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MOLECULAR DIAGNOSTIC KITS

RADI Flu-SC2 Detection Kit(REF: RV009)

FAST RESULT AND EASY TO USE !
Get the result within 100 min for all suspected cases for
Influenza A and/or Influenza B and/or SARS-CoV-2 (COVID-19)!

Introduction

The RADI Flu-SC2 Detection Kit is based on Real-time RT-PCR technology utilizing
reverse-transcriptase(RT) reaction to convert RNA into complementary DNA (cDNA).
It is intended for the presumptive qualitative detection of nucleic acid from the Influenza A virus and/or
Influenza B virus and/or SARS-CoV-2 in Upper respiratory specimens such as Nasopharyngeal swab, Oropharyngeal swab.
The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.

Product Specification

  • RADI Flu-SC2 Detection Kit
    Intended use Qualitative detection of Influenza A and/or Influenza B and/or SARS-CoV-2 (COVID-19)
    Specimen type RNA extracted in Nasopharyngeal swab, Oropharyngeal swab
    Target Influenza A (H1, H1N1pdm09, H3), Influenza B (Yamagata, Victoria), SARS-CoV-2 (S, RdRp)
    LoD (copies/㎕)
    Influenza A
    H1 H1N1pdm09 H3
    3.02 3.16 0.95
    Influenza B SARS-CoV-2
    Yamagata Vitoria S, RdRp
    0.35 0.26 0.33
    Product
    contents    		 Flu-SC2 Primer & Probe Mixture (Brown)
    3X RT MasterMix (Yellow)
    Flu-SC2 positive control (Red)
    RNase free water (Blue)
    Flu-SC2 Internal control (Red, yellow sticker) IFU
    Storage
    condition    		 -25 ℃ ~ -15 ℃
    Shelf life 6 months
    PCR
    Instrument    		 CFX96 (Bio-Rad)

Test Procedure

  • Nucleic acid
    extraction
  • 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

Analytical Sensitivity (Limit of Detection)

To test the sensitivity and limit of detection (LoD) of RADI Flu-SC2 Detection kit,
all sample replicates were prepared by spiking the reference virus subtype RNA material into negative clinical swab matrix.

Target Influenza A Influenza B SARS-CoV-2
Subtype H1 H1N1pdm09 H3 Yamagata Victoria S, RdRp
LoD (copies/㎕) 3.02 3.16 0.95 0.35 0.26 0.33
Cut-off Ct value 38.00 Ct 38.00 Ct 38.00 Ct

Cross Reactivity

RADI Flu-SC2 Detection Kit did not cross-react with any of 63 pathogens except Influenza A, Influenza B, SARS-CoV-2.

Interfering substance

RADI Flu-SC2 Detection Kit did not interference for the interfering substance list below.

  • NO. Substance Concentration
    1 Whole blood 10%
    2 Human genomic RNA 303.5ug/mL
    3 Nasal spray 10%
    4 Nasa gel 5%
    5 Nasal ointment 10%
    6 Triamcinolone 2ug/mL
  • NO. Substance Concentration
    7 Benzocaine 1mg/mL
    8 Levofloxacin 10ug/mL
    9 Oseltamivir phosphate 2mg/mL
    10 Mucin type I-S 100ug/mL
    11 Biotin 200ug/mL

Precision (Repeatability, Reproducibility)

Precision of RADI Flu-SC2 Detection Kit is SD ≤ 0.9, SD ≤ 2.05%.

Ordering Information

Category Product Name Size Cat. No.
PCR Kit RADI Flu-SC2 Detection Kit 100 tests/Kit RV009
Extraction Kit RADI Prep swab and stool DNA/RNA Kit 100 tests/Kit MP002
RADI Prep Plus swab and stool DNA/RNA Kit 100 tests/Kit AP006
Instrument RADI PREP PLUS KM001
RADI PCR96 OE004