In November 2021, under the auspices of WHO’s COVID-19 Technology Access Pool (C-TAP), the Medicines Patent Pool signed a worldwide licence with the Spanish National Research Council (CSIC) for a COVID-19 serological antibody diagnostic test. The diagnostic test effectively checks for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine.

Technology offered: ELISA antibody technology

Technology holder: Spanish National Research Council (CSIC)

License: Worldwide, non-exclusive and transparent license available here.

C-TAP categorisation after WHO technical pre-assessment: Category III

Description of the technology: The COVID-19 serological antibody technology effectively checks for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine.  This represents the first transparent, global, non-exclusive licence for a COVID-19 health tool, and the first test licence signed by MPP and included in the WHO COVID-19 Technology Access Pool.

The aim of the licence is to facilitate the rapid manufacture and commercialization of CSIC’s COVID-19 serological test worldwide. The agreement covers all related patents and the biological material necessary for manufacture of the test. CSIC will provide all know-how to MPP and/or to prospective licensees as well as training. The licence will be royalty-free for low- and middle-income countries and will remain valid until the date the last patent expires.

The tests are simple to use and suitable for all settings with a basic laboratory infrastructure, such as those found in rural areas in low- and middle-income countries. The reading can theoretically be done manually (with naked eye comparing the colour of the wells against the colour chart), but an ELISA reader is recommended for greater accuracy of results.

Promising performance data in the European population will need to be supplemented by the companies that will produce this technology if they plan to sell the test in low- and middle-income countries.

C-TAP invites interested manufacturers based anywhere in the world to express their interest in obtaining a sublicence by submitting a single email to CTAPDiagnostics@medicinespatentpool.org.org with complete, detailed responses to the questionnaire provided here.