Study to harmonize serological assay data Is underway

The National Cancer Institute–Frederick National Laboratory Clinical and Translational Serology Operations Team is coordinating the Collaborative Assay Harmonization Study. The effort seeks to improve scientists’ ability to compare data between SARS-CoV-2 studies and vaccines.

Participating investigators are comparing the performance of approximately 30 SARS-CoV-2 serology assays by using a common set of samples from vaccinated people and people with a history of SARS-CoV-2 infection. Each assay has previously been optimized and validated at laboratories involved in clinical studies assessing individuals’ serological levels of SARS-CoV-2 antibodies after infection and vaccination.
Nineteen institutions have confirmed their participation. A kickoff meeting was held virtually on August 18, and the samples were shipped to the laboratories during the week of August 23.

The many SARS-CoV-2 serology assays available to the field use different reagents and procedures. The lack of standardization represents a hindrance to a coordinated pandemic response. These assays’ results can’t be currently compared or cross-referenced, restricting their potential usefulness.

Data from the Comparative Assay Harmonization Study represent movement toward a solution to that problem. The investigation is ongoing. Results will be presented once the study is completed and data are analyzed.

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