kogenebiotech

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Kogene provides a powerful solution
for a molecular diagnostics

SARS-CoV-2

PowerChek™ SARS-CoV-2 S-gene Mutation Detection Kit

CE-IVD

1. Pentaplex assay in a single tube : SARS-CoV-2, N501Y, E484K, K417N, IC

2. Preliminary screening for new SARS-CoV-2 variants with one test
- B.1.1.7(α), B.1.351 (β), P.1 (γ), and other variants

3. One-step Multiplex Real-time RT-PCR assay

4. Validated System : PowerAmp96™ Dx, CFX96, ABI 7500 Standard, ABI 7500 Fast, QuantStudio 5
(※ If your PCR instrument is not listed, please contact us directly.)

* RBD : Receptor-Binding Domain

The importance of SARS-CoV-2 variants surveillance

  • The SARS-CoV-2 variants can not only interrupt the formation of herd immunity through vaccination, but also the prevention and efficacy of the medical treatment.
  • It is essential that we monitor SARS-CoV-2 variants in order to prevent further spread of COVID-19 and construct the effective quarantine measures.
  • Preliminary screening for new SARS-CoV-2 variants of VOCs and VOIs ※ The variants are classified by the US CDC
    (update : June 15, 2021).
    - B.1.1.7(Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.525 (Eta), P.2 (Zeta) and etc.

To detect the mutation of RBD in S-gene

  • The spike protein (S-protein) of SARS-CoV-2 plays a crucial role in recognizing the receptor, attaching the host cell, and penetrating into the body.
  • Therefore, monitoring the mutation of receptor binding domain (RBD) in the S-gene, S-protein coding gene is at utmost importance.
  • The Kit is designed to detect the N501Y, E484K, and K417N of RBD in the S gene.

Variant lineage according to the RBD mutation

Variant lineage WHO label SARS-CoV-2 N501Y E484K K417N IC
SARS-CoV-2 - + - - - +/-
B.1.1.7 Alpha + + - - +/-
B.1.351 Beta + + + - +/-
P.1 Gamma + + + + +/-
B.1.525 / P.2 Eta / Zeta + - + - +/-

Testing procedure for SARS-CoV-2 and Variant lineage

[Reference] Variant classifications

  • VOI (Variant of Interest) << VOC (Variant of Concern) << VOHC (Variant of High Consequence)
Classification Variant lineage WHO label Attributes
Severity Infectivity Effects for vaccination and treatment Immunity
- SARS-CoV-2 SARS-CoV-2 - - - -
VOCs B.1.1.7 Alpha Increased ▲ Increased ▲ Reduced ▼ Suppression ▼
B.1.351 Beta - -
P.1 Gamma
VOIs B.1.525 Eta
P.2 Zeta
  • Reference : WHO, CDC, FDA, NIH and etc

Components

  • Primer/Probe Mix
  • 2X RT-PCR Master Mix
  • Control
  • Kit Manual