News on immunoassay systems and applications.
The latest Emergency Use Authorization is for an ELISA-based test for detecting immunoglobulin M antibodies against SARS-CoV-2 in human serum.
Developed by the Ragon Institute, the ELISA-based test measures antibodies that bind to the receptor binding domain of the SARS-CoV-2 spike protein.
Through its Access to COVID-19 Tools-Accelerator program, or ACT-A, WHO hopes to quickly identify and scale up high performing rapid antigen-based diagnostics.
The test detects IgG antibodies and has confirmed 100 percent sensitivity and nearly 100 percent specificity, according to the company.
Chembio suggested a device modification could improve performance, following an analysis of troubling NCI data. The FDA didn't agree.
