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, dentist’s offices, 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%
- 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