Technical Information: RADI FAST Hantavirus 6-plex Detection Kit

1. Summary

The RADI FAST Hantavirus 6-plex detection kit is a high-performance real-time PCR (qPCR) solution designed for centralized laboratories and diagnostic centers.

this kit is optimized for standard laboratory workflows, offering exceptional speed and multi-target differentiation.

It provides reliable results in under 50 minutes, significantly increasing laboratory throughput compared to traditional qPCR assays that typically require over 90 minutes.

2. Performance Characteristics

  2.1 Analytical Sensitivity (Limit of Detection)

    ● Limit of Detection (LoD): 10 copies/μL validated across all 6 targets.

    ● Assay Configuration: The kit utilizes a 2-vial primer/probe system for comprehensive differentiation.

     ○ Hanta-1 Mixture: Dobrava-Belgrade (DOBV), Seoul (SEOV), and Puumala (PUUV).

     ○ Hanta-2 Mixture: Sin Nombre (SNV), Andes (ANDV), and Hantaan virus (HTNV).

    ● High Precision: Optimized for rapid cycling without compromising sensitivity, ensuring accurate detection of low-titer samples.

    ● Internal Control (IC): Continuous monitoring of the IC validates the integrity of the entire process—from nucleic acid extraction to PCR results.

  2.2 Analytical Specificity (Cross-reactivity)

   Extensive testing confirms 100% specificity with zero cross-reactivity against clinically relevant pathogens:

3. Strategic Advantages

    ● Ultra-Fast Results: Complete PCR runs in under 50 minutes, compared to the standard 90+ minutes of conventional kits.

    ● 6-Target Differentiation: Uniquely identifies 6 major Hantaviruses in a single multiplex format.

    ● Universal Compatibility: Validated for use on major qPCR platforms, including Bio-Rad CFX96, Thermo Fisher Quantastudio 5, and Applied Biosystems (ABI) 7500.

    ● High Throughput: Optimized for large-scale screening in centralized diagnostic environments.

4. Operating Specifications

5. Result Interpretation Criteria

    ● Results are determined based on the Cycle Threshold (Ct) values of the target pathogens and the Internal Control (IC).

6. Product Composition

  Each kit contains reagents for 50 tests:

    ● Mastermix: High-efficiency 1-vial mastermix.

    ● Hanta-1 Primer/Probe Mixture: Targets DOBV, SEOV, and PUUV.

    ● Hanta-2 Primer/Probe Mixture: Targets SNV, ANDV, and HTNV.

    ● Positive Control: Hantavirus positive control for result validation.

    ● RNase-free Water: Negative control

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