COVID-19 IgM and IgG antibody Test
Over 6 million tests currently available
When Speed and Precision are Essential
Our lateral flow immunoassays test provides a much easier and faster way to determine previous exposure to the virus that causes COVID-19. Unlike other antibody tests, our test does not require extensive laboratory operations and can be performed on site, under the supervision of a health care professional, consistent with the terms of our FDA Authorization for these tests (download FDA EUA letter of authorization here) .
Orders under 100,000 shipped next day from either our Pennsylvania or Nevada facilities.
Reinvigorating Society, One Test at a Time
For point-of-care assays, the BioHit SARS-CoV-2 LFA IgM/IgG Antibody assay is FDA authorized, cost effective, reliable, simple to use and results are displayed within 15 minutes. This assay has definite positive roles in confirming testing results (e.g. combined testing with RT-qPCR) particularly after eight days post onset of disease symptoms, to assess previous presence of SARS-CoV-2 virus in patients with a possible asymptomatic or questionable history, and to play a role in the screening selection of putative convalescent plasma donors.
The BioHit SARS-CoV-2 LFA IgM/IgG Antibody assay is less expensive than RT-qPCR or Antigen testing and unlike Antigen and RT-qPCR assays, its effective detection spans from five days after symptom onset to several months after disease recovery.
How The COVID-19 Antibody Test Works
The One-Step SARS-CoV2 (COVID-19) IgG and IgM Antibody Test is a lateral flow immunochromatographic assay. This means that the test is easy to administer and does not require a lab, and can provide a positive, negative, or invalid result in a matter of minutes.
The test works by washing a sample of blood or serum (liquid part of blood) over a nitrocellulose strip that the antibodies can bind to. If the IgM and/or IgG antibodies are present, a burgundy-colored band(s) will appear. A colored line appearing in the control region (C) is an internal procedural control and confirms sufficient specimen volume as well as correct procedural technique. Absence of a colored band in the test region indicates a negative test result, while a complete absence of bands in the control line indicates that the test is invalid. For more detailed information, visit our FAQs.
Interpretation of Results:
A test is positive when the control line and at least one test line appear on the test screen. The appearance of T1 test line indicates the presence of COVID-19 specific IgM antibodies, while the appearance of T2 test line indicates the presence of COVID-19 specific IgG antibodies. If both T1 and T2 lines appear, it indicates the presence of both COVID-19 specific IgG and IgM antibodies. The lower the antibody concentration is, the weaker the result line is*.
*The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
A test is negative if one colored line appears in the control region, while no apparent colored line(s) appear in the test line region.
A test is considered invalid when the control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. If this happens, review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
We have been using Avrio Genetics BioHit COVID-19 antibody test for a few months. We have found it to be accurate, sensitive and specific. This test can be used to assess IgM and IgG status on suspected patients. It can be used to assess recent exposure and allows rapid screening in a cost-effective manner. This is not a replacement or in lieu of the PCR test. PCR testing has its place in the testing suspected COVID-19 patients. With this antibody test we have been able to screen large populations and we are very happy with the test.