Technical Information: RADIONE Hantavirus Detection Kit

1. Summary

The RADIONE Hantavirus Detection Kit is a state-of-the-art, all-in-one Point-of-Care (POC) solution designed for the rapid identification of Hantavirus infections.

By integrating automated nucleic acid extraction and real-time PCR into a single streamlined workflow, the system delivers laboratory-grade accuracy within 60 minutes,

making it ideal for both clinical laboratories and field-based diagnostic settings

2. Performance Characteristics

2.1 Analytical Sensitivity (Limit of Detection)

  ● Limit of Detection (LoD): 1,000 copies/mL validated across all 6 targets

  ● Target Configuration:

    ○ Well A: Dobrava-Belgrade (DOBV), Seoul (SEOV), and Puumala (PUUV)

    ○ Well B: Hantaan (HTNV), Andes (ANDV), and Sin Nombre virus (SNV)

  ● Consistent Performance: All targets exhibit stable Cycle Threshold (Ct) values ranging between 34 and 37, ensuring robust detection even at lower concentrations

● Quality Assurance: Continuous monitoring of the Internal Control (IC) validates the integrity of the entire process—from extraction to result

2.2 Analytical Specificity (Cross-reactivity)

  The assay ensures maximum diagnostic precision with proven zero cross-reactivity against 12 potential cross-reactants

  The RADIONE platform is designed with future diagnostic value in mind, supporting high-throughput multiplexing

  ● Well Expansion: The RADIONE 4ch platform supports the simultaneous use of Wells A, B, C, and D

  ● Comprehensive Panels: Each well can detect up to 3 unique targets, allowing for a 12-target multiplex panel in a single run

  ● Co-Diagnosis: This scalability allows for panels that diagnose Hantavirus alongside clinically similar diseases (e.g., Leptospira, O. tsutsugamushi, and SFTSV) for rapid differential diagnosis.

4. Intelligent PCR Data Analysis

  The system provides both high-quality amplification data and intelligent automated analysis to reduce clinical burden

  ● Instant P/N Result Display: Software automatically analyzes curves and displays results as "P" (Positive) or "N" (Negative) 

  ● Elimination of Bias: Automated qualitative analysis prevents human error and ensures consistency regardless of user expertise

  ● Real-time Monitoring: Users can still view Ct values and amplification curves for secondary verification during the run

5. Simplified 3-Step Workflow

  Designed for ease of use in any medical setting with minimal hands-on time

  ● Step 1: Attach pre-filled PCR tube and remove sealing film

  ● Step 2: Add 200 μL specimen (Serum/Plasma) and load the cartridge

  ● Step 3: Run the system and receive automated results within 60 minutes

6. Strategic Advantages

  ● All-in-One Automation: Integrates magnetic rod-based extraction within the PCR cycle, eliminating separate equipment

  ● User-Centric Design: Pre-filled reagent tubes prevent contamination and human error

  ● Field-Ready Portability: The compact, 7.4 kg design is optimized for mobile clinics and remote diagnostic sitesDesigned for ease of use in any medical setting with minimal hands-on time

7. Operating Specifications