The World Health Organization (WHO) is exploring the interest of companies to participate in a large comparative evaluation of commercially available antibody detecting tests for SARS-CoV-2 at the National Serology Reference Laboratory, a division of St. Vincent Institute of Medical Research, Australia, and in cooperation of other partner including FIND, Erasmus Medical Centre, Duke NUS Singapore and the International Vaccines Institute.
The WHO SARS-CoV-2 antibody detecting assay performance evaluation will commence in December, 2020 under the coordination of WHO/WHE (World Health Emergencies programme). Tests of different formats e.g. ELISA, RDT, that are commercially available to detect antibodies against SARS-CoV-2 will be eligible. Participation in the evaluation scheme requires acceptance to enter the WHO Emergency Use Listing process (pre-submission call and letter of application).
How to complete the Expression of Interest (EOI):
The EOI should be completed using the online web-form found here: https://extranet.who.int/dataformv3/index.php/182642?lang=en by 7 December, 2020. If any problems are encountered, please send an email to cunninghamj@who.int with the subject heading: SARS-CoV-2 antibody assay comparative performance evaluation: EOI.
Although the submission of an EOI will not be binding on either party, the submission is required by the deadline for inclusion of each product into the laboratory evaluation. Depending on the number of products submitted for inclusion, manufacturers may be restricted to a smaller number of products compared to those submitted in the Expression of Interest. Furthermore, priority will be given to products that do not need a proprietary platform, are associated with good performance in published reports that meet quality criteria and align closely with characteristics of WHO target product profiles for priority COVID-19 diagnostic tests.
Fees for participation:
No fees will be charged for the evaluation but participants will be required to donate test kits in the required volumes (refer to protocol).