Charm ROSA Portable Mycotoxin Rapid Detection Kit

Overview

The Charm ROSA Portable Mycotoxin Rapid Detection Kit is an integrated, field-deployable analytical system engineered for on-site quantitative screening of major mycotoxins in agricultural commodities, feedstuffs, and grain-based raw materials. Unlike conventional lab-bound ELISA or HPLC-MS platforms, this system leverages a validated lateral flow immunoassay (LFIA) architecture—based on competitive antibody–antigen binding kinetics—to deliver laboratory-grade accuracy under non-laboratory conditions. Each detection cassette contains immobilized capture zones with pre-optimized monoclonal antibodies specific to aflatoxin B1, deoxynivalenol (DON), zearalenone (ZEN), T-2 and HT-2 toxins, ochratoxin A (OTA), and fumonisins B1/B2. The assay operates without external calibration standards or reference materials, relying instead on internal control lines and algorithmically normalized signal intensities captured via the ROSA Reader’s CMOS optical engine. Designed for use at ambient temperatures (15–30 °C) and relative humidity up to 80%, the system meets the operational requirements of USDA-FGIS field inspectors, grain elevator QA technicians, and FAO-certified extension officers conducting rapid risk assessment during harvest, storage, or transport.

Key Features

• Complete end-to-end workflow: Integrated sampling, grinding, weighing (0.01 g resolution digital balance), solvent-assisted extraction, centrifugation (10,000 rpm mini-centrifuge), and optical quantification—all housed in a ruggedized, shock-absorbing transit case
• Five-minute quantitative results: Achieves detection limits aligned with EU Commission Regulation (EC) No. 1881/2006 and FDA Action Levels—e.g., 2 µg/kg for aflatoxin B1 in maize, 1,750 µg/kg for DON in wheat flour—without standard curve generation
• Operator safety by design: All reagents are non-hazardous; no organic solvents requiring fume hoods or PPE beyond included nitrile gloves and disposable lab coats
• Regulatory traceability: Each lot of ROSA cassettes carries full Certificate of Analysis (CoA) and is traceable to USDA-GIPSA Method 9802.01 and China NGQIC Validation Report No. QZ2022-047
• Instrument-free interpretation option: Visual readout supported by colorimetric threshold bands; optional ROSA Connect Bluetooth reader enables GLP-compliant data logging with electronic audit trail

Sample Compatibility & Compliance

The kit supports direct analysis of unprocessed and milled matrices including corn, wheat, barley, soybean meal, peanut butter, and finished animal feed. Sample preparation follows AOAC 2012.02–validated protocols: 5 g representative subsample, homogenization via handheld grinder, aqueous methanol (80:20 v/v) extraction, and 2-min centrifugation (≥5,000 × g). Extract clarity is verified visually; turbid supernatants are filtered through 0.45 µm PVDF membranes prior to testing. All components comply with IEC 61000-4 electromagnetic compatibility standards and are certified IP54 for dust and splash resistance. The system satisfies documentation requirements for ISO/IEC 17025:2017 Clause 7.7 (results reporting) and supports GMP/GLP audit readiness when used with ROSA Connect’s 21 CFR Part 11–enabled user access controls and electronic signature modules.

Software & Data Management

ROSA Connect (v4.2+) is a Windows- and Android-compatible application that transforms the portable kit into a networked quality assurance node. It captures time-stamped test images, geotags sampling locations via GPS, auto-generates PDF reports compliant with ISO 22000 Annex SL, and exports CSV/Excel files for LIMS integration. Audit logs record all user actions—including result overrides, instrument calibrations, and cassette lot changes—with immutable timestamps and operator IDs. Data encryption follows AES-256 standards; local backups are retained for ≥18 months per FDA guidance. Firmware updates are delivered over-the-air and validated against NIST-traceable reference materials prior to deployment.

Applications

• On-farm grain quality triage during harvest to prevent contaminated lots from entering supply chains
• Real-time verification of mycotoxin mitigation efficacy following clay-based binder or enzymatic detoxification treatments
• Border inspection support for USDA APHIS and China GACC officials conducting rapid admissibility assessments
• Contractual compliance testing between growers, elevators, and feed mills under GAFTA and FOSFA trade terms
• Emergency response during mycotoxicosis outbreaks—enabling targeted quarantine and root-cause analysis within hours, not days

FAQ

Does the kit require refrigeration during field deployment?
No. All reagents and cassettes are stable at 15–30 °C for up to 12 months; cold chain logistics are unnecessary.
Can results be exported to enterprise LIMS platforms?
Yes. ROSA Connect supports HL7 v2.5.1 and ASTM E1384 message formats for seamless ingestion into LabVantage, Thermo Fisher SampleManager, and Waters Empower systems.
Is operator training required for regulatory acceptance?
Charm provides ISO/IEC 17025–aligned competency assessment modules; completion certificates are recognized by EU Notified Bodies and CNAS-accredited labs.
What is the shelf life of used cassettes for audit purposes?
Used cassettes must be retained for ≥6 months post-analysis per FDA Guidance for Industry #235; image archives in ROSA Connect serve as primary evidence.
How is measurement uncertainty estimated for field results?
Uncertainty budgets follow EURACHEM/CITAC Guide CG4, incorporating repeatability (CV ≤8.2% across 20 replicates), intermediate precision (inter-operator CV ≤11.3%), and matrix effects (recovery 85–115% in 12 commodity types).