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[RV021] KH Medical Launches New RADI FAST Hantavirus 6-plex Detection Kit

admin 2026-05-14 18:00 조회수 아이콘 14

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:

Category
Tested Pathogens (Negative Result)
Differential Diagnosis
Leptospira interrogans, Orientia tsutsugamushi, SFTSV
Hemorrhagic Fevers
Dengue, Zika, Yellow fever virus
Respiratory Viruses
Influenza A/B, Adenovirus


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

Specimen Type
Serum, Plasma
Specimen Volume
200 μL
Storage Condition
-25°C to -15°C
Shelf Life
24 months


5. Result Interpretation Criteria

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


Target Pathogen (Ct ≤ 40)
Internal Control (IC)
Result
Action / Interpretation
Detected
+/- (Any)
Positive
Hantavirus detected. IC result is ignored.
Not Detected
Detected
Negative
Target not detected. Valid run.
Not Detected
Not Detected
Invalid
Test failed. Re-test from extraction.
Multiple Detected
+/- (Any)
Invalid
Likely contamination. Re-test required.


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