Infectious Diseases

Tested and proven testing solutions

COVID-19

MiRXES offers complete COVID-19 testing solutions, starting from sample collection and preservation, through easy and reliable RNA extraction, to tested and proven SARS-CoV-2 RT-PCR diagnostic tests and mutation panels for quick identification of key variants.

Ordering Information

Sample Collection & Processing Solutions

Swab Collection System

Collect, handle, and store nasal and throat swab samples safely and stably (up to two weeks at room temperature).

Saliva Collection Kit

Easy and convenient collection of saliva samples which can be transported and stored stably up to 15 days at room temperature.

RNA Extraction Kits

MAGec RNA Extraction Kits for easy and reliable RNA extraction using guanidine-based lysis and magnetic bead-based isolation.

RNA Extraction Instruments

Automated extraction system optimized for MAGec RNA Extraction Kits. Suitable for medium- and high-throughput workflows.

RT-PCR Testing
Solutions

Fortitude 2.1 Test Kit

Tested and proven RT-PCR test detecting 2 SARS-CoV-2 ORF regions. More than 7 million tests deployed in over 45 countries.

Fortitude 3.0 Test Kit

Updated Fortitude COVID-19 RT-PCR test detecting 2 SARS-CoV-2 genes (ORF and N). Able to detect all variants of concern.

Fortitude Syndromic Panel

Fortitude SARS-CoV-2 & Flu A/B test kit. Detects 2 SARS-CoV-2 genes (ORF and N).

CoVClear Mutation Panel

RUO test to detect key SARS-CoV-2 mutations for early identification of COVID-19 positive patients infected by variants of concern.

November 2021 Update: SARS-CoV-2 Variants

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 SARS-CoV-2 variants of concern (VOCs), as of 29 November 2021.

WHO Label
Pango Lineage
First identified
Spike protein substitutions
Alpha
B.1.1.7
United Kingdom
N501Y, 69del, 70del, 144del, (E484K*), (S494P*), N501Y, A570D, D614G, P681H, T716I, S982A, D1118H (K1191N*)
Beta
B.1.351
South Africa
D80A, D215G, 241del, 242del, 243del, K417N, E484K, N501Y, D614G, A701V
Gamma
P.1
Brazil
L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, D614G, H655Y, T1027I
Delta
B.1.617.2
India
T19R, (V70F*), T95I, G142D, E156-, F157-, R158G, (A222V*), (W258L*), (K417N*), L452R, T478K, D614G, P681R, D950N
Omicron
B.1.1.529
South Africa

WHO-designated SARS-CoV-2 variants of interest (VOIs), as of 29 November 2021.

WHO Label
Pango Lineage
First identified
Spike protein substitutions
Epsilon
B.1.427
US (California)
L452R, D614G
Epsilon
B.1.429
US (California)
S13I, W152C, L452R, D614G
Eta
B.1.525
UK/Nigeria
A67V, 69del, 70del, 144del, E484K, D614G, Q677H, F888L
Iota
B.1.526
US (New York)
L5F, (D80G*), T95I, (Y144-*), (F157S*), D253G, (L452R*), (S477N*), E484K, D614G, A701V, (T859N*), (D950H*), (Q957R*)
Kappa
B.1.617.1
India
(T95I), G142D, E154K, L452R, E484Q, D614G, P681R, Q1071H
None
B.1.617.3
India
T19R, G142D, L452R, E484Q, D614G, P681R, D950N
Lambda
C.37
Peru
G75V, T76I, 246-252del, L452Q, F490S, D614G, T859N
Mu
B.1.621
Colombia
E484K, N501Y, P681H

Detection of key SARS-CoV-2 variants by MiRXES RT-PCR test kits

The MiRXES R&D team is constantly tracking the World Health Organization’s designation of new VOCs and VOIs and has performed in silico analyses to determine the sequence homology between the MiRXES SARS-CoV2 RT-PCR primers and all SARS-CoV-2 sequences, including those of specific variants.

Overall, >99.4% of aligned sequences have 100% homology to either the ORF or N gene target sequence of MiRXES RT-PCR test kits.

Percentage of aligned sequences in the GISAID database that have 100% homology to the primer (probe) sequence of the MiRXES RT-PCR test kits, as of 29 November 2021:

Sequence homology with
Fortitude 2.1
Fortitude Syndromic Panel
All SARS-CoV-2 ORF target sequences
99.4
97.6
All SARS-CoV-2 N gene target sequences
98.1
Delta (B.1.617.2)
100.00
99.90
Alpha (B.1.1.7)
99.79
99.99
Beta (B.1.351)
100.00
99.96
Gamma (P.1)
99.98
99.98
Omicron (B.1.1.529)
100.00
100.00
Lambda (C.37)
100.00
99.66
Mu (B.1.621)
100.00
100.00
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