Megna Health Rapid COVID-19 IgG & IgM Combo Test Kit

FDA EUA Authorized with Fingerstick Samples and CLIA Waived

Megna Health’s Rapid COVID-19 IgM/IgG Combo Test Kit is a lateral flow immunoassay intended for qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to COVID-19 simultaneously in serum, plasma (ACD) and fingerstick whole blood.

Megna Health Rapid COVID-19 IgM/IgG Combo Test has been authorized for use with fingerstick samples at CLIA waived Point of Care facilities such as clinics, or dentist’s office, and pharmacies, etc.

Key Performance Results from Clinical Studies
  • Studied in 411 patients both positive and negative
  • Data from the 411 patients are summarized in the Instruction for Use (IFU) below
  • Also validated independently by NIH / National Cancer Institute in 110 samples
  • NIH Test Summary:
    • Sensitivity: Combined IgM & IgG 100%
    • Sensitivity: IgG 100%

Lancets by Lifescan and Manufactured in US

Click here for Instruction For Use

Click here for Quick Reference Instruction For Use with Fingerstick

Click here for Information for Health Professionals

  • Sample: only one drop sample from fingerstick
  • Time to show results: less than 15 minutes
  • Manufactured in Pennsylvania, US
  • Come with auto lancets by Lifescan

Click here for Information for Patients

Easy to Read & Interpret Result
IgM + / IgG –Recent infection with COVID-19
Both IgM + / IgG +Recent infection with COVID-19
IgM – / IgG +Previous infection with COVID-19
Both IgM – / IgG –No infection or not enough detectable antibodies in early infection

Megna Rapid COVID-19 IgM/IgG Combo Test Kits are manufactured in facilities in Pennsylvania.

Rapid COVID-19 Antigen Test

The Rapid COVID-19 Antigen Test is a lateral flow immunoassay intended for rapid qualitative detection of nucleocapsid antigens from COVID-19 in human nasopharyngeal and anterior nasal swabs, sputum specimens from individuals who are suspected of COVID-19 within the first five days of the onset of symptoms.

Results will be visually shown within 10 minutes without utilizing additional equipment. A mobile App is available to display the result.

The test kit is manufactured in Pennsylvania and has been CE Certified for European market.

Not available for US market at this time

Rapid COVID-19 & Flu A/B Test

The Rapid COVID-19 & Flu A/B Antigen Test is a lateral flow immunoassay intended for rapid qualitative detection of antigens from COVID-19 and Flu A/B in human nasal swabs from individuals who are suspected of COVID-19 or Flu within the first five days of the onset of symptoms.
Results will be visually shown within 20 minutes without utilizing additional equipment. A mobile App is available to display the result.

The test kit is manufactured in Pennsylvania.
Not available for US market at this time

COVID-19 Antibody Treatment

Coming

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