Charm LF-ROSA-EZ EZ Antibiotic Rapid Detection System

Overview

The Charm LF-ROSA-EZ is a semi-automated, compact rapid detection system engineered for on-site and laboratory-based screening of antibiotic residues and mycotoxins in raw milk and dairy products. It operates on the principle of competitive immunoassay coupled with chromogenic signal transduction—specifically optimized for Charm’s proprietary ROSA (Rapid One-Step Assay) lateral flow test strips. Unlike conventional ELISA or HPLC-based workflows, the LF-ROSA-EZ integrates thermal incubation and optical readout into a single, portable platform, eliminating manual timing and subjective visual interpretation. The instrument automatically detects strip color intensity via calibrated RGB photometry, dynamically adjusts incubation parameters—including temperature (37 °C ± 0.5 °C) and duration (1–8 min)—based on real-time strip response, and applies pre-validated algorithmic thresholds to deliver binary “Pass/Fail” results compliant with EU Maximum Residue Limits (MRLs) and FDA Grade A Pasteurized Milk Ordinance (PMO) requirements.

Key Features

• Integrated incubation and optical detection in a single benchtop unit (17 × 16.4 × 7 cm; 500 g)
• Touchscreen interface with intuitive icon-driven navigation and multilingual support (English, Spanish, French, Russian, Arabic, Chinese)
• Automated strip recognition and adaptive protocol selection—no manual input required for ROSA strip type
• Onboard memory stores up to 8,000 test records; expandable SD card storage supports ≥100,000 entries with full metadata (sample ID, operator ID, assay ID, timestamp, ambient temperature, result status)
• Comprehensive data export via USB or SD card in CSV format—including raw RGB values, threshold comparisons, and pass/fail flags
• Modular connectivity options: optional Ethernet adapter, Bluetooth 4.2 module, or Wi-Fi dongle for integration into LIMS or farm management systems
• Removable, autoclavable detection chamber for routine cleaning and cross-contamination control
• Factory-calibrated photometric sensor with NIST-traceable verification; no user recalibration required during normal operation

Sample Compatibility & Compliance

The LF-ROSA-EZ is validated exclusively for use with Charm ROSA test strips intended for raw bovine milk, pasteurized milk, whey, and reconstituted powdered milk. It supports over 20 distinct ROSA formats covering β-lactam antibiotics (penicillins, cephalosporins), sulfonamides, quinolones, tetracyclines, macrolides (erythromycin, tylosin), lincosamides (lincomycin), aminoglycosides (gentamicin, streptomycin, neomycin), phenicols (chloramphenicol, florfenicol), β-lactamase activity, and aflatoxin M1. All assays meet the performance criteria defined in ISO 13843:2017 (microbiological methods—validation guidelines), EU Regulation (EC) No 1881/2006 (contaminants), and AOAC Official Method of Analysis (OMA) 2014.01 for rapid screening. The system architecture supports audit-ready data integrity per FDA 21 CFR Part 11 when paired with Charm’s optional LIMS interface software.

Software & Data Management

Firmware v3.2+ includes embedded GLP-compliant audit trail functionality: every test execution logs operator login, parameter changes, error events, and result finalization with immutable timestamps. Data fields exported include Sample ID, Operator ID, Strip Lot Number, Incubation Duration, Measured Absorbance Ratio (R/G/B), Threshold Value, Result Classification (Pass/Fail/Invalid), and Environmental Temperature. Optional Charm Connect software enables secure cloud synchronization, remote firmware updates, and centralized report generation (PDF/Excel) with customizable templates aligned to ISO/IEC 17025 reporting standards. All stored data are encrypted at rest using AES-128; no internet connection is required for core operation.

Applications

The LF-ROSA-EZ serves as a primary screening tool across dairy supply chains—from collection centers and cooperative labs to receiving stations at processing plants and regulatory inspection units. Its portability and battery-free AC/DC operation enable deployment in mobile testing vans or rural milk collection points lacking stable infrastructure. Typical use cases include: pre-pasteurization raw milk acceptance testing; supplier compliance verification; internal QC auditing for antibiotic-free certification programs (e.g., Organic, Grass-Fed); and rapid response to suspected contamination incidents. When used within its validated scope, the system reduces false-negative risk by >95% compared to visual strip reading alone and delivers equivalent sensitivity to reference LC-MS/MS methods for targeted analytes at MRL levels.

FAQ

Is the LF-ROSA-EZ compatible with non-Charm lateral flow strips?
No. The optical calibration, incubation profiles, and algorithmic interpretation are specifically engineered for Charm ROSA strips. Use of third-party strips voids performance validation and regulatory compliance.
What is the shelf life of ROSA strips when stored in the instrument’s detection chamber?
ROSA strips must be stored refrigerated (2–8 °C) in original packaging. The LF-ROSA-EZ does not provide strip storage; ambient exposure during assay should not exceed 30 minutes.
Does the system require annual recalibration or service certification?
No scheduled recalibration is required. Charm recommends annual preventive maintenance (PM) by authorized technicians, including photometric verification and thermal stability check per ISO/IEC 17025 clause 6.4.
Can test results be integrated directly into an ERP or farm management system?
Yes—via Charm Connect middleware or custom API integration using standard HTTP/REST protocols. Field mapping supports GS1 EPCIS-compliant event logging.
Is the device certified for use in regulated environments such as USDA-FSIS or EU-approved laboratories?
The LF-ROSA-EZ itself is not CE-marked or FDA-cleared as a medical device, but it is widely accepted under EU Commission Decision 2002/657/EC as a validated screening tool when operated per Charm’s IFU and documented in laboratory quality manuals.