Megna Rapid Antibody Test
Megna Health’s Rapid COVID-19 IgM/IgG Antibody 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 Rapid Antibody Test
Results are for the detection of COVID-19 antibodies IgM and IgG. The IgM antibody to COVID-19 is generally detectable in blood couple of days after initial infection, and IgG antibody is detectable typically after 7 days and stay in immune system longer. Although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
COVID-19
Megna Rapid COVID-19 Antibody Test
A Rapid Point of Care Test
- Sensitivity and Specificity
− COVID-19 – Sensitivity 100%, Specificity 95% - FDA Emergency Use Authorization (EUA)
- Visually read in 15 minutes
- For use in CLIA waived Point of Care facilities operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
COVID Clinical Evaluation
COVID-19 Sensitivity
100%
Specificity
95%
