When Speed and Precision are Essential
BioHit COVID-19 IgM and IgG antibody Rapid Test
Our lateral flow immuno-assays rapid 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 at Point of Care, under the supervision of a health care professional with access to a high-complexity CLIA-compliant laboratory.
Our organization strictly adheres to FDA policies and regulations covering the sale of diagnostic testing supplies for COVID-19. While personal protective equipment (PPE) may be purchased without restriction, consistent with current FDA CLIA guidance, we restrict sales of diagnostic tests to medical professionals qualified to use these “Point of Care” kits.
FDA Policy for Diagnostic Tests for Coronavirus Disease-2019
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Reinvigorating Society, One Test at a Time
In addition, RDTs help to prevent the spread of COVID-19 through early detection and highly sensitive and specific testing. Because of this, RDTs are ultimately able to decrease the uncertainty surrounding the lack of reliable testing, as well as the likelihood of a “false positive”.
Unlike other forms of testing, our Rapid Antibody Testing Kits are much more affordable and cost-effective, and only take 15 minutes or less to provide a result. View eligibility requirements.
How The COVID-19 Antibody Rapid Test Works
The One-Step SARS-CoV2 (COVID-19) IgG and IgM Antibody Rapid 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:
POSITIVE: 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 SARSCoV-2 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: 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.
INVALID: 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.
QUALITY CONTROL: A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
Accurate, Reliable COVID-19 Testing at Scale is Within Reach
Flexible order volumes and shipping terms available.
