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Tested and Proven COVID-19 Testing Solutions

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.

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 5 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.

May 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.

Selected WHO-designated SARS-CoV-2 VOCs and selected VOIs, as of 1 June 2021.

Lineage
VOC/VOI
First detected in
Characteristic spike mutations
B.1.1.7 (Alpha)
VOC
United Kingdom
N501Y, 69/70del, 144del, A570D, D614G, P681H, T716I, S982A, D1118H
B.1.351 (Beta)
VOC
South Africa
E484K, N501Y, D80A, D215G, 241/243del, K417N, D614G, A701V
P.1 (Gamma)
VOC
Brazil
E484K, N501Y, L18F, T20N, P26S, D138Y, R190S, K417T, D614G, H655Y, T1027I, V1176F
B.1.617 (Delta/Kappa)
VOC
India
L452R, D614G, P681R
B.1.525 (Eta)
VOI
Multiple countries
E484K, Q52R, A67V, 69/70del, 144del, D614G, Q677H, F888L
B.1.427/B.1.429 (Epsilon)
VOI
USA, California
L452R, S13I, W152C, D614G

Detection of key SARS-CoV-2 variants by Fortitude 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 Fortitude SARS-CoV2 RT-PCR primers and all SARS-CoV-2 sequences, including those of specific variants.

This table shows the percentage of aligned sequences in the GISAID database that have 100% homology to the primer (probe) sequence of the MiRXES Fortitude series RT-PCR test kits, as of 10 May 2021:

Overall, >99% of aligned sequences have 100% homology to either the ORF or N gene target sequence of MiRXES Fortitude RT-PCR test kits.

Sequence homology with
Fortitude 2.1
Fortitude 3.0
Fortitude Syndromic Panel
All SARS-CoV-2 ORF target sequences
99.63
99.6
97.9
All SARS-CoV-2 N gene target sequences
93.5
98.7
B.1.1.7 lineage (UK)
99.19
100
99.99
B.1.351 lineage (South Africa)
100
100
100
B.1.1.28.1 (P1) lineage (Brazil)
100
100
99.98
B.1.617 lineage (India)
99.97
100
100
B.1.617.2 sub-lineage (India)
99.93
100
100
B.1.525 lineage (Multiple countries)
100
100
100
B.1.427 (USA)
100
100
100
B.1.429 (USA)
100
100
99.99