The Influenza Division at the Centers for Disease Control and Prevention (CDC) is conducting market research for contract services focused on the development of serological and diagnostic assays including a Field Influenza Immunity Test and a High-Throughput Influenza Laboratory Immunity Test.
The contract is also focused on the improvement of current serological assays used at CDC including the development of a Synthetic hemagglutination inhibition (HI) assay as well as the development of a HI automation system.
Lastly, this contract will also focus on the development of an enzyme-linked immunoassay to assess influenza vaccine potency and efficacy.
The test most often used to evaluate immunity and antigenicity related to influenza is the hemagglutination inhibition (HI) assay. This assay has been used for over 60 years because it is easy to perform. Data obtained from the assay is essential for World Health Organization (WHO) and Food and Drug Administration (FDA) to make influenza vaccine recommendations. However, this assay is difficult to make mobile, standardize, and automate because it relies on the use of red blood cells, antisera dilutions and humans to read the test results.
The purpose of this activity in the contract is to develop new technologies to improve upon the traditional HI assay to make the assay mobile, high-throughput, standardized, and automated.
The Influenza Division is also responsible for influenza outbreak investigations, seasonal vaccine strain selections, and vaccine effectiveness studies. There are often situations where the influenza laboratories are not capable of completing research projects due to a significant outbreak or emergence of a new virus subtype thus requiring a shift of testing priorities.
In these cases, HI assays, microneutralization (MN) assays, Sanger gene sequencing, and Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing for vaccine strain selection and effectiveness studies need to be outsourced to publish study results in a timely manner.
Activities supporting vaccine effectiveness and vaccine development, such as avidity antibody assays, Antibody-dependent cell-mediated cytotoxicity (ADCC) and related assays, and B-cell sequencing activities are necessary to support the vaccine development and efficacy determination activities of the entire influenza surveillance process. These activities in the contract will also serve as a vehicle for influenza surge testing when CDC laboratories are overwhelmed with other testing demands.
Given the continuous emergence of novel influenza strains, it remains important for pandemic risk assessment purposes to characterize more precisely the frequency of serum cross-reactive antibody to these novel viruses in all age groups in the United States, and to identify past exposure to human influenza viruses that may contribute to differences in the levels of antibodies detected.
This information could further be used to assess and better understand the potential for these novel viruses to spread among humans in the United States. It will also serve as a benchmark for incidences of infection in the United States population in the event these novel viruses become more widespread among humans.
The purpose of this activity in the contract is to acquire left over sera from various diagnostic laboratories across the United States to establish seroprevalences against emerging novel influenza viruses.
Lastly, as part of the USG pandemic preparedness and response, it is important to evaluate/assess influenza vaccine potency and efficacy with the goals of supporting the development, approval, and production of influenza vaccines. The purpose of this activity in the contract is the development of an enzyme-linked immunoassay to assess influenza vaccine potency and efficacy.
Further details are available via Solicitation Number: HHS-CDC-SS-2015-80791. The response deadline is April 1, 2015.
