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
Other IVD Products
Rapid AFP Test Card
Rapid AFP Test is an lateral flow based one-step in vitro test. It is designed for the rapid qualitative determination of AFP in serum, plasma or whole blood. It helps to aid in the diagnosis of liver cancer or cancer of ovaries or testicles.
Not available in US at this time.
Rapid Fecal Occult Test Card
Rapid Fecal Occult Blood (FOB) test is a qualitative test that detects human hemoglobin in human fecal specimens. The test is a visual, one step in-vitro assay. Detection of FOB helps to diagnose gastrointestinal bleeding.
Not available in US at this time.
Rapid PSA Test Card
Semi-quantitative determination of human prostate specific antigen (PSA) in serum, plasma or whole blood. PSA is a protein produced by both cancerous and non-cancerous tissue in the prostate in man.
Not available in US at this time.
Rapid Pregnancy Urine Self-Test Card
HCG (human chorionic gonadotropin) Pregnancy Urine Self-Test Kit is a single use device, for qualitative detection of HCG in urine specimen. The Test Kit provides fast and convenient HCG testing with reliable result when you needed to know.
Not available in US at this time.
