Charm EZ Antibiotic Detection System
| Brand | Charm |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | EZ |
| Price Range | USD 7,000 – 28,000 |
Overview
The Charm EZ Antibiotic Detection System is a fully integrated, benchtop immunoassay platform engineered for rapid, on-site or laboratory-based screening of antibiotic residues in milk, dairy products, and other liquid food matrices. It operates on the principle of competitive lateral flow immunoassay (LFIA), where target analytes—such as β-lactams, tetracyclines, sulfonamides, aminoglycosides, macrolides, and chloramphenicol—compete with immobilized conjugates for binding sites on antibody-coated test strips (Charm ROSA® strips). The system combines precise thermal incubation and high-sensitivity optical detection in a single compact unit, eliminating the need for separate incubators or external readers. Designed for compliance with international residue monitoring frameworks—including EU Commission Regulation (EU) No 37/2010, FDA Grade A Pasteurized Milk Ordinance (PMO), and Codex Alimentarius standards—the EZ system delivers regulatory-grade data suitable for routine quality control (QC), supplier verification, and pre-shipment screening.
Key Features
- Integrated incubation and optical readout in one instrument—no external hardware required
- Automated, real-time adjustment of incubation temperature (37 °C ± 0.5 °C), time (1–15 min), and optical channel selection based on strip colorimetric signature
- Results displayed within 60 seconds post-read; quantitative or qualitative interpretation per strip batch calibration
- Capacitive touchscreen interface with intuitive icon-driven navigation and multilingual support (English, Spanish, French, German, Chinese, Arabic)
- Dual-layer data storage: internal flash memory (8,000 test records) + removable industrial-grade SD card (100,000 records, FAT32 formatted)
- Modular connectivity: optional Ethernet, Wi-Fi (802.11 b/g/n), or Bluetooth 5.0 modules for LIMS integration, remote diagnostics, and audit trail export
- Removable, autoclavable sample chamber with IP54-rated sealing for simplified cleaning and cross-contamination mitigation
- Self-calibrating optical engine with LED-based RGB illumination and CMOS sensor array optimized for ROSA® strip spectral response (520–650 nm)
Sample Compatibility & Compliance
The Charm EZ system is validated exclusively for use with Charm ROSA® lateral flow test strips—certified under ISO/IEC 17025-accredited methods and compliant with AOAC PTM and NordVal validation protocols. It supports all ROSA strip formats targeting over 15 antibiotic classes: β-lactams (penicillins, cephalosporins), tetracyclines, sulfonamides, streptomycin/dihydrostreptomycin, chloramphenicol, quinolones, lincomycin, erythromycin, tylosin, gentamicin, spectinomycin, kanamycin, neomycin, and β-lactamase. Sample types include raw and pasteurized bovine, caprine, and ovine milk; whey; reconstituted powdered milk; and liquid dairy blends. The system meets GLP documentation requirements and supports 21 CFR Part 11-compliant electronic signatures when paired with CharmLink™ Software v4.2+ and networked authentication.
Software & Data Management
CharmLink™ Desktop Software (v4.2 or later) enables centralized method management, user role assignment (admin/operator/auditor), and automated report generation in PDF/CSV formats. All test metadata—including strip lot number, operator ID, sample ID, timestamp, environmental temperature/humidity logs, and raw pixel intensity values—are embedded in each record. Audit trails are immutable and timestamped, supporting GMP-aligned traceability. Data export supports HL7 and ASTM E1384 message structures for seamless integration into enterprise LIMS (e.g., LabWare, Thermo Fisher SampleManager, STARLIMS). Firmware updates are delivered via signed USB drive or secure OTA push, with version rollback capability and SHA-256 integrity verification.
Applications
- Routine screening of bulk tank milk at dairy farms and receiving stations
- QC release testing of finished dairy products prior to distribution
- Verification of antibiotic withdrawal periods in veterinary-supervised herds
- Third-party certification labs performing accredited residue testing (ISO/IEC 17025)
- Regulatory inspection units conducting unannounced surveillance sampling
- Research applications assessing matrix interference or new analyte cross-reactivity profiles
FAQ
Is the Charm EZ system compatible with non-Charm lateral flow strips?
No. The optical calibration, incubation algorithm, and result interpretation logic are specifically engineered for Charm ROSA® strips. Use of third-party strips voids regulatory compliance and invalidates AOAC/NordVal validation claims.
Does the EZ system require daily calibration or maintenance?
No daily calibration is required. The system performs automatic optical self-checks at power-on and before each assay. Annual verification using Charm Traceable Calibration Strips (Cat. No. 7000-001) is recommended for ISO/IEC 17025 compliance.
Can test results be exported directly to a cloud-based LIMS?
Yes—when equipped with the optional Wi-Fi or Ethernet module and configured with CharmLink™ Cloud Gateway, results synchronize in near real time with authorized cloud LIMS instances via TLS 1.2 encrypted RESTful API.
What is the operating temperature range for field deployment?
The instrument is rated for ambient operation between 10 °C and 35 °C, with relative humidity ≤80% non-condensing. Battery-powered operation (optional external 12 V DC pack) supports mobile use in refrigerated trucks or farm-side testing stations.
How does the system handle strip lot-to-lot variability?
Each ROSA® strip lot includes a QR-coded calibration card scanned at startup. The EZ system loads lot-specific sensitivity curves and decision thresholds, ensuring consistent cutoff accuracy across manufacturing batches.
