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
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.