Aurora PANA X6 Automated Nucleic Acid Purification System

Overview

The Aurora PANA X6 Automated Nucleic Acid Purification System is a high-integration, walk-away platform engineered for blood screening laboratories requiring end-to-end molecular workflow automation. Designed and validated by KHB (Shanghai Kehua Bio-Engineering Co., Ltd.), the system implements magnetic bead-based nucleic acid isolation in conjunction with integrated real-time quantitative PCR (qPCR) amplification and analysis. It operates on a modular zone architecture—comprising reagent preparation, sample pooling, magnetic separation-based extraction, qPCR setup, thermal cycling, and result interpretation—enabling true “sample-in, answer-out” operation without manual intervention between steps. The instrument is purpose-built for nucleic acid testing (NAT) in blood donor screening programs, supporting both individual and pooled sample processing under CLIA- and CAP-aligned operational principles. Its mechanical design prioritizes contamination control, traceability, and reproducibility—critical for regulatory compliance in transfusion medicine.

Key Features

• Modular Zonal Architecture: Physically segregated workspaces—including reagent dispensing, sample pooling station, magnetic bead purification module, qPCR reaction assembly unit, and thermal cycler—minimize cross-contamination risk and support parallel batch processing.
• Integrated qPCR Functionality: Onboard real-time fluorescence detection enables direct amplification and quantification post-extraction, eliminating inter-instrument transfer and reducing turnaround time.
• 576-Sample High-Throughput Capacity: Optimized for large-volume blood bank operations; supports flexible batching with configurable pool sizes (e.g., 1:6, 1:16, or 1:24) and simultaneous single-sample runs.
• Full Tube Handling Automation: Robotic arm performs cap opening/closing, barcode scanning, tube orientation correction, and precise liquid handling—all without operator input.
• Comprehensive Contamination Mitigation: Features HEPA-filtered laminar airflow, negative-pressure chamber zoning, UV-C irradiation cycles (254 nm), droplet capture trays, disposable waste cassettes, and aerosol-resistant pipette tips.
• GLP-Ready Audit Trail: All user actions, system events, error logs, and environmental parameters (e.g., temperature, humidity, door status) are timestamped and stored with immutable digital signatures.

Sample Compatibility & Compliance

The Aurora PANA X6 accepts primary collection tubes (EDTA-K2/K3, citrate, or CPDA-1 anticoagulated whole blood) and plasma aliquots without pre-processing. It accommodates standard 13 mm × 75 mm, 13 mm × 100 mm, and 16 mm × 100 mm tube formats. The system complies with ISO 15189:2022 requirements for medical laboratory quality and competence, and its software architecture supports 21 CFR Part 11-compliant electronic records when deployed with appropriate validation protocols. All reagent kits used with the platform are CE-IVD marked and aligned with EN ISO 13485:2016 manufacturing standards. The instrument’s negative-pressure containment design meets WHO BSL-2 recommendations for handling human-derived infectious materials.

Software & Data Management

The embedded control software provides role-based access (operator, supervisor, administrator), customizable protocol templates, and real-time dashboard visualization of run progress, error diagnostics, and consumables inventory. Raw fluorescence data, Ct values, amplification curves, and melt curve profiles are exportable in CSV, PDF, and SDM (Standard Data Format for Molecular Diagnostics) compliant files. Audit logs retain full chain-of-custody metadata—including operator ID, timestamp, instrument serial number, and calibration history—for up to 12 months. Integration with LIS/HIS systems is supported via ASTM E1384 and HL7 v2.5.1 interfaces, enabling bidirectional sample order routing and automated result reporting.

Applications

• Blood donor nucleic acid testing (NAT) for HBV, HCV, and HIV-1
• High-volume surveillance screening in regional blood centers
• Emergency response NAT deployment during outbreak scenarios
• Reference laboratory confirmation workflows requiring traceable, low-variance extraction
• Method validation studies comparing pooling strategies and extraction efficiency across sample matrices

FAQ

Does the Aurora PANA X6 require dedicated lab infrastructure beyond standard electrical and network connectivity?
Yes—it requires a dedicated bench space with stable ambient temperature (15–30 °C), relative humidity ≤70%, and connection to a Class II biological safety cabinet for initial sample loading if handling open-tube specimens prior to sealing.
Can third-party reagents be used with this system?
Only KHB-validated magnetic bead kits and qPCR master mixes are supported for regulatory-compliant operation; off-label reagents void warranty and invalidate audit trail integrity.
Is remote monitoring or troubleshooting supported?
Yes—the system includes secure TLS 1.2-enabled remote access for technical support personnel, subject to customer-configured firewall policies and multi-factor authentication.
What is the recommended maintenance schedule?
Daily cleaning of pipette tips and waste cassettes; weekly calibration of liquid handling accuracy and UV lamp intensity; biannual performance verification using KHB QC reference panels (Cat. No. PAN-QC-01/02).