Repeat, Cross Sectional Serologic Survey Across USA

Project Description

LONG-TERM TESTING (11 Month Study)
MULTIPLE LABORATORIES NEEDED
USA CLIA Clinical Laboratories needed for for a repeat, cross-sectional, serologic survey using convenience samples collected from commercial laboratories across the United States. The primary purpose is a Multistate Assessment of SARS-CoV-2 Seroprevalence in Commercial Laboratory Survey (MASS-C) to estimate the proportion of people that have been infected by or vaccinated for SARS-CoV-2 during the ongoing epidemic over time, nationally and by geographic location and demographic subcategory. There will continue to be a special priority on infection and case rates among children, and therefore, proposes a sampling frame for children with specimens collected over 8-week time periods.
Study will use residual/remnant/excess, deidentified blood specimens to obtain laboratory testing toward determining U.S. seroprevalence by geographic region, pediatric age group, and time period. Offeror(s) will identify excess, remnant, or residual blood specimens from remaining volumes of previously obtained blood specimens for non-COVID-19 diagnostic or antibody testing. For all 50 states, the District of Columbia and Puerto Rico, monthly commercial lab residual sera samples will be collected, distributed by age category, and tested for both qualitative SARS-CoV-2 nucleocapsid antibodies and quantitative IgG anti-spike antibodies. More specifically, Oferror(s) will collect and test mass amounts of specimens for CLIA-approved and/or EUA-approved ELISA, COVID-19 IgG and/or IgM serological assays, as well as reflexive microneutralization testing for specimens that are seropositive by qualitative anti-nucleocapsid assay if possible. Offeror(s) will provide data reports of aggregate findings after every 8-week collection/testing period, in addition to a final report at the end of the award performance period. Offerors may propose on any or all of the required tests. This contract is anticipated to be for a base period of eleven (11) months, with one option period of twelve (12) months.