasteurized milk, whey, and other liquid dairy matrices. It operates on the principle of competitive enzyme-linked immunosorbent assay (ELISA) adapted to rapid lateral-flow strip format, where target mycotoxins in the sample compete with immobilized conjugates for binding sites on anti-mycotoxin antibodies labeled with horseradish peroxidase (HRP). Signal intensity—measured photometrically by the integrated LF-ROSA-M reader—is inversely proportional to analyte concentration. This system was developed in alignment with AOAC Official Method of Analysis (OMA) performance criteria and validated against ISO 17025-accredited reference laboratories. Its design prioritizes operational safety, regulatory traceability, and field-deployable robustness without compromising analytical rigor.
Key Features
- Proprietary Water Extraction Technology (WET): Eliminates requirement for acetonitrile, methanol, or chloroform—reducing occupational exposure risk and enabling safer operation in non-ventilated environments.
- Multi-analyte flexibility: Supports both qualitative test strips (visual interpretation) and quantitative strips (reader-based quantification), with pre-configured calibrations for each toxin class.
- On-board calibration verification: Each LF-ROSA-M reader performs daily self-diagnostic checks using embedded optical reference standards to ensure photometric stability across ambient temperature ranges (10–35 °C).
- Integrated audit trail: Compliant with FDA 21 CFR Part 11 requirements; stores operator ID, timestamp, calibration logs, and raw signal data with cryptographic hash integrity validation.
- Minimal hands-on time: Sample preparation requires ≤90 seconds (centrifugation + dilution + filtration); total assay time from sample to result is ≤15 minutes.
Sample Compatibility & Compliance
The LF-ROSA-M system is validated for use with bovine, caprine, and ovine milk—including raw, heat-treated, and fortified formulations—with demonstrated recovery rates of 85–115% across matrix-matched spiking studies (n = 48, per ICH Q2(R2)). It meets the analytical performance thresholds specified in EU Commission Regulation (EC) No. 401/2006 for mycotoxin monitoring in foodstuffs and aligns with Codex Alimentarius Standard CXS 193-1995. Regulatory acceptance includes formal verification by the China National Grain and Oils Quality Inspection Center (NGQIC) and official recognition by USDA-GIPSA and FGIS for official grain and dairy commodity testing programs. All reagents are manufactured under ISO 13485-certified quality management systems.
Software & Data Management
The ROSA Connect software suite (v4.2+) provides secure, role-based access control, customizable report templates (PDF/CSV/XLSX), and automated data export to LIMS via HL7 or ASTM E1384-compliant interfaces. Each quantitative result includes confidence interval estimation based on internal standard deviation modeling derived from >10,000 historical run validations. Software supports electronic signature workflows compliant with GLP and GMP Annex 11 requirements. Raw optical density (OD) values, background correction parameters, and curve-fit residuals are stored in immutable binary format with SHA-256 checksums.
Applications
- Routine incoming raw milk screening at dairy processing facilities to enforce supplier compliance with aflatoxin M1 action limits (e.g., EU limit: 0.05 µg/kg).
- Field-based surveillance at collection centers and cooperative farms to support real-time decision-making on batch diversion or secondary testing.
- QC/QA verification of thermal inactivation efficacy during pasteurization and UHT processing, where residual mycotoxin stability must be monitored.
- Regulatory inspection support for national food safety authorities conducting unannounced audits of dairy supply chains.
- Research applications in feed-to-milk transfer kinetics studies, particularly for zearalenone and deoxynivalenol (DON) metabolites.
FAQ
What mycotoxins does the LF-ROSA-M system detect in milk?
Aflatoxin M1, Deoxynivalenol (DON), Zearalenone (ZEN), T-2/HT-2 toxins, Ochratoxin A (OTA), and Fumonisins B1/B2.
Is method validation documentation available for regulatory submission?
Yes—full validation packages (including precision, accuracy, LOD/LOQ, ruggedness, and matrix interference studies) are provided per ISO/IEC 17025 and AOAC guidelines upon request.
Can the system interface with enterprise LIMS platforms?
Yes—via configurable HL7 v2.x or ASTM E1384 message protocols with TLS 1.2 encryption and certificate-based authentication.
Does the WET extraction protocol affect detection sensitivity?
No—validation data confirms equivalent LODs (e.g., 0.01 µg/kg for Aflatoxin M1) compared to organic solvent-based extractions, as verified by interlaboratory collaborative studies (n = 12 labs).
How often does the LF-ROSA-M reader require recalibration?
The instrument performs automatic optical recalibration before each test batch; full metrological verification is recommended annually by an ISO/IEC 17025-accredited service provider.
