Charm ROSA Antibiotic Residue Detection System
| Brand | Charm |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Import Status | Imported |
| Model | Charm ROSA |
| Price Range | USD 7,000 – 28,000 |
Overview
The Charm ROSA Antibiotic Residue Detection System is a field-deployable, immunoassay-based rapid screening platform engineered for the qualitative and semi-quantitative detection of antibiotic residues in raw milk, urine, and other liquid food matrices. It operates on the principle of lateral flow immunochromatography using colloidal gold-labeled antibodies—specifically designed to bind target analytes (e.g., β-lactams, tetracyclines, chloramphenicol, sulfonamides) in competitive inhibition format. Upon sample application, unbound antibiotics in the specimen compete with immobilized antigen conjugates for limited antibody binding sites on the test strip. The resulting color intensity at the test line is inversely proportional to analyte concentration, enabling visual or instrument-assisted interpretation. ROSA is validated under AOAC Official Method of Analysis (OMA) and aligned with EU Commission Regulation (EU) No 37/2010 and FDA Guidance for Industry on Residue Testing in Milk. Its design prioritizes operational robustness in non-laboratory environments—including dairy collection points, mobile testing units, and veterinary clinics—without requiring refrigerated reagent storage or trained laboratory personnel.
Key Features
- Single-step assay: Add 300 µL sample directly to the test strip; no extraction, centrifugation, or dilution required.
- 8-minute total assay time—from sample application to result readout—enabling high-throughput screening of >50 samples per hour per operator.
- ROSA Reader instrument with integrated optical sensor, automatic line intensity quantification, and built-in calibration verification using reference strips.
- Data management capacity: Stores up to 4,800 test records with timestamp, operator ID, strip lot number, and result classification (Pass/Fail/Invalid).
- Comprehensive quality control: Each kit includes certified positive controls traceable to NIST-matched reference materials, supporting GLP-compliant documentation.
- Modular configuration: Base system comprises ROSA Reader, thermal incubator (for temperature-sensitive assays), and disposable test strips—minimizing capital investment for decentralized deployment.
Sample Compatibility & Compliance
The Charm ROSA system demonstrates validated performance across raw bovine milk (including high-fat, high-somatic-cell-count, and mastitic samples), caprine and ovine milk, and bovine urine. It accommodates samples with pH 6.4–6.8 and fat content ≤4.5% without interference. All SL-series strips (SL-5, SL-6, SL-TET) are registered with the U.S. FDA Center for Veterinary Medicine (CVM) and listed in the European Reference Laboratory for Antimicrobial Resistance (EURL-AR) validated methods database. MRL-series strips meet EU Maximum Residue Level thresholds defined in Regulation (EC) No 470/2009 and are compliant with ISO/IEC 17025:2017 for testing laboratories. The system supports audit-ready electronic records meeting FDA 21 CFR Part 11 requirements when paired with Charm’s ROSA DataLink software and secure network configuration.
Software & Data Management
ROSA DataLink software (Windows-compatible, version 4.2+) provides encrypted data export in CSV and PDF formats, customizable report templates (including farm-level summary dashboards), and integration with LIMS via HL7 or ODBC drivers. Audit trails record all user actions—including result overrides, calibration events, and firmware updates—with immutable timestamps and digital signatures. Software validation packages (IQ/OQ/PQ protocols) are available for regulated facilities operating under GMP or ISO 22000 frameworks. Firmware updates are delivered via USB or Ethernet, ensuring alignment with evolving regulatory thresholds and emerging antibiotic classes.
Applications
- Routine screening of bulk tank milk at dairy farms and receiving stations to prevent antibiotic-contaminated loads from entering processing lines.
- On-farm mastitis treatment monitoring via urine analysis to verify withdrawal periods prior to milk return.
- Regulatory compliance testing by national food safety authorities conducting surveillance programs under Codex Alimentarius standards.
- Contract testing laboratories performing accredited residue analysis as part of third-party certification (e.g., GlobalG.A.P., SQF, BRCGS).
- Veterinary diagnostic support for antimicrobial stewardship initiatives in ruminant health management programs.
FAQ
What antibiotics does the SL-6 test strip detect?
The SL-6 strip detects penicillin G, ampicillin, cloxacillin, dicloxacillin, nafcillin, oxacillin, and oxacillin analogs—including newly added邻-chloramphenicol (as specified in EU Annex I).
Can ROSA be used for pasteurized or processed milk?
No—ROSA is validated exclusively for raw,未经heat-treated milk and urine. Thermal denaturation of target antibiotics or matrix interference invalidates results in processed products.
Is training required to operate the ROSA system?
Minimal training is required: operators complete a 90-minute competency assessment covering strip handling, reader operation, and basic troubleshooting—no prior immunoassay experience necessary.
How often must the ROSA Reader be calibrated?
Calibration is performed automatically at startup using internal reference optics; annual verification with Charm-certified calibration strips is recommended for ISO 17025 compliance.
Are ROSA test strips stable at ambient temperature?
Yes—SL-series strips maintain full sensitivity for 18 months when stored at 2–30°C; no cold chain logistics are required for distribution or field use.
