NEW YORK – The Foundation for Innovative New Diagnostics (FIND) on Wednesday issued an expression of interest (EOI) to developers of tests for the novel coronanvirus, SARS-CoV-2, who are interested in getting their assays evaluated using a standardized, independent protocol.
FIND is collaborating with the World Health Organization to perform a standardized evaluation of currently available molecular diagnostic tests to assess test performance and "thereby better inform public health policy, surveillance programs, and clinical management of patients" suspected of having SARS-CoV-2, particularly in resource-constrained settings, FIND said in a statement.
The results from the EOI will be used to include assays in analytical and clinical evaluation studies to be performed by an independent, third-party reference lab. Study results will be shared with the global health community to inform diagnostic testing approaches. All tests submitted to the EOI will be included in the SARS-CoV-2 diagnostics pipeline tracker on FIND's website, it said.
Requirements for test developers for the EOI include compliance with good laboratory practice, RUO certification of kits, with finalized instructions for use, and immediate availability of the kits for procurement.
The EOI opened on Feb. 20 and will close on Feb. 26. Kit procurement will be completed on March 13.
Since the end of December, when the coronavirus was first reported in China, several diagnostic manufacturers have been rushing to develop tests to detect the pathogen.