Evergreen MS-GDS Pathogenic Bacterial Gene Detection System

Overview

The Evergreen MS-GDS Pathogenic Bacterial Gene Detection System is a fully integrated, benchtop multiplex real-time polymerase chain reaction (qPCR) platform engineered for rapid, specific, and sensitive identification of clinically relevant bacterial pathogens directly from enriched or processed clinical, food, or environmental samples. Unlike conventional single-plex PCR instruments, the MS-GDS implements a proprietary probe-and-primer design strategy grounded in stringent bioinformatic validation against NCBI RefSeq and FDA-recognized pathogen genomic databases. It operates on the principle of hydrolysis probe-based fluorescence detection (TaqMan chemistry), enabling simultaneous quantification and discrimination of up to 8 distinct bacterial targets—including Salmonella enterica, Listeria monocytogenes, Escherichia coli O157:H7, Staphylococcus aureus, and Campylobacter jejuni—within a single reaction well. The system is designed for deployment in diagnostic microbiology labs, food safety QC facilities, and public health reference laboratories requiring CLIA- or ISO 15189-aligned workflows.

Key Features

• Multiplexed Target Discrimination: Patented primer-probe sets are pre-optimized for minimal cross-reactivity and validated across >200 non-target strains, delivering analytical specificity ≥99.8% per target under standardized amplification conditions.
• Integrated Internal Control Architecture: Each reaction tube contains a synthetic, non-human, non-bacterial internal amplification control (IAC) co-amplified with sample DNA, enabling real-time monitoring of extraction efficiency, PCR inhibition, and assay integrity.
• High Sensitivity Detection: Achieves limit-of-detection (LoD) down to 10–50 genomic copies per reaction for key pathogens, supported by high-yield DNA enrichment modules and low-background optical detection optics calibrated per IEC 61000-4-3 EMC standards.
• Benchtop Workflow Integration: Includes dedicated GDS nucleic acid concentration module, vortex mixer (2500 rpm, ±5%), 8-channel adjustable-volume pipettes (1–200 µL), repeat pipettor (0.5–50 µL), and single-channel precision pipettes (0.1–10 µL), all traceable to NIST standards.
• Thermal Performance: Block uniformity ≤±0.25°C across all 96 wells; ramp rate up to 5.0°C/sec (heating) and 4.5°C/sec (cooling); temperature accuracy ±0.1°C at 60°C (verified per ASTM E2757).

Sample Compatibility & Compliance

The MS-GDS accepts purified genomic DNA extracted from swabs, stool, milk, meat homogenates, water filters, and blood culture broths using commercially available or in-house validated kits (e.g., QIAamp DNA Mini, MagMAX Pathogen RNA/DNA Kit). All reagent kits supplied with the system carry CE-IVD marking and comply with ISO 13485:2016 quality management requirements. The platform supports audit-ready operation under GLP and GMP environments: instrument logs retain full thermal cycle metadata, user authentication records, and run-specific calibration reports for ≥12 months. Data export formats (CSV, PDF, .rdml) conform to MIQE guidelines and support integration into LIMS platforms compliant with 21 CFR Part 11 for electronic signatures and audit trails.

Software & Data Management

Controlled via Windows-based Evergreen GDS Suite v3.2, the software provides intuitive assay setup, automatic baseline/threshold assignment, multi-target melt curve analysis, and delta-Ct relative quantification. Raw fluorescence data (.eds files) are stored with embedded cryptographic hashes to ensure data integrity. The suite includes built-in QC dashboards tracking inter-run CVs (<5% for Ct values), amplification efficiency (90–110%), and no-template control (NTC) signal thresholds. All software updates undergo regression testing per ISO/IEC 17025:2017 Annex A.3 and are delivered with version-controlled release notes and validation documentation packages upon request.

Applications

• Routine surveillance of foodborne pathogens in dairy, poultry, and produce processing lines
• Confirmatory testing of presumptive isolates in clinical microbiology laboratories
• Environmental monitoring in pharmaceutical cleanrooms per ISO 14644-1 Class 5–8 specifications
• Outbreak investigation support for public health agencies using standardized Ct-based strain clustering
• Validation of antimicrobial resistance gene markers (e.g., bla_CTX-M, vanA) in conjunction with culture-based AST

FAQ

Is the MS-GDS compatible with third-party qPCR master mixes?
Yes—provided the mix is compatible with hydrolysis probe chemistry and has been verified for absence of PCR inhibitors under the instrument’s thermal profile.
Does the system support automated sample loading?
No—the MS-GDS is a manual-load platform optimized for flexibility and cost control; robotic liquid handling integration requires external OEM interface development.
What regulatory documentation is provided with the system?
Each unit ships with a Factory Acceptance Test (FAT) report, Certificate of Conformance, Software Validation Summary, and a complete set of installation qualification (IQ) and operational qualification (OQ) protocols aligned with ISO/IEC 17025 and USP .
Can assay panels be customized for emerging pathogens?
Yes—Evergreen offers a custom assay development service based on client-submitted genomic sequences, subject to biosecurity review and delivery within 8–12 weeks.
Is remote diagnostics and software update support available?
Yes—secure TLS 1.2–enabled remote access is available under signed support agreements, with all updates undergoing change control per ISO 9001:2015 Clause 8.5.6.