CoVClear Mutation Panel

CoVClear Mutation Panel

The MiRXES CoVClear Mutation Panel is a real-time RT-PCR assay for the qualitative detection of key mutations in the receptor-binding domain (RBD) of the spike protein of the SARS-CoV-2 virus (E484K and L452R) from nasal specimens confirmed to be positive for SARS-CoV-2 by RT-PCR.

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This tool can be used to identify COVID-19 positive patients who may have been infected by SARS-CoV-2 variants of concern (VOC), such as the Beta (B.1.351 – South Africa) lineage or Delta (B.1.167.2 – India) lineage.

*Research Use Only

Key Features

Detects key SARS-CoV-2 variants

Individual panels to detect key mutations for identification of key variants of concern and variants of interest identified by the WHO.

Fast results

Can be used for quick identification of COVID-19 positive patients who may be infected by variants of concern or interest before sequencing.


High sensitivity and specificity. Limit of detection at 2-3 copies per microliter. Uses N gene as internal control for COVID-19 diagnosis validation

Lab ready

Compatible with current industry-standard RT-PCR instruments and data analysis software without any additional installations.

Quality assured

Manufactured and distributed under ISO13485 quality management system.

SARS-CoV-2 Variants Description

The World Health Organization (WHO) has defined a SARS-CoV-2 isolate as a variant of interest (VOI) if it is phenotypically changed compared to a reference isolate of has a genome with mutations that lead to amino acid changes associated with established or suspected phenotypic implications; AND has been identified to cause community transmission/multiple COVID-19 cases/clusters, or has been detected in multiple countries.

A VOI is further classified as a variant of concern (VOC) if, through a comparative assessment, it has been demonstrated to be associated with:

  • Increase in transmissibility of detrimental change in COVID-19 epidemiology;
  • Increase in virulence or change in clinical disease presentation; or
  • Decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics.

WHO-designated variants of concern (VOCs) and selected variants of interest (VOIs), as of 4 August 2021.


WHO Label Pango Lineage First identified Mutation Panel Targets Other spike protein substitutions
Delta B.1.617.2 India L452R D614G, P681R
Beta B.1.351 South Africa E484K D80A, D215G, 241/243del, K417N, N501Y, D614G, A701V
Gamma P.1 Brazil E484K L18F, T20N, P26S, D138Y, R190S, K417T, N501Y, D614G, H655Y, T1027I, V1176F
Eta B.1.525 Multiple countries E484K Q52R, A67V, 69/70del, 144del, D614G, Q677H, F888L
Epsilon B.1.427/B.1.429 USA, California L452R S13I, W152C, D614G


Ordering Information

Product Pack Size Contents Catalogue No.
CoVClear Mutation Panel Reagent Pack 200 tests/kit Reaction Master Mix, Enzyme Mix, Positive Control (WT+N), Negative Control FGS0032R
CoVClear Mutation Panel E484K 200 tests/kit Primer-Probe Mix (E484K+N), Positive Control (E484K+N) FGS0035R
CoVClear Mutation Panel L452R 200 tests/kit Primer-Probe Mix (L452R+N), Positive Control (L452+N) FGS0036R

Research Use Only (RUO).