Through a new partnership with Diazyme Laboratories, Inc., the Biomedical Advanced Research and Development Authority (BARDA) announced this week that efforts are underway to develop a fast, high-throughput, fully automated test to detect SARS-CoV-2 neutralizing antibodies.
The focus is on individuals with an adaptive immune response to COVID-19, otherwise known as those previously infected. Though the COVID-19 pandemic has stretched on since 2019, the level and duration of acquired immunity in individuals previously infected with SARS-CoV-2 remain unknown.
Diazyme seeks to change that. Awarded a BARDA contract for its SARS-CoV-2 Neutralizing Antibody CLIA Kit, the company aims to design a moderate complexity assay that does not handle live viruses. Built on the technology involved in the SARS-CoV-2 Spike protein Receptor Binding Domain (RBD) and the human Angiotensin-Converting Enzyme 2 (hACE2) to detect the absence or presence of SARS-CoV-2 neutralizing antibodies in human plasma or serum, the test is also expected to be moddable for us against current or future SARS-CoV-2 variants.
Ultimately, the developers hope to make a test with a results turnaround of as little as 35 minutes. These tests will run on Diazyme’s already-authorized automated analyzer, meaning as many as 3,600 tests will be able to be run each day.
First, Diazyme intends to submit an application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CLIA Kit. At that point, it could be potentially utilized throughout the nation. The company said this would allow it to evaluate patients’ abilities to fight current and future viral infections, assess the real-world effectiveness of vaccines in greater detail, and monitor herd immunity. Following additional development and clinical studies, the company also intends to apply for a 510(k) clearance.