Serum collection from patients with Borrelia miyamotoi disease

The purpose of this procurement is to obtain clinical specimens from well-characterized patients with Borrelia miyamotoi disease from the upper midwest (Wisconsin, Minnesota), northeast (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont) or mid-Atlantic (New Jersey, New York, Pennsylvania) states as well as supporting clinical and laboratory information to expand a standardized national repository of serum samples for the development of improved serologic tests for Lyme disease and Borrelia miyamotoi disease. This repository and database of clinical information will be maintained by the Division of Vector-Borne Diseases, CDC. This serum bank will be available for external requestors for use in developing and evaluating improved serologic tests. This effort will allow CDC to broadly support the development and validation of improved serologic assays for Lyme disease and Borrelia miyamotoi disease by providing well-characterized positive control serum samples from patients with Borrelia miyamotoi disease and anonymized clinical information to qualified investigators. Specifically, these sera will enhance the development of Lyme serologic tests with improved specificity and the development of Borrelia miyamotoi serologic tests with improved sensitivity and specificity. SCOPE OF WORK This scope of work pertains to a non-severable contract with a health care institution or medical care provider within the upper midwest (Minnesota, Wisconsin), northeast (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont) or mid-Atlantic (New Jersey, New York, Pennsylvania) states where cases of B. miyamotoi disease have been previously confirmed by PCR testing. Obtain and deliver to CDC, two serum samples of approximately 15 mL each, collected at least 30 days apart, from at least 10 individuals with well-characterized (both clinical and laboratory data) Borrelia miyamotoi disease. The vendor will secure Institutional Review Board (IRB) approval prior to collection of clinical samples for this procurement and will obtain informed consent from each donor. NOTE: Proposals due September 8, 2022 at 9:00