Serological Assays for the Detection and Characterization of Influenza Viruses

This contract supports the CDC’s Influenza Division by performing hemagglutination inhibition (HAI) assay testing on human sera collected from vaccine effectiveness studies, clinical trials, and outbreak investigations, while also developing a new serology platform that matches or exceeds HAI’s sensitivity and specificity. The work spans a 12-month base period from May 19, 2026, to May 18, 2027, with four optional 12-month extension periods through May 18, 2031, enabling the contractor to provide surge capacity at 50% or 75% above baseline levels during public health emergencies. Key deliverables include routine HAI testing in batch format, validation of the new assay across multiple influenza subtypes and treated viruses, and compliance with strict accuracy and timeliness benchmarks of at least 97% and 99%, respectively. Performance is monitored through weekly reviews, quality assurance surveillance, and electronic submission of results adhering to Section 508 EIT accessibility standards. The contract is structured as a firm-fixed-price arrangement for routine testing and surge support, with cost-plus-fixed-fee elements for optional tasks including gap analysis and assay development. Total estimated value ranges from $1.38 million for the base period to $7.34 million if all options are exercised, with reimbursable travel capped at non-to-exceed amounts. The contractor must comply with stringent federal regulations, including HHSAR provisions limiting direct salaries to Federal Executive Schedule Level II, enforcing electronic and information technology accessibility under HIPAA, FISMA, and NIST standards, and managing government-furnished property through detailed accounting and labeling protocols. All personnel accessing sensitive data must meet HHS privacy and security requirements, including approval of Privacy Impact Assessments, and organizational conflicts of interest must be disclosed and mitigated. The Contracting Officer and Contracting Officer’s Representative, both located at the CDC in Atlanta, oversee performance, acceptance of deliverables, and payment via the Treasury’s Invoice Processing Platform, with no use of WAWF. The contractor’s UEI is KT4MLLHK99V6, and while no socioeconomic certifications are disclosed, numerous FAR clauses governing subcontracting, termination, changes, and cost allowability are fully incorporated, including alternates for changes and subcontracts that provide flexibility in contract administration.