High Throughput SARS-CoV-2 Binding Antibody Immunoassay for Testing of Clinical Samples and Variant Assessment   2

"High Throughput SARS-CoV-2 Binding Antibody Immunoassay for Testing of Clinical Samples and Variant Assessment"

The USG has a need for laboratory assay capacity sites for analysis of serum samples collected from subjects enrolled in COVID-19 vaccine clinical trials to provide serologic data to support the establishment of a correlate of protection to help facilitate expanded use of approved COVID-19 vaccines and accelerated approvals of additional vaccines. Serum samples are tested to ascertain the ability of the vaccine to induce an immune response. The SARS-CoV-2 spike protein (S), which mediates binding to host cells, is highly immunogenic with the receptor-binding domain (RBD) being the target of many neutralizing antibodies. Serological analyses of COVID-19 vaccine trial specimens must be performed using the high throughput multiplex MSD-ECL immunoassay because it allows for simultaneous measurement of multiple SARS-CoV-2 proteins in the same well.

The objectives of this contract are: (1) test the clinical trial samples of COVID-19 vaccines using the validated MSD-ECL immunoassay for COVID-19 in compliance with Good Clinical Laboratory Practice (GCLP); (2) develop and validate assays for SARS-CoV-2 emerging variants by the Contractor; and (3) test serum samples from human subjects enrolled in clinical trials of COVID-19 vaccines using the variant assay in compliance with GCLP.