Serological Assays for the detection and characterization of influenza viruses
Closed Pre-Solicitation Posted
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- Solicitation number
- 75D30125R73211
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
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 small business contractor to perform serological assays for detecting and characterizing influenza viruses. The contract involves testing immunological responses of human samples from vaccine effectiveness studies, randomized controlled trials, and outbreak investigations using hemagglutination inhibition (HAI) assay techniques. The base contract period is 12 months with four additional 12-month option periods, and the government will provide standard operating procedures, proficiency panels, positive and negative controls, and seasonal influenza viruses for testing. The solicitation includes an optional task for developing and validating a new serology assay comparable to HAI. Key dates include a question deadline of November 26, 2024, and a response deadline of December 3, 2024, with the full proposal due by December 10, 2024.
The contract is designated as a total small business set-aside under the NAICS category 325413 for In-Vitro Diagnostic Substance Manufacturing, with a Product Service Code of Q301 for Reference Laboratory Testing. The core requirement involves processing approximately 6,000 samples per year, with the government providing sample delivery schedules and materials for testing. The contract will utilize firm-fixed-price contract line items (CLINs) for sample testing and cost-plus-fixed-fee CLINs for optional assay development. Contractor performance will be evaluated through the Contractor Performance Assessment Reporting System (CPARS), ensuring quality and compliance with contract specifications. While specific award values are not disclosed, the comprehensive nature of the testing requirements and potential optional tasks suggest a significant investment in advancing influenza virus research and vaccine effectiveness monitoring.
Notice text
3 versions
Update #3 · Latest ·
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.
Update #2 ·
Amendment 1 is being issued to extend Q&A due date to 11/26/2024 and to extend the due date for interested parties to respond to 12/3/2024.
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.
Update #1 ·
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.
Files
| File | Type | Posted |
|---|---|---|
| A19_Solicitation_Amendment 1.docx | DOCX document | |
| Amendment_00001_RFP_75D30125R73211.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Phase I - Serological Assays for the detection and characterization of influenza viruses | Pre-Solicitation | |
| Phase I - Serological Assays for the detection and characterization of influenza viruses | Solicitation | |
| This notice | Pre-Solicitation |
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