The MEXACARE COVID-19 IgG/IgM Antibody Test is a rapid, qualitative, in vitro immunochromatographic test for the differential detection of IgM & IgG antibodies to SARS-CoV-2 virus in human serum, plasma or whole blood samples. The test is used to determine current or past infection with SARS-CoV-2 virus and to track disease status following SARS-CoV-2 virus infection. To evaluate the performance of the MEXACARE COVID-19 IgG/IgM rapid test, multiple clinical studies were conducted in Germany, USA, Canada, China and other European countries with a total of 2,000+ patient samples tested.
Due to direct access to positive plasma samples at the Heidelberg site, we were able to perform validated studies to exclude cross-reactions with other coronavirus strains. Due to our unique access to laboratory equipment from the leading European, American and Asian manufacturers, we were able to compare our rapid test with quantitative laboratory results. This is extremely important to understand how a rapid test behaves directly at the sensitivity limit, specifically to distinguish a positive result from a negative result there. According to our current assessment, no other diagnostic company currently has such a broad data base on a COVID-19 antibody test!
The fight against the SARS-CoV-2 virus and its consequences places high demands on all parties involved. As a certified manufacturer of high-quality diagnostic products, we see our mission in constantly adapting our products to the latest technology and the highest quality standards in order to offer the best possible product to authorities, physicians and laboratories. For this reason, a total of 2,000+ patient samples were tested in multiple clinical studies in the U.S., Canada, China and Germany to evaluate the performance of the MEXACARE COVID-19 IgG / IgM rapid test. As a partner company of a raw material manufacturer for the diagnostics industry, we were able to access first-hand patient material, among others.