Phase I - Serological Assays for the detection and characterization of influenza viruses
Closed Pre-Solicitation Posted
- Solicitation number
- 75D30125R
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- PSC
- Q301 Reference Laboratory Testing
- Place of performance
- Atlanta, Georgia, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Centers for Disease Control and Prevention (CDC) Office of Acquisition Services is seeking a contractor to conduct serological assays for detecting and characterizing influenza viruses. The primary contract objective involves testing immunological responses from human samples collected during vaccine effectiveness studies, randomized controlled trials, and outbreak investigations using the Hemagglutination Inhibition (HAI) assay. Samples will be delivered in batches based on study completion timelines, with the government providing standard operating procedures, proficiency panels, and necessary controls to ensure proper assay performance. The contract is structured with one 12-month base period and four additional 12-month option periods, allowing for flexible testing requirements. An optional task is also included for developing and validating a new serology assay comparable to HAI, which will be evaluated for sensitivity and specificity against existing methods.
This contract opportunity is being competed as a full and open procurement, with no specific small business set-aside, after a previous solicitation (75D30125R73211) did not receive sufficient small business participation. The contract is categorized under NAICS code 325413 for In-Vitro Diagnostic Substance Manufacturing and PSC code Q301 for Reference Laboratory Testing. The solicitation was posted on December 18, 2024, with responses due by January 8, 2025, providing potential contractors approximately three weeks to prepare their proposals. The CDC will provide seasonal influenza viruses, antigens, positive and negative controls to support the contractor's testing and validation processes. While specific award values are not disclosed in the pre-solicitation notice, the multi-year structure and comprehensive testing requirements suggest a potentially significant contract opportunity for qualified laboratories specializing in immunological testing.
Notice text
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.
This is a re-posting of 75D30125R73211; however, due to not enough small business participation, this is being competed as full and open.
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Pre-Solicitation | |
| Phase I - Serological Assays for the detection and characterization of influenza viruses | Solicitation | |
| Serological Assays for the detection and characterization of influenza viruses | Pre-Solicitation |
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| Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response | Office of the Assistant Secretary for Preparedness and Response | No set-aside |
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