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COVID-19 Products

RADI COVID-19 Detection Kit(REF: RV008)

FAST RESULT, EASY TO USE and COMPACT !
Get the result within 80 min for all suspected cases for 2019 novel coronavirus!

Introduction

RADI COVID-19 Detection Kit is used for qualitative detection of 2019 novel coronavirus in
human Nasal Swab or Sputum by using ABI 7500, Bio-Rad CFX 96 Platform, etc.

Product Specification

  • RADI COVID-19 Detection Kit
    Intended use Qualitative detection of COVID-19
    Specimen type RNA extracted in nasal swab or Sputum
    Target RdRP, S
    Product
    contents    		 3X RT MasterMix (Yellow)
    COVID-19 Primer & Probe Mixture (Brown) COVID-19 positive control (Red)
    RNase free water (Blue)
    COVID-19 Extraction Control (Red,Yellow sticker on top)
    LoD 0.66 copies/㎕
    Storage
    condition    		 -15 ℃ ~ -25 ℃

Test Procedure

  • Nucleic acid
    extraction
    RADI PREP Swab and Stool DNA/RNA Kit(KH Medical)
    QIAamp DSP Viral RNA Mini Kit(Qiagen)
    QIAamp Viral RNA Mini Kit (Qiagen)
  • Make Mixture

    * Simplified Procedure when make mixture
    (Number of tubes minimized)!

  • Real-time
    PCR Run
    CFX96(BioRad)
    ABI7500(ThermoFisher)
    Rotor-Gene Q (Qiagen)
    LightCycler 480(Roche)
  • Analysis

Ordering Information

KHMedical Ref Product Name Shelf Life
RV008 RADI COVID-19 Detection Kit 8 months
MP002 RADI PREP Swab and Stool DNA/RNA Kit 18 months

Analytical Sensitivity (Limit of Detection)

To test the Sensitivity and Limit of Detection(LoD) of RADI COVID-19 Detection Kit, synthesized RNA by
in vitro transcription was diluted to 4 concentrations and ran 24 times for each.

LOD IS 0.66 COPIES/㎕

  • Target Copies/㎕ Mean Ct Result in
    agreement    		 Percent
    agreement
    S gene 1.66 37.62 24/24 100%
    0.66 39.88 23/24 95.83%
    0.5 40.18 24/24 100%
    0.33 39.57 20/24 83.32%
  • RdRP gene Copies/㎕ Mean Ct Result in
    agreement    		 Percent
    agreement
    S gene 1.66 36.55 24/24 100%
    0.66 38.06 23/24 95.83%
    0.5 39.08 24/24 91.66%
    0.33 38.47 21/24 87.49%

    * IPC mean Ct : 22.93

Cross Reactivity

RADI COVID-19 Detection KIT did not cross-react with any of 53 pathogens.

Comparative Evaluation by using WHO published Primer & Probe

RADI COVID-19 Detection Kit’s Primer & Probe design could detect up to 10 copies/rxn compared to
WHO Primer & Probe which detect up to 10² copies/rxn for E gene and 10³ copies/rxn for RdRP gene

  • RADI COVID-19 Detection KIT
    Copies / rxn S gene RdRP gene
    106 21.06 21.2 21.46 21.63
    105 25.05 24.97 25.01 24.65
    104 28.99 29.22 28.22 28.29
    103 32.47 32.62 31.96 31.81
    102 36.51 36.41 36.4 35.18
    101 39.95 39.66 39.18 38.05
  • WHO primer & probe
    E gene RdRP gene
    23.24 22.72 24.75 24.78
    26.48 26.34 28.17 28.12
    29.90 29.88 31.44 31.31
    32.48 32.26 34.61 33.72
    35.69 36.76 N/A N/A
    N/A N/A N/A N/A

Test Performance

RADI COVID-19 DETECTION KIT

  • S gene

  • RdRP gene

WHO PRIMER & PROBE

  • E gene

  • RdRP gene