Antibody Product Performance
The Ecotest IgG/IgM Rapid Test Device is the first FDA Authorized Point-of-Care antibody test for COVID-19. This device is scientifically known as a rapid lateral flow chromatographic immunoassay for the simultaneous qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. It is intended to be used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The results from the Ecotest are for the detection of SARS-CoV-2 antibodies. These antibodies are classified as IgG and IgM, and they are generally detectable in blood several days after the initial infection. At this point, it is unknown how long antibodies persist following infection and if the presence of antibodies confer immunity.
How It Works
The Ecotest uses anti-human IgM antibody (test line IgM), and anti-human IgG antibody (test line IgG) as well as goat anti-mouse IgG (control line C) immobilized on the nitrocellulose strip. The conjugate pad on the test strip contains recombinant SARS-CoV-2 antigen (N-Protein and Spike Protein) conjugated with colloid gold to accentuate the color development. During testing, the specimen binds with the SARS-CoV-2 antigen colloid gold particles in the test cassette. After the buffer fluid is added into the sample well, if the IgM or IgG antibodies are present, they will bind and become complex which will result in a red line to form which will confirm a reactive test result. The red line will always appear in the "Control" line region to indicate that the correct amount of specimen has been added into the sample well.
The Ecotest was evaluated in three separate clinical studies and contained multiple sites of evaluation. The test reported a 95% Confidence Interval for both IgG and IgM antibodies. The full Clinical Performance Report can be found in the "Documents" section in our product description. The following performance results are from the National Institute of Health study.
False positive results for the Ecotest may occur due to cross-reactivity from pre-existing antibodies or other possible causes. As with all diagnostic tests, all results should be interpreted together with other clinical information available to the physician. To see the full list of cross-reactants and interfering substances view the Product Insert in the "Documents" section of our product description.
The Ecotest Rapid Test Device should not be used to diagnose acute SARS-CoV-2 infection. Use of this test 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 to highly complex testing. This test is also authorized for use with fingerstick whole blood specimens only at the Point-of-Care (POC), i.e. patient care facilities operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.