Both AFIAS and iChroma COVID-19 Point-of-Care Tests qualitatively detect IgM and IgG antibodies to the novel coronavirus SARS-CoV-2 within 10 Minutes using a whole blood, serum or plasma sample
Eatontown, NJ, April 13, 2020 - (PR.com) - Immunostics’ AFIAS COVID-19 Ab test is truly innovative because it can be performed on serum, plasma, venous whole blood or fingerstick capillary whole blood sample to qualitatively detect the presence of IgM and IgG antibodies to the novel coronavirus SARS-CoV-2 in just 10 minutes.
- AFIAS COVID-19 Ab test results can be used for identifying patients who have already developed antibodies to the novel coronavirus SARS-CoV-2, thereby allowing them to possibly return to the workforce earlier. - The Immunostics AFIAS and iCHROMA platforms are small and portable instruments that can be deployed anywhere to enable automated rapid COVID-19 Ab testing wherever needed - Immunostics point-of-care AFIAS platform does not require swabs and other related materials making testing simple and easy as well as less risky than having to obtain nasal/throat patient samples
- AFIAS COVID-19 Ab tests are available now and Immunostics is prepared to immediately deliver 20,000-40,000 tests per day - AFIAS COVID-19 platform is available in two models - (AFIAS-1-6 tests/hr) and (AFIAS-6-36tests/hr) - AFIAS comes with full connectivity (LAN, USB, RS232) and stores 5,000 patient results allowing for trending and statistical analysis - According to Dr. Gianrico Farrugia, CEO Mayo Clinic, "the serology antibody test is very important to understand who has an antibody and therefore can be presumed to have had contact with the virus and has mounted a response to it." Immunostics, Inc., a subsidiary of Boditech Med Inc., a global leader in point-of-care testing, announced today that the U.S. Food and Drug Administration (FDA) has listed their AFIAS COVID-19 Ab and iChroma COVID-19 Ab tests which are innovative, rapid, instrument-based tests intended for detection of IgG/IgM antibodies to SARS-CoV-2 in serum, plasma, venous whole blood or fingerstick capillary whole blood samples, delivering qualitative results in just 10 minutes. These tests are run on company’s AFIAS-1/AFIAS-6 and iChroma II analyzers in laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratories CLIA certificate for high-complexity testing.
"The COVID-19 pandemic is consuming significant resources and an innovative AFIAS and iChroma platform require only 30 ul fingerstick or serum/plasma blood samples, eliminating a need to use a swab and other related materials that are in short supply. The AFIAS and iChroma antibody test offers rapid results and is easy to operate by anyone enabling it to be deployed wherever COVID-19 tests are required. AFIAS’s unique features - small fingerstick sample and an easy to use point of care system - will allow us to effectively combat COVID-19," said Adam Choe, President and CEO, Immunostics, Inc. "Ease of use, simple sample application and true portability of the AFIAS and iChroma platforms will enable healthcare providers to perform COVID-19 testing at any setting such as urgent care centers, satellite labs and large healthcare centers." AFIAS and iChroma COVID-19 tests are available now to healthcare providers in the U.S. The company plans to partner with long time distribution partners to deploy tests to areas with the most urgent needs. Both platforms detect an antibody level to confirm if the body has produced an immune response to the COVID-19 disease. As we transition to going back to normalcy such as returning to work, the Ab test will enable us to identify who have overcome an infection already and identify individuals who can return to work. AFIAS-1/AFIAS-6 as well as iChroma II analyzer display the COVID-19 Ab test result qualitatively as ‘Negative’ or ‘Indeterminate’ or ‘Positive’ thereby ruling out subjective reading of colored test lines as required in case of most of the rapid test kits. "Antibody tests provide critical information for healthcare professions to aid characterizing possible prior exposure to the novel coronavirus, particularly since a significant portion of those infected are either asymptomatic or exhibit mild symptoms," said Adam Choe, President and CEO.