• RV008 WHO EUL Listed!
    KOR
Bacterial Infections & Others Arbo Virus Respiratory Diseases Sexually Transmitted Diseases
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MOLECULAR DIAGNOSTIC KITS

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

The RADI COVID-19 Detection Kit is intended for the presumptive qualitative detection of specific nucleic acid sequences from the genome of the SARS-CoV-2 S gene and RdRP gene from the upper respiratory specimens such as Nasopharyngeal swab, Oropharyngeal swab.

Product Specification

  • RADI COVID-19 Detection Kit
    Intended use Qualitative detection of COVID-19
    Specimen type RNA extracted from Nasopharyngeal and/or Oropharyngeal swab
    Target S gene, RdRP gene
    Product
    contents    		 COVID-19 Positive Control (Red)
    COVID-19 Extraction Control (Red, Yellow sticker on top)
    3X RT MasterMix (Yellow)
    COVID-19 Primer & Probe Mixture (Brown)
    RNase Free Water (Blue)
    Shelf life 8 months
    Storage
    condition    		 -25℃ ~ -15℃

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
RV008 RADI COVID-19 Detection Kit
MP002 RADI PREP Swab and Stool DNA/RNA Kit
KM001 RADI PREP Plus

Analytical Sensitivity (Limit of Detection)

In order to determine limit of detection (LoD) of RADI COVID-19 Detection kit, a tentative LoD is determined with several diluted concentrations using synthesized RNA by in vitro transcription in 5 replicates. After fixing a tentative LoD is the claimed LoD was determined with 20 replicates of diluted concentrations spanning tentative LoD.

Final LoD of S gene : 0.66 copies/㎕

  • Final LoD of S gene : 0.66 copies/㎕

    Target copies/㎕ Mean Ct Result in
    agreement    		 Percent
    agreement
    S gene 2.33 37.29 20/20 100%
    2.00 37.35 20/20 100%
    0.66 38.24 20/20 100%
    0.5 38.27 17/20 85%

  • Final LoD of RdRP gene : 0.66 copies/㎕

    Target copies/㎕ Mean Ct Result in
    agreement    		 Percent
    agreement
    RdRP gene 2.33 36.93 20/20 100%
    2.00 37.01 20/20 100%
    0.66 38.16 20/20 100%
    0.5 38.49 16/20 80%

Cross Reactivity

RADI COVID-19 Detection Kit was tested with 63 potential microorganism (including pooled human nasal wash sample).
It was verified that 63 kinds of potential cross-reacting microorganism did not cross-react with any of 63 microorganisms.

INTERFERING SUBSTANCE

RADI COVID-19 Detection Kit was tested with 14 potentially interfering endogenous or exogenous substances in negative clinical matrix with the absence or presence of SARS-CoV-2 (3X LoD).
And it was verified that 14 kinds of potential interfering substances did not have an impact on interference.

CLINICAL PERFORMANCE

The clinical performance of RADI COVID-19 Detection Kit has been evaluated in different countries from different continents.
A total number of 764 samples have been evaluated, and 366 of them were SARS-CoV-2 positive and the rest were negative samples.

  • Performance in individual site

    No Site Result for Sensitivity Result for Specificity
    1 Switzerland 100% (50/50) 100% (100/100)
    2 USA 100% (111/111) 100% (96/96)
    3 Saudi Arabia 100% (31/31) 100% (24/24)
    4 Uganda 94% (29/31) 100% (45/45)
    5 Brazil 100% (14/14) 100% (8/8)
    6 Netherland 92% (12/13) 100% (11/11)
    7 Haiti 100% (6/6) 100% (5/5)
    8 South Korea 99% (109/110) 100% (109/109)

  • Comprehensive Performance from all sites

    Comprehensive Sensitivity% Comprehensive Specificity%
    98.9% (362/366)
    (95CI% : 97.2 – 99.6)    		 100.0% (398/398)
    (95CI% : 99.0 – 100.0)

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