Megna Health’S Diagnostic Products
Megna Health Rapid COVID-19 IgG and IgM Combo Test Kit
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 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 / NCI in 110 samples
- NIH Test Summary:
- Sensitivity: Combined 100% and IgG 100%, IgM 83%
- Specificity: Combined 95%
Easy to Use and Manufactured in US
- Sample: only one drop sample from fingerstick
- Time to show results: less than 15 minutes
- Manufactured in Pennsylvania, US
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|
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.
General Information about Antibody Tests for COVID-19
Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those that may be asymptomatic or have recovered. Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen by looking at their immune response. In contrast, the RT-PCR tests currently being used globally to diagnose cases of COVID-19 can only indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently recovered. These tests can give greater detail into the prevalence of a disease in a population by identifying individuals who have developed antibodies to the virus.
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 nasal swab, throat swab and sputum from individuals who are suspected of COVID-19 within the first seven days of the onset of symptoms.
Results will be visually shown within 30 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
Description of types of serology assays
Rapid diagnostic test (RDT): This is typically a qualitative (positive or negative) lateral flow assay that is small, portable, and can be used at point of care (POC). These tests may use blood samples from a finger prick, saliva samples, or nasal swab fluids. RDTs are often similar to pregnancy tests, in that the test shows the user colored lines to indicate positive or negative results. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM), or viral antigen. In some cases, it can be beneficial to measure baseline (before infection) of IgG and IgM titers.
Enzyme-linked immunosorbent assay (ELISA): This test can be qualitative or quantitative and is generally a lab-based test. These tests usually use whole blood, plasma, or serum samples from patients. The test relies on a plate that is coated with a viral protein of interest, such as Spike protein. Patient samples are then incubated with the protein, and if the patient has antibodies to the viral protein they bind together. The bound antibody-protein complex can then be detected with another wash of antibodies that produce a color or fluorescent-based readout. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM).
Neutralization assay: This test relies on patient antibodies to prevent viral infection of cells in a lab setting. Neutralization assays can tell researchers if a patient has antibodies that are active and effective against the virus, even if they have already cleared the infection. These tests require whole blood, serum, or plasma samples from the patient. Neutralization assays depend on cell culture, a lab-based method of culturing cells that allow SARS-CoV-2 growth (like VeroE6 cells). When virus and cells are grown with decreasing concentrations of patient antibodies, researchers can visualize and quantify how many antibodies in the patient serum are able to block virus replication. This blocking action can happen through the antibody binding to an important cell entry protein on the virus, for example.
Chemiluminescent immunoassay: This test is typically quantitative, lab-based, and uses whole blood, plasma, or serum samples from patients. A variation of this test can use magnetic, protein-coated microparticles, known as a chemiluminescent microparticle immunoassay. The test relies on mixing patient samples with a known viral protein, buffer reagents, and specific enzyme-labeled antibodies that allow a light-based, luminescent read-out. Any antibodies in the patient sample that react to the viral protein will form a complex. Then, (secondary) enzyme-labeled antibodies are added that bind to these complexes. This binding induces a chemical reaction that produces light. The amount of light (radiance) emitted from each sample is then be used to calculate the number of antibodies present in a patient sample. This test can look for multiple types of antibodies, including IgG and IgM.
|Type of test||Time to results||What it tells us||What it cannot tell us|
|Rapid diagnostic test (RDT)||10-30 minutes||The presence or absence (qualitative) of antibodies against the virus present in patient serum.||The amount of antibodies in the patient serum, or if they are able to inhibit virus growth|
|Enzyme linked immunosorbent assay (ELISA)||2-5 hours||The presence or absence (quantitative) of antibodies against the virus present in patient serum.||If the antibodies are able to inhibit virus growth.|
|Neutralization assay||3-5 days||The presence of active antibodies in patient serum that are able to inhibit virus growth ex vivo, in a cell culture system.||It may miss antibodies to viral proteins that are not involved in replication.|
|Chemiluminescent immunoassay||1-2 hours||The presence or absence (quantitative) of antibodies against the virus present in the patient serum.||If the antibodies are able to inhibit virus growth.|
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