Serological Assays for the detection and characterization of influenza viruses

Amendment 2 is being issued to extend due date to 12/10/2024 for interested parties to respond for Phase I. This contract is for one 12-month base period, and four, 12-month option periods for the testing of immunological responses of human samples collected from vaccine effectiveness studies of seasonal and pandemic influenza vaccine, randomized controlled trials of influenza vaccines, and/or outbreak investigations using HAI assay.

The testing of human samples will be done in batches and is dependent upon completion of studies or outbreak investigations. The government will provide the schedules for the delivery of the study samples at contract award, if samples are already collected, or two months prior to the study completion. The government will provide standard operating procedures (SOPs) for assay creation to the contractor.

The government will also provide two proficiency panels per each period of performance, within the contract performance period as well as positive and negative controls to the contractor, to confirm proper assay performance by contractor technicians. Samples will be evaluated using government furnished seasonal influenza viruses and/or antigens. In addition to the core requirement above, the contract also consists of an optional task for the development and validation of a new serology assay comparable to HAI.

The government will provide positive and negative controls to the contractor as well as seasonal influenza viruses and/or antigens to validate assay and compare its sensitivity and specificity against HAI.