Test both COVID-19 IgM & IgG in 15 mins.
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.
It’s authorized for use in CLIA waived Point of Care facilities operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Studied in 411 patients both positive and negative, data from the 541 patients including 130 patients with fingerstick samples are summarized in the Instruction for Use below
Also validated independently by NIH / NCI (National Caner Institute) in 110 samples
NIH/NCI Test Results:
Sensitivity: Combined 100% and IgG 100%
Specificity: Combined Specificity: 95%
Only one drop of sample from fingerstick needed
Time to show results: less than 15 minutes
|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.
The 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 SARS-CoV-2 in human serum, acid citrate dextrose (ACD) plasma and fingerstick whole blood. 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 of fingerstick whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
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.
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 10 minutes without utilizing additional equipment.
A mobile App is available to display the result.
Tested in patients within 7 days Symptoms Onset. Sensitivity 97% Specificity 100
The test is manufactured by Megna Health
The test has been CE Certified for European market
Not available for US market at this time
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…
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 symptoms onset and lasts about 1 week, while IgG forms about a week after symptoms onset and lasts longer. IgG is indication of immunity to some extent. Antibody tests are not considered as diagnostic purpose for COVID-19, it provides additional information which other type of tests don’t.
A: Yes. It operates with fingerstick whole blood samples, serum and plasma (ACD) samples. Megna Health is currently seeking authorization for prescription home use with with fingerstick samples.
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.
A: Yes, it was authorized by FDA EUA (Emergency Use Authorization) in July 2020 and extended to CLIA waived Point of Care facilities with fingerstick samples on April 22, 2021. Attached is the FDA approval cover letter
A: Yes. Our test kits are manufactured in Pennsylvania.
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%.
A: 15 minutes
A: Just one drop from fingerstick sampling.
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.
A: Megna Health Rapid COVID-19 Test can be performed with fingerstick samples at any CLIA waived Point of Care facilities such as clinics, dentist’s offices and pharmacies, etc and any CLIA certified laboratories,
A: Megna Health has submitted application for extension to prescription home use for its Rapid COVID-19 Test Kit.
A: Be aware that SARS-CoV-2 antibody tests help health care providers identify whether someone has antibodies to SARS-CoV-2, the virus that causes COVID-19, indicating a prior infection with the virus. However, more research is needed to understand the meaning of a positive or negative antibody test, beyond the presence or absence of antibodies, including in people who received a COVID-19 vaccination, in people who have been exposed and have SARS-CoV-2 antibodies, and in people who are not fully vaccinated.
If you have not been vaccinated: Be aware that a positive result from an antibody test does not mean you have a specific amount of immunity or protection from SARS-CoV-2 infection. If you have a positive test result on a SARS-CoV-2 antibody test, it means that it is possible you were previously infected with the SARS-CoV-2 virus. Talk with your health care provider about the meaning of your SARS-CoV-2 antibody test results.
If you received a COVID-19 vaccination: Continue to follow the CDC’s recommendations for fully vaccinated people. Be aware that if you have a positive test result on a SARS-CoV-2 antibody test, it is possible you were previously infected with SARS-CoV-2. A COVID-19 vaccination may also cause a positive antibody test result for some but not all antibody tests. You should not interpret the results of your SARS-CoV-2 antibody test as an indication of a specific level of immunity or protection from SARS-CoV-2 infection. Talk to your health care provider or your state and local health departments if you have questions about whether an antibody test is right for you.
A: Yes. HCPT codes are well established for reimbursement with prescription from a doctor.
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.
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 CLIA waived Point of Care facilities and 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.
The Rapid COVID-19 IgM/IgG Antibody 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 Megna Health Rapid COVID-19 IgM/IgG Antibody Combo Test Kit in the conditions above), must adhere to the Conditions of Authorization indicated in the Letter of Authorization as listed above.
Authorized laboratories using Megna Health Rapid COVID-19 IgM/IgG Antibody Test will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
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.
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 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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