AccuPower® SARS-CoV-2 Multiplex Real-Time RT-PCR Kit (USA EUA only)

AccuPower®SARS-CoV-2 Multiplex Real-Time RT-PCR Kit is an in vitro diagnostic kit that helps diagnose COVID-19 infections. The kit is able to detect 3 targets(E gene, RdRp & N gene) in a tube. Sputum, nasopharyngeal swab, oropharyngeal swab from suspected infection patient’s sample can be used.

Inquire
Cat. No.
SCVM-2112 (100 tests/kit) / SCVM-2132 (400 tests/kit)

Note. 

The test has been validated but FDA’s independent review of this validation is pending.
Once the product is authorized by the US FDA under an emergency use authorization, the status on availability of the product will be updated on the website.

  1. This kit is 3-in-1 multiplex kit. The targets are E gene, RdRp gene and N gene.
  2. This kit is Mastermix type kit. If you want Premix type kit(non USA EUA) for ExiStation™ series, please click here.
  3. If you have any inquiry about COVID-19 diagnostic kit, please mail to sales@bioneer.com 

Features

  1. Easy use multiplex kit: Decreased hands-on steps due to 3-target multiplex detection in a tube.
  2. More accurate SARS-CoV-2 Detection: 1 target for pancoronavirus screening (E gene) and 2 targets for COVID19 confirmation (RdRp / N gene).
  3. Enhanced Sensitivity & Specificity: Bioneer’s proprietary Dual-HotStart technology accomplishes high sensitivity and specificity.
  4. High Quality: All diagnostic kits manufactured by Bioneer are under strict quality control guidelines (ISO 13485 & KGMP).
  5. Compatible with various system: Exicycler™ 96(BIONEER), Exicycler™ 384(BIONEER), CFX 96(Bio-rad), ABI7500Fast(Thermofisher), Quantstudio 5(Thermofisher)



Workflow

workflow


Specifications

  • Kit type: Mastermix type
  • Specimen type: Sputum, Nasopharyngeal swab, Oropharyngeal swab
  • Compatible thermocycler: Exicycler™ 96, Exicycler™ 384, CFX96, ABI7500FAST, Quantstudio 5

Components

SCVM-2112 (100 tests/kit)

SCV-2132 (400 tests/kit)

 Master mix (amber tube) 520ul/tube x 1ea 1,050ul/tube x 2ea
Enzyme mix (red cap)  520ul/tube x 1ea 1,050ul/tube x 2ea
Positive Control (Blue cap) 150ul/tube x 1ea 600ul/tube x 1ea
IPC (Green cap) 520ul/tube x 1ea 1,050ul/tube x 1ea
NTC (Clear cap) 150ul/tube x 1ea 600ul/tube x 1ea



Performance

1. Limit of Detection (LoD)

     - E gene (pancoronavirus screening) : 6 copies / ul
     - RdRp / N gene (SARS-CoV-2 confirmation): 2 copies / ul


2. Clinical Evaluation 

  • Comparison with reference kit (Nasopharyngeal Swab)
         - Samples: 33 positive samples, 46 negative samples
         - Results

Reference kit

Positive (n=33) Negative (n=46)
AccuPower®
SARS-CoV-2 Multiplex
Real-Time RT-PCR Kit
Positive (n=33) 33 0
Negative (n=46) 0 46
Positive percent agreement= 100 % (95% CI 89.57 – 100%)
Negative percent agreement= 100 % (95% CI 92.29– 100%)



  • Comparison with reference kitSputum
         - Samples: 32 positive samples, 41 negative samples
         - Results

Reference kit

Positive (n=32) Negative (n=41)
AccuPower®
SARS-CoV-2 Multiplex
Real-Time RT-PCR Kit
Positive (n=32) 32 0
Negative (n=41) 0 41

Positive percent agreement= 100 % (95% CI 89.28 – 100%)

Negative percent agreement= 100 % (95% CI 91.43– 100%)


  • Comparison between samples
         - Samples: 26 different sample types (NP swap / sputum) collected from the same patients
         - Results

Nasopharyngeal Swab

Positive (n=26) Negative (n=0)
Sputum Positive (n=26) 26 0
Negative (n=0) 0 0
Positive percent agreement= 100 % (95% CI 87.13– 100%)




Ordering Information

Cat. No. Product Description
SCVM-2112  AccuPower® SARS-CoV-2 Multiplex Real-Time RT-PCR Kit (100 tests)
SCVM-2132  AccuPower® SARS-CoV-2 Multiplex Real-Time RT-PCR Kit (400 tests)

Related Products

1. Real-Time PCR Kit for COVID-19 diagnosis (E gene & RdRp gene)
Cat. No. MDx Diagnostic Kit
SCV-2122  AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit (50 tests)
SCV-2112  AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit (100 tests)
NCV-1111  AccuPower® COVID-19 Real-Time RT-PCR Kit (48 tests)

2-1. Nucleic Acid Extraction (Automatic extraction)
Cat. No. Nucleic Acid Extraction Kit
K-4471  ExiPrep™Dx Viral DNA/RNA Kit
K-4571  ExiPrep™ 48 Viral DNA/RNA Kit
K-4614  ExiPrep™ 96 Viral DNA/RNA Kit
Cat. No. Instrument
A-5050  ExiPrep™16Dx
A-5150  ExiPrep™48Dx
A-5250  ExiPrep™96 Lite

2-2. Nucleic Acid Extraction (Manual extraction)

Cat. No. Nucleic Acid Extraction Kit
K-3617  MagListo™ Viral DNA/RNA Extraction Kit
K-3033M  AccuPrep® Dx Viral RNA Extraction Kit
Cat. No. Related Products
TM-1020  MagListo™ Magnetic Separation Rack

Quality Assurance

Bioneer is the holder of Quality Management System Certificates for the following standards.

ISO 13485 - certificate



Contact Us

Please contact order and marketing request via e-mail.

E-mail : sales@bioneer.com

v1.0 / 2020-06-17

Copyright© 2020 BIONEER CORPORATION. All rights reserved.