AutoMolec 3000 Integrated Automated Nucleic Acid Extraction and Real-Time Fluorescent PCR System
| Brand | Autobio |
|---|---|
| Model | AutoMolec 3000 |
| Origin | Henan, China |
| Sample Throughput | 3000 tests/day |
| Heating Rate | 4 °C/s |
| Temperature Accuracy | ±0.1 °C |
| Well-to-Well Temperature Uniformity | ±0.5 °C |
| Detection Limit | <100 copies/mL |
| Cycle Time per Sample | ~100 min |
| Compliance | ISO 13485, CE-IVD, NMPA Registration No. 20223400123 |
Overview
The AutoMolec 3000 Integrated Automated Nucleic Acid Extraction and Real-Time Fluorescent PCR System is an IVD-grade benchtop platform engineered for end-to-end molecular diagnostics—combining magnetic-bead-based nucleic acid purification with real-time quantitative PCR (qPCR) amplification and detection in a single, closed-tube workflow. Unlike modular or semi-automated systems requiring manual transfer between extraction and amplification modules, the AutoMolec 3000 employs a unified fluidic architecture with integrated robotics, thermal cyclers, and optical detection units to eliminate cross-contamination risk and reduce hands-on time to near zero. The system operates on the principle of TaqMan probe hydrolysis and SYBR Green intercalation, supporting dual-channel fluorescence detection (FAM/HEX or FAM/VIC) with real-time data acquisition at every cycle. Designed for high-complexity clinical laboratories and decentralized testing sites, it delivers full traceability from sample loading to result reporting—meeting core requirements for CLIA-waived operation under defined use conditions and supporting GLP/GMP-aligned audit trails.
Key Features
- Fully automated walk-away workflow: integrated lysis, binding, washing, elution, and qPCR setup without human intervention after initial loading
- Single-sample random access capability: supports STAT processing of individual specimens amid batch runs without interrupting ongoing assays
- Closed-tube, contamination-minimized design: all reagent handling occurs within sealed cartridges; no open-tube transfers post-extraction
- High-precision thermal control: Peltier-based heating/cooling blocks with active temperature feedback ensure ±0.1 °C accuracy and ≤±0.5 °C well-to-well uniformity across all 96 reaction positions
- Optimized optical detection: LED excitation sources paired with high-sensitivity photodiodes enable reliable quantification down to <100 copies/mL across linear dynamic range of 10¹–10⁸ copies/mL
- Modular cartridge architecture: pre-filled, lyophilized master mix cartridges reduce pipetting errors and simplify inventory management
Sample Compatibility & Compliance
The AutoMolec 3000 accepts primary clinical specimens including nasopharyngeal swabs (in UTM/VTM), saliva, plasma, serum, and bronchoalveolar lavage fluid. Sample input volume ranges from 200–1000 µL, with automatic dilution and normalization applied where required. All consumables—including extraction kits, qPCR cartridges, and waste containers—are CE-IVD marked and registered with China’s NMPA (Registration No. 20223400123). The system complies with ISO 13485:2016 for medical device quality management systems and supports 21 CFR Part 11–compliant electronic signatures and audit logs when deployed with validated LIMS integration. It meets ASTM E2923-21 standards for verification of nucleic acid quantification performance and is validated per ISO/IEC 17025 for method-specific precision and reproducibility.
Software & Data Management
The embedded AutoMolec Control Suite v4.2 provides intuitive touchscreen operation with multi-level user authentication (admin, technician, reviewer). Software features include assay template library management, customizable run protocols, real-time amplification curve visualization, Ct value auto-calling with adjustable baseline and threshold settings, and export of MIQE-compliant qPCR data (CSV, PDF, XML). Audit trail records capture operator ID, timestamp, parameter changes, calibration events, and error logs—with immutable storage retained for ≥12 months. Integration with hospital LIS or enterprise LIMS is supported via HL7 v2.5.1 and ASTM E1384 interfaces. Remote monitoring and firmware updates are performed over secure TLS 1.2 connections.
Applications
The AutoMolec 3000 is validated for infectious disease testing—including SARS-CoV-2, influenza A/B, RSV, and Mycoplasma pneumoniae—as well as oncology-related gene expression panels (e.g., EGFR, KRAS) and antimicrobial resistance markers (e.g., mecA, vanA). Its 3000-test-per-day throughput enables deployment in regional reference labs, emergency departments, and point-of-care molecular hubs. The system supports multiplexed detection of up to four targets per reaction well, facilitating syndromic respiratory or gastrointestinal panels. Method validation studies demonstrate >98.7% sensitivity and 99.2% specificity against orthogonal sequencing-based confirmation across >15,000 clinical samples.
FAQ
Does the AutoMolec 3000 support custom assay development?
Yes—open protocol mode allows loading of non-registered assays using third-party master mixes and primers/probes, subject to internal validation per ISO 15189 requirements.
What maintenance intervals are recommended?
Daily decontamination, weekly optical calibration, and quarterly robotic arm alignment—documented in the service logbook and tracked via onboard maintenance scheduler.
Is remote diagnostic support available?
Yes—embedded telemetry enables secure remote access by Autobio-certified field service engineers for troubleshooting and performance verification.
Can results be exported in STARD or REMARK-compliant formats?
Raw fluorescence data and analysis metadata conform to MIQE guidelines and can be structured for STARD-compliant reporting upon request.
How is carryover contamination prevented between runs?
UV-C irradiation (254 nm) of the sample carousel and aerosol-resistant barrier filters in all fluidic paths ensure ≤10⁻⁶ carryover probability per run, verified per CLSI EP17-A2.
