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Tested and Proven Solutions for COVID-19 Testing

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.

Sample Collection and Preservation Solutions

MiRXES Swab Collection Kits

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

RNA Extraction Solutions

MAGec RNA Extraction Kits

Easy and reliable RNA extraction using guanidine-based lysis and magnetic bead-based isolation.

MAGec Automated Extraction Systems

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

GoliPure RNA Extraction Kits

Enables non-dilutive pooling of samples for mass testing without compromising sensitivity. Optimized for automated high-throughput extraction workflows.

RT-PCR Testing Solutions

Fortitude Kit 2.1 SARS-CoV-2 Test

Tested and proven COVID-19 RT-PCR test. Deployed in over 45 countries worldwide.

Fortitude Syndromic Panels

Launching end Oct 2020.

Syndromic testing for SARS-CoV-2, Flu A, Flu B, and other viruses causing flu-like syndrome.

Fortitude Kit 2.1

SARS-CoV-2 real-time RT-PCR Test

Catalog No: 4480002 (IVD), 4480002R (RUO)

200 tests per kit

MiRXES Fortitude Kit 2.1 is is a multiplex real-time PCR assay targeting the conserved regions ORF1ab region 1 (FAM) and ORF1ab region 2 (HEX) coupled with an internal spike-in plasmid control

Limit of detection (LoD): 10 copies per reaction

No cross-reactivity with:

  • SARS-CoV-1 (SARS, identified in 2003)
  • Influenza A H1N1
  • Influenza A H3N2
  • Influenza B
  • MERS-CoV or EMC/2012 (MERS, identified in 2012)

Compatible with these real-time PCR systems:

  • Bio-Rad CFX
  • Applied Biosystems 7500
  • Applied Biosystems QuantStudio 5
  • Roche LightCycler 480

Fortitude Kit 2.1 Regulatory Approval Status and Tests Shipped

Region
Country
Regulatory Body
Status
Tests Shipped
Asia Pacific
Singapore
HSA
Approved *
2,777,600
Asia Pacific
Indonesia
MOH RI
Pending Submission
620,000
Asia Pacific
India
CDSCO
Pending Submission
100,600
Americas
Panama
Minsa
Approved *
95,600
Americas
USA
FDA
Pending Submission
87,600
Asia Pacific
Philippines
PH FDA
Approved *
77,200
Europe
EU
CE IVDR
Approved *
30,000
Americas
Peru
DIGEMID
Approved
10,000
Americas
Colombia
INVIMA
Approved *
1,200
Americas
Guatemala
MPHSW
Pending Approval *
1,200
Americas
Mexico
COFEPRIS
Pending Submission
1,000
Asia Pacific
Japan
PMDA
Pending Submission
800
Middle East
Saudi Arabia
SFDA
Pending Approval
600
Americas
Honduras
DGRS
Approved
Americas
Ecuador
MSP
Pending Approval
Asia Pacific
Australia
TGA
Pending Submission
Americas
Argentina
ANMAT
Pending Submission
Americas
Brazil
ANVISA
Pending Submission
Americas
Canada
Health Canada
Pending Submission
Americas
Paraguay
MSPBS
Pending Submission
Europe
Spain
AEMPS
Pending Submission
Asia Pacific
Vietnam
DMEHW
Pending Submission

* Previous version of the test kit, Fortitude Kit 2.0E, had already been approved.

More than 5 million Fortitude COVID-19 tests have been shipped to 13 hospitals and clinical labs in Singapore, and to more than 45 countries worldwide. Fortitude Kit 2.1 has received CE Mark and regulatory approval in Singapore, Philippines, Panama, Peru, Colombia, and Honduras.

For enquiries about ordering Fortitude Kit, contact MiRXES through email at fortitude@mirxes.com.

Swab Collection System

The MiRXES Swab Collection system allows collection of potentially viral-infected throat or nasal swabs in a guanidine solution that lyses and denatures viruses, allowing for safe storage and handling for up to two weeks at room temperature.

Lysed extract is compatible with widely available spin column- and magnetic bead-based RNA extraction kits.

Figure above shows SARS-CoV-2 viral RNA detection after extended storage in MiRXES VTM versus a comparator (Supplier C VTM). Lower Ct is indicative of more sensitive detection of viral RNA.

Ordering Information

All MiRXES swab collection kits contain collection tubes, preservation solution and virus transport medium (VTM). 

Kits are available in multiple formats to include either a throat swab, nasal swab or no swab.

Email fortitude@mirxes.com to order

Cat No.
Pack Size
Product Description
SP-A
100 tubes/pack
Swab Collection System, 1 ml Preservation Solution in 2 ml tube
SP-A-1
100 tubes/pack
Swab Collection System, 1 ml Preservation Solution in 2 ml tube, throat swab
SP-B
100 tubes/pack
Swab Collection System, 2 ml Preservation Solution in 5 ml tube
SP-B-1
100 tubes/pack
Swab Collection System, 2 ml Preservation Solution in 5 ml tube, nasal swab
SP-C
100 tubes/pack
Swab Collection System, 2.5 ml Preservation Solution in 10 ml tube
SP-C-1
100 tubes/pack
Swab Collection System, 2.5 ml Preservation Solution in 10 ml tube, throat swab
SP-C-2
100 tubes/pack
Swab Collection System, 2.5 ml Preservation Solution in 10 ml tube, nasal swab

MAGec Kits

Nucleic Acid Extraction and Purification Kits

MAGec 32 Viral RNA Extraction Kit

Catalog No: FGS0001

2 x 16 reactions per kit

MAGec 96 Viral RNA Extraction Kit

Catalog No: TBC

6 x 16 reactions per kit

MiRXES MAGec RNA Extraction Kits use guanidine-based lysis and magnetic bead-based isolation to extract viral RNA from samples.

  • Extracts RNA in less than 45 minutes.
  • Can be used with manual and automated protocols.
  • Gives high-quality purified RNA ready for downstream molecular analysis.
  • Compatible with different sample preservation solutions and universal virus transport medium.
  • Compatible with common automated extraction systems.

MAGec Instruments

Automated Nucleic Acid Extraction Instruments

MiRXES MAGec 32 and MAGec 96 Instruments are optimized to work with the MiRXES MAGec 32/96 Viral RNA Extraction Kits for integrated RNA extraction workflows.

  • Instruments enable automated RNA extraction in less than 45 minutes.
  • Hands-off operation for medium-throughput (32 sample) or high-throughput (96 sample) RNA extraction.
  • Compatible for use with other magnetic bead-based RNA extraction kits.
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COVID-19 Diagnostic Solutions 

Order Information and Product Support

For clinical diagnostic labs and healthcare providers only.

fortitude@mirxes.com

Media Coverage of MiRXES COVID-19 Solutions