Anxuyuan AxiLona FL-100 Fully Automated Real-Time Fluorescent Quantitative PCR System

Overview

The Anxuyuan AxiLona FL-100 is a fully integrated, benchtop real-time fluorescent quantitative PCR system engineered for high-fidelity nucleic acid detection in resource-constrained and decentralized laboratory environments. Unlike conventional qPCR platforms requiring separate nucleic acid extraction, thermal cycling, and fluorescence readout modules, the AxiLona FL-100 implements an end-to-end closed-tube workflow within a single disposable cartridge. It employs solid-state Peltier-based thermal control with active feedback regulation to maintain precise ramping rates and uniform block temperature distribution across all four reaction chambers. Detection is achieved via multi-channel LED excitation and high-sensitivity photodiode-based fluorescence acquisition synchronized with real-time amplification kinetics. Designed specifically for syndromic testing—where clinical presentation (e.g., respiratory, gastrointestinal, or febrile illness) dictates a preconfigured panel of pathogen targets—the system delivers quantitative results without user intervention post-loading, supporting rapid triage and actionable diagnostics.

Key Features

• Fully automated sample-to-answer workflow: Integrated lysis, reverse transcription (if required), PCR amplification, and endpoint fluorescence detection within a single-use, hermetically sealed cartridge.
• Syndrome-optimized assay panels: Pre-configured multiplex assays targeting ≥30 clinically relevant nucleic acid targets per run—including DNA and RNA viruses, bacteria, and antimicrobial resistance markers—validated per CLSI EP17-A2 guidelines for limit of detection (LOD).
• High analytical sensitivity: Verified LOD range of 100–1,000 copies/mL across target analytes under standardized matrix conditions (e.g., nasopharyngeal swab in universal transport medium).
• Contamination mitigation architecture: Cartridge-integrated physical barriers, UV-decontaminated fluidic pathways, and negative-pressure air handling eliminate cross-sample aerosol carryover; meets ISO 15189 requirements for contamination control in molecular diagnostics.
• Minimal hands-on time: <5 minutes of operator interaction per run; total turnaround time ≤90 minutes from sample loading to digital result export.
• Compact footprint & low power demand: Dimensions of 320 × 280 × 240 mm; operates on standard 100–240 V AC input with peak power draw <150 W—suitable for mobile labs, primary care clinics, and field-deployable diagnostic units.

Sample Compatibility & Compliance

The AxiLona FL-100 accepts raw clinical specimens including nasopharyngeal swabs, oropharyngeal swabs, sputum, whole blood (EDTA), and bronchoalveolar lavage fluid—processed directly without prior nucleic acid purification. Cartridge chemistry incorporates internal amplification controls (IACs) and synthetic spike-in standards to monitor inhibition and assay performance per run. The system complies with IEC 61010-1 for electrical safety and IEC 61326-1 for electromagnetic compatibility. Assay cartridges are manufactured under ISO 13485-certified quality management systems and support audit-ready documentation for GLP and GMP-aligned workflows. Data integrity adheres to ALCOA+ principles, with electronic records compliant with FDA 21 CFR Part 11 when used with validated software configurations.

Software & Data Management

The embedded operating system runs Anxuyuan’s proprietary AxiOS v3.2 firmware, featuring intuitive touchscreen navigation, multilingual UI (English, Spanish, French, Arabic), and role-based access control. All amplification curves, Ct values, melting profiles (where applicable), and QC metrics are stored locally with automatic timestamping and operator ID logging. Raw data export supports CSV, PDF, and HL7 v2.5 formats for LIS/HIS integration. Audit trails record all critical events—including calibration updates, cartridge lot registration, and result modifications—with immutable hashing. Remote firmware updates and performance monitoring are supported via TLS 1.2-secured cloud connectivity (optional configuration), enabling proactive service alerts and regulatory change notifications.

Applications

• Rapid syndromic respiratory pathogen screening (e.g., influenza A/B, RSV, SARS-CoV-2, adenovirus, human metapneumovirus, rhinovirus/enterovirus, Mycoplasma pneumoniae).
• Gastrointestinal infection panels covering bacterial toxins (e.g., C. difficile tcdB), viral agents (norovirus GI/GII, rotavirus A), and parasitic markers (Cryptosporidium, Giardia).
• Febrile illness differential testing in tropical and endemic regions, including dengue NS1/RNA, chikungunya, Zika, and malaria species differentiation.
• Antimicrobial resistance gene detection (e.g., mecA, vanA/vanB, CTX-M group 1, KPC) directly from positive blood cultures or wound swabs.
• Quality assurance in biobanking and clinical trial sample stratification where rapid nucleic acid profiling is required pre-sequencing.

FAQ

What sample types are validated for use with the AxiLona FL-100?

Clinical specimens including nasopharyngeal/oropharyngeal swabs in viral transport media, sputum, EDTA whole blood, and BAL fluid have undergone full analytical validation per CLSI EP12-A2 and EP17-A2.
Does the system support custom assay development?

Yes—Anxuyuan provides a validated cartridge development kit (CDK) and technical support for LDT implementation under local regulatory frameworks; custom panels require formal verification per ISO 15189 Annex A.4.
How is temperature uniformity verified across the 4-channel block?

Each production unit undergoes thermal mapping using NIST-traceable PT100 sensors at 9 spatial points per channel; deviation across all positions remains ≤±0.3°C at 60°C and 95°C setpoints.
Is the instrument compatible with existing laboratory information systems?

HL7 v2.5 ADT and ORU message support is built-in; API documentation and interface engine configuration guides are provided for seamless LIS/HIS integration.
What maintenance is required for long-term operational reliability?

No routine optical alignment or fluidic servicing is needed; annual calibration verification using Anxuyuan-certified reference cartridges is recommended and documented in the electronic maintenance log.