Kehua Aurora Flexi96 Fully Automated Nucleic Acid Analysis System

Overview

The Kehua Aurora Flexi96 Fully Automated Nucleic Acid Analysis System is an integrated laboratory automation platform engineered for end-to-end nucleic acid processing—from primary tube loading to ready-to-run PCR plate sealing. Built upon a modular robotic architecture, the system implements a standardized, walk-away workflow compliant with clinical and research-grade molecular diagnostics requirements. It operates on a core principle of sequential, traceable liquid handling combined with real-time process monitoring and environmental control. The system supports both DNA and RNA isolation from diverse sample types—including whole blood, serum, plasma, saliva, swab eluates, and tissue homogenates—followed by precise qPCR or RT-qPCR reaction setup. Its design emphasizes reproducibility, contamination mitigation, and audit-ready operational integrity, making it suitable for high-throughput clinical laboratories, reference labs, and translational research facilities operating under GLP or ISO 15189-aligned quality frameworks.

Key Features

• Four independent positive-displacement pipetting channels with dual-sensor feedback (capacitive + pressure sensing) for real-time liquid level detection, tip presence verification, aspiration failure alerting, and clot obstruction identification.
• Programmable non-equidistant dispensing capability with minimum inter-well spacing of 9 mm—enabling flexible assay layout support including custom master mix distribution and multi-step dilution schemes.
• Precision liquid handling across 1–1000 µL range: CV ≤ 5% at 2 µL, ≤ 2.5% at 10 µL, and ≤ 0.5% at volumes ≥ 50 µL—validated per ISO 8655-6 and CLSI EP10-A3 guidelines.
• Integrated biosafety modules: HEPA-filtered laminar airflow cabinet (ISO Class 5 equivalent), UV-C germicidal irradiation (254 nm, programmable cycle timing), and motion-activated interlocked access doors with proximity sensing in extraction zones.
• Automated tube management: barcode scanning (1D/2D), cap piercing, uncapping/capping, sample pooling, vortex mixing, thermal incubation (4–95 °C), refrigerated reagent storage (4–10 °C), and magnetic bead separation via high-gradient permanent magnet arrays.

Sample Compatibility & Compliance

The Aurora Flexi96 accommodates standard SBS-format consumables—including 96-well deep-well plates, PCR plates (full-skirted and semi-skirted), 1.5 mL and 2.0 mL conical tubes, and magnetic bead-based extraction kits from major third-party vendors (e.g., QIAGEN, Thermo Fisher, Promega). All fluidic pathways are constructed from chemically resistant, low-binding polymers certified for DNase/RNase-free performance. The system meets electromagnetic compatibility (EMC) requirements per IEC 61326-1 and safety standards per IEC 61010-1. While not FDA 510(k)-cleared as an IVD device, its operational logs, user access controls, and electronic signature support align with FDA 21 CFR Part 11 readiness when deployed with validated LIMS integration.

Software & Data Management

The embedded control software provides role-based user authentication, protocol versioning, and full audit trail generation—including timestamps, operator ID, module status, error codes, and raw sensor data. Protocols are developed using a drag-and-drop graphical interface supporting conditional logic, loop structures, and parameterized variables. Raw run data (including pipette force curves, UV exposure logs, door open/close events, and temperature profiles) are exportable in CSV and XML formats. Optional API integration enables bidirectional communication with laboratory information systems (LIS) and electronic lab notebooks (ELN) via RESTful endpoints compliant with HL7 FHIR R4 standards.

Applications

• High-volume infectious disease testing (e.g., SARS-CoV-2, HIV, HBV, HCV, HPV)
• Companion diagnostics and oncology biomarker profiling (e.g., EGFR, KRAS, BRAF)
• Pharmacogenomic screening and germline variant analysis
• Microbiome metagenomic library preparation (16S rRNA, ITS sequencing)
• Quality control of biobanked specimens and cell line authentication (STR profiling)

FAQ

Does the Aurora Flexi96 support third-party nucleic acid extraction kits?

Yes—it accepts commercially available magnetic bead-based kits without hardware modification; protocol templates are provided for leading vendors.
Can the system be integrated into an existing LIS or middleware environment?

Yes—via configurable HL7 v2.x and FHIR-compliant REST API; validation documentation and interface specifications are available under NDA.
What maintenance intervals are recommended for the pipetting modules?

Calibration verification is advised every 3 months or after 500 cycles; full preventive maintenance—including HEPA filter replacement and UV lamp output validation—is scheduled annually.
Is remote monitoring or troubleshooting supported?

Yes—the system includes secure TLS-encrypted remote access capability for authorized service engineers, with granular permission controls and session logging.