Making SARS-CoV-2 testing available to labs everywhere
As COVID-19 multiplied across the globe in early 2020, IVD companies raced to provide testing solutions. However, rapid development of diagnostic solutions led in some cases to compromised reagent quality, causing confusion and concern amongst clinicians and lab professionals.
With this background, Erba Mannheim committed to develop reliable and affordable solutions to SARS-CoV-2 testing. First out have been the ErbaLisa IgG and IgM antibody ELISA kits. These were developed and manufactured by Calbiotech, Erba group’s immunoassay center of excellence in California.
Quality and performance were top priorities. The IgG kits use Spike protein antigens to ensure clinical relevance and specificity, and IgM kits use a combination of Spike and Nucleocapsid antigens. Performance and accuracy were extensively validated by multiple studies in universities and public/private laboratories. With CE mark and pending US EUA authorization, ErbaLisa COVID-19 assays gained approval by strict global regulatory bodies including Brazil’s ANVISA and ICMR in India.
Our commitment is to make quality diagnostic solutions affordable to growing labs across all emerging markets in Asia, LATAM, MEA, Eastern Europe and Russia. We believe these products answer the immediate needs and are proud to be helping in the fight against COVID-19.