Megna Rapid COVID-19 Antibody IgG & IgM 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 and plasma (ACD).
Key Performance of the Rapid COVID-19 Antibody Test
Studied in 411 patients both positive and negative, data from the 411 patients are summarized in the Instruction for Use below
Also validated independently by NIH / NCI in 110 samples
NIH/NCI Test Results:
Sensitivity: Combined 100% and IgG 100%
Specificity: Combined Specificity: 95%
Easy to Use and Manufactured in US
Sample: only 2 uL sample needed
Time to show results: less than 15 minutes
Manufactured in Pennsylvania, US
Easy to Read & Interpret Results
|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.
Antibody Formation and Symptoms Onset
Megna Rapid Antibody Test INTENDED USE
The 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 SARS-CoV-2 in human serum and acid citrate dextrose (ACD) plasma. The Rapid COVID-19 IgM/IgG Combo Test Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Rapid COVID-19 IgM/IgG Combo Test Kit should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, 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.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
The sensitivity of the Rapid COVID-19 IgM/IgG Combo Test Kit after early infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for Rapid COVID-19 IgM/IgG Combo Test Kit may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.
The Rapid COVID-19 IgM/IgG Combo Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Rapid Antibody Test PRINCIPLE
Rapid COVID-19 IgM/IgG Combo Test Kit utilizes the principle of immuno-chromatography. Mouse anti- human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgM line in the test window is closer to the sample well followed by IgG line. As the test sample flows through the membrane
within the test device, the colored COVID-19 virus recombinant antigen-colloidal gold conjugate forms complexes with specific antibodies (IgM and/or IgG) to COVID-19 virus, if present in the sample. The antigen targets a segment of the SARS-CoV-2 nucleocapsid (N) protein. This complex moves further on the membrane to the test region where it is captured by the anti-human IgM and/or human IgG antibodies coated on the membrane leading to formation of a colored band, which indicates positive test results. Absence of this colored band in the test window indicates a negative test result. A built-in control line will always appear in the test window when the test is performed properly, regardless of the presence or absence of anti-2019 novel coronavirus antibodies in the specimen.
Rapid Antibody Test WARNINGS AND PRECAUTIONS
For use under an Emergency Use Authorization Only. For in vitro diagnostic use only.
This test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Do not use the product beyond the expiration date.
Do not use the product if the pouch is damaged or the seal is broken.
Handle all specimens as potentially infectious.
Follow standard Lab procedure and biosafety guidelines for handling and disposal of potentially infectious material. When the assay procedure is completed, dispose specimens after autoclaving at 121º C for at least 20 min or treating with 0.5% Sodium Hypochlorite for 1-2 hours.
Tests are for single use only.
Rapid Antibody Test CONDITIONS OF AUTHORIZATION FOR LABORATORIES
The Rapid COVID-19 IgM/IgG Combo Test Kit Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas
Authorized laboratories using the Rapid COVID-19 IgM/IgG Combo Test Kit (“your product” in the conditions below), must adhere to the Conditions of Authorization indicated in the Letter of Authorization as listed below:
Authorized laboratories* using your product will include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
Authorized laboratories using your product will use your product as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run your product prior to initiating testing.
Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
Authorized laboratories will collect information on the performance of your product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Megna Health Inc. (email: email@example.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of your product of which they become aware.
All laboratory personnel using your product must be appropriately trained in immunochromatographic techniques and use appropriate laboratory and personal protective equipment when handling this kit and use this product in accordance with the authorized labeling. All laboratory personnel using the assay must also be trained in and be familiar with the interpretation of results of the product.
Megna Health Inc., authorized distributors, and authorized laboratories using your product will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.
*The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests” as “authorized laboratories.”
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.
The Johns Hopkins Center for Health recently released a report detailing considerations for a national strategy on serology testing, including actions for leaders and areas for continued research. You can find this report here.
Frequent Asked Questions
Q: Why should I try the rapid antibody test?
A: Rapid antibody assay can provide you information about one’s recent and previous infection. Combo antibody test kits like Megna Health’s kit test both IgM and IgG simultaneously. IgM forms 2 -3 days after infection and lasts about 1 week, while IgG forms about a week after infection and lasts longer. IgG is indication of immunity to some extent. Although antibody tests are not considered as diagnostic purpose for COVID-19, it provides alternative option given long waiting time and inconvenient sampling process for PCR tests.
Q: Is the rapid antibody test safe?
A: Yes. It operates with serum and plasma (ACD) samples. However, Megna Health is seeking authorization to use the kit with finger pricking blood so that “at home” use may be possible later.
Q. What’s difference between PCR and antibody test?
A: PCR test presence of the virus, which mainly happens in beginning of infection, while antibody test for presence of IgM (2 -3 days after infection ) and IgG (one week after infection). But the main advantage of rapid antibody tests are easy sampling and quick results (less than 15 minutes), and no need for expensive PCR equipment.
Q: Is the Megna Health’s Rapid Antibody Test authorized by FDA?
A: Yes, it was authorized by FDA EUA (Emergency Use Authorization) on July 17. Attached is the FDA approval cover letter
Q: Is the product manufactured in US?
A: Yes. Our test kits are manufactured in Pennsylvania.
Q: What’s the Megna Health’s Rapid Antibody Test’s accuracy?
A; Based on independent study of 110 subjects by NIH / NCI (National Cancer Research), our test kits demonstrated 100% sensitivity for IgG, and for combined IgG/IgM, specificity has been shown to be 95%.
Q: How long does the rapid test take to see the results?
A: 15 minutes
Q: How much sample does the assay take?
A: Just one drop (2 – 5 uL )
Q: What’s the difference between IgM, IgG stand alone vs. the combo test?
A: There are products just for IgG or IgM, but combo test kits test both IgG and IgM from the same test. As discussed earlier, IgM antibodies indicate current infection, it would be compliment to PCR and antigen assays. However, since IgM antibodies last only limited time before IgG formation, it’s technically more challenging to test IgM with acceptable sensitivity comparing to just detecting just IgG antibodies. Therefore, combo test provides more timely information about recent or past infections.
Q: Who can perform the test?
A: All the antibody test kits approved by FDA EUA today including ours are supposed to be performed in certified labs.
Q: What’s next product goal for Megna Health’s development?
A: Megna Health is preparing for submission for expanded scope for Point of Care (POC) and home use for its Rapid COVID-19 Test Kit.
Q: What info can the antibody test help with vaccine process?
A; Information from IgG and combo antibody tests indicate one’s immunity to COVID-19 virus to certain extent. Presence of IgG may help one to decide if they need two vaccine injections or just one.
Q: Is the antibody test covered by my insurance?
A: Yes. HCPT codes are well established for reimbursement with prescription from a doctor.
People with COVID-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe illness…
Antibody Serology testing for COVID-19 is at increased demand in order to better understand presence of antibodies…
Rapid Antigen test detects presence of virus antigen in less than 30 minutes, currently under FDA EUA review…
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.
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