FLUXERGY Reaction Mix COVID-19

January 12, 2022 0 Comments

Test Summary

The Fluxergy Analyzer system is a test platform designed for multiplex and multimodal * testing. The Fluxergy CoVID-19-Sample to-Answer-RT-PCR Test, which uses state-of-the-art PCR and microfluidic technology, has been shown to identify the SARS-CoV-2 virus in less than one hour in laboratory tests performed both by internal studies and in follow-up validation tests with patient samples from researchers at the University of California, San Diego (UCSD).

  • Real-time RT-PCR
  • Direct sample format (no nucleic acid extraction required)
  • Sample: Nasopharyngeal swab in UTM / VTM transport medium
  •  Assay objective: SARS-CoV-2 nucleocapsid gene (N gene) and polyprotein gene (orf1ab)
  • Simple workflow: Vortex swab sample in transport media, sample pipet into reaction mix, and pipette into test card

FDA Status

Validation data was submitted to the FDA as part of Fluxergy’s Emergency Use Authorization Application (USA) on March 28 of 2020. Fluxergyy products are for Research Use Only (RUO) and not for use in diagnostic procedures. Fluxergyy products are not yet approved by the FDA or USDA for in vitro diagnostic use. None of these statements has been endorsed by the FDA or USDA. Fluxergyy does not currently sell products for human or food use.

Combination PCR And SEROLOGY Test

Fluxergy is working on the rapid development of a combination PCR and Serology test. This test is designed to give two pieces of information about a patient, whether the virus is present today, as well as the immune response.

  • Samples: Nasopharyngeal swab in transport UTM / VTM media for RT-PCR. Finger tap of whole blood or plasma for LFA
  • Direct sample format (no nucleic acid extraction)
  • Sample: Nasopharyngeal swab in UTM / VTM transport medium
  • Assay target: SARS-CoV-2 nucleocapsid gene (N gene) and the polyprotein gene, orf1ab


Our syndromic panel, currently under development, is designed to be able to differentiate between the presence of SARS-CoV-2 and influenza (common flu) and other respiratory pathogens. We anticipate that our syndromic panel will be incredibly valuable during flu season.

Greater Manufacturing Capacity

On May 13, 2020, Fluxergy announced a $ 30 million investment in manufacturing our diagnostic platform. in response to the COVID-19 pandemic. We anticipate that our significant investment to intensify our manufacturing capacity will allow Fluxergy to deliver up to one million tests per month and reflects our confidence in our technology as an important and innovative solution to expand COVID-19 testing capabilities.