Serological Assays for the Detection and Characterization of Influenza Viruses
ID: 75D30125R73235Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFCENTERS FOR DISEASE CONTROL AND PREVENTIONCDC OFFICE OF ACQUISITION SERVICESATLANTA, GA, 30333, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

MEDICAL- LABORATORY TESTING (Q301)
Timeline
  1. 1
    Posted Jan 16, 2025, 12:00 AM UTC
  2. 2
    Updated Apr 15, 2025, 12:00 AM UTC
  3. 3
    Due May 22, 2025, 6:00 PM UTC
Description

The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking proposals for a contract to provide serological assays for the detection and characterization of influenza viruses. The contract will involve performing hemagglutination inhibition (HAI) assays on approximately 6,000 human serum samples annually, with the potential for increased testing capacity during outbreaks, and aims to enhance influenza surveillance and vaccine effectiveness studies. This procurement is critical for bolstering public health response capabilities, ensuring high-throughput testing services, and fostering innovation in serological assay methods. Interested parties should note that the solicitation is currently suspended, and inquiries should be directed to Vic Veguilla at the CDC via email at jgartzke@cdc.gov for further information.

Point(s) of Contact
Files
Title
Posted
The document outlines Amendment 1 for the solicitation and contract 75D30125R73235 issued by the Centers for Disease Control and Prevention (CDC) for serological assay services for influenza virus detection. The amendment extends deadlines for proposals and updates testing schedules while maintaining all other terms unchanged. It establishes a contract structure comprising a base period and four additional option periods, focusing on sample testing and development of new serology assays, with the goal of enhancing influenza virus characterization. The contractor is responsible for conducting high-throughput testing of human samples, utilizing government-furnished materials and adhering to performance benchmarks outlined in the contract. The document emphasizes the importance of quality control throughout the assays and detailed reporting requirements while allowing for surge support in response to increased testing demands. Furthermore, it stipulates compliance with the Service Contract Act and outlines travel reimbursement guidelines. The purpose of this contract is to bolster the CDC's influenza surveillance capabilities through improved assay development and testing methodologies. Overall, it is a critical procurement effort to enhance public health response capabilities regarding influenza threats.
The document outlines Amendment 1 for the solicitation and contract 75D30125R73235 issued by the Centers for Disease Control and Prevention (CDC) for serological assay services for influenza virus detection. The amendment extends deadlines for proposals and updates testing schedules while maintaining all other terms unchanged. It establishes a contract structure comprising a base period and four additional option periods, focusing on sample testing and development of new serology assays, with the goal of enhancing influenza virus characterization. The contractor is responsible for conducting high-throughput testing of human samples, utilizing government-furnished materials and adhering to performance benchmarks outlined in the contract. The document emphasizes the importance of quality control throughout the assays and detailed reporting requirements while allowing for surge support in response to increased testing demands. Furthermore, it stipulates compliance with the Service Contract Act and outlines travel reimbursement guidelines. The purpose of this contract is to bolster the CDC's influenza surveillance capabilities through improved assay development and testing methodologies. Overall, it is a critical procurement effort to enhance public health response capabilities regarding influenza threats.
The document outlines an amendment to the solicitation 75D30125R73235, issued by the Centers for Disease Control and Prevention (CDC) for a contract aimed at providing serological assays for influenza virus detection and characterization. The amendment modifies the solicitation process, including updates to Federal Acquisition Regulation clauses, revised dates, and clarifications on Phase I requirements. It establishes a firm-fixed-price contract with optional cost-plus fixed-fee tasks spanning a base period and four subsequent option periods. The contract focuses on performing hemagglutination inhibition (HAI) assays on approximately 6,000 human serum samples annually, with provisions for increased testing capacity during outbreaks. It includes requirements for SOP development, proficiency testing, sample management, and the creation of reports on testing results. Optional tasks aim to develop new serology assays that could enhance testing capabilities. Key government-furnished materials will support testing and validation, while the contractor is responsible for quality assurance and compliance with safety regulations. The document reinforces the commitment to utilizing performance-based acquisition methods, ensuring the effective oversight of public health through improved influenza surveillance.
The document outlines an amendment to the solicitation 75D30125R73235, issued by the Centers for Disease Control and Prevention (CDC) for a contract aimed at providing serological assays for influenza virus detection and characterization. The amendment modifies the solicitation process, including updates to Federal Acquisition Regulation clauses, revised dates, and clarifications on Phase I requirements. It establishes a firm-fixed-price contract with optional cost-plus fixed-fee tasks spanning a base period and four subsequent option periods. The contract focuses on performing hemagglutination inhibition (HAI) assays on approximately 6,000 human serum samples annually, with provisions for increased testing capacity during outbreaks. It includes requirements for SOP development, proficiency testing, sample management, and the creation of reports on testing results. Optional tasks aim to develop new serology assays that could enhance testing capabilities. Key government-furnished materials will support testing and validation, while the contractor is responsible for quality assurance and compliance with safety regulations. The document reinforces the commitment to utilizing performance-based acquisition methods, ensuring the effective oversight of public health through improved influenza surveillance.
Apr 15, 2025, 4:05 PM UTC
The document outlines Amendment 2 of solicitation 75D30125R73235 from the Centers for Disease Control and Prevention (CDC) for contract services focused on developing and verifying serological assays for influenza virus detection and characterization. The contract emphasizes a competitive procurement approach with firm-fixed-price and cost-plus-fixed-fee tasks. Key components include providing sample testing services, with an estimated 6,000 tests per year, and optional surge capacities to handle higher volumes as needed. The performance work statement details the responsibilities surrounding the serological assays, including standard operating procedure (SOP) development, proficiency panel testing, and results reporting. It specifies both core and optional tasks, with timelines for periodic reporting and meeting engagements. The contractor's accountability in project management is highlighted, ensuring compliance with quality standards and timely communication with the government. Additionally, the document stresses the importance of using efficient travel practices and outlines potential travel requirements associated with training. The overarching aim is to enhance influenza surveillance capabilities while adhering to federal regulations and best practices, thus reflecting the CDC's commitment to public health and safety through scientific collaboration.
The document outlines Amendment 2 of solicitation 75D30125R73235 from the Centers for Disease Control and Prevention (CDC) for contract services focused on developing and verifying serological assays for influenza virus detection and characterization. The contract emphasizes a competitive procurement approach with firm-fixed-price and cost-plus-fixed-fee tasks. Key components include providing sample testing services, with an estimated 6,000 tests per year, and optional surge capacities to handle higher volumes as needed. The performance work statement details the responsibilities surrounding the serological assays, including standard operating procedure (SOP) development, proficiency panel testing, and results reporting. It specifies both core and optional tasks, with timelines for periodic reporting and meeting engagements. The contractor's accountability in project management is highlighted, ensuring compliance with quality standards and timely communication with the government. Additionally, the document stresses the importance of using efficient travel practices and outlines potential travel requirements associated with training. The overarching aim is to enhance influenza surveillance capabilities while adhering to federal regulations and best practices, thus reflecting the CDC's commitment to public health and safety through scientific collaboration.
Apr 15, 2025, 4:05 PM UTC
This document serves as Amendment 4 to the solicitation numbered 75D30125R73235, issued by the Office of Acquisition Services, effective from April 15, 2025. The amendment includes key modifications to the solicitation process, specifically suspending the solicitation until further notice, and updating the point of contact (POC) to Vic Veguilla, while removing Jennifer Gartzke from that role. The evaluation of Phase I will continue as samples are received, but vendors are exempt from submitting results concerning specific positive controls—B/Yamagata and B/Victoria. Notably, the advancement into Phase II has been suspended until further notice. All other terms of the solicitation remain unchanged. This amendment emphasizes procedural updates in the context of government RFPs, ensuring compliance and clarity for potential offerors regarding submission requirements and points of contact amidst changing evaluation conditions.
Apr 15, 2025, 4:05 PM UTC
The document outlines a government solicitation for a contract with the Centers for Disease Control and Prevention (CDC) to provide serological assays for the detection and characterization of influenza viruses. The contract spans a base period of one year starting June 4, 2025, with four optional extension periods. The core tasks include performing hemagglutination inhibition (HAI) assays to analyze human serum samples and developing new serology assays. Companies may also implement optional "surge support" testing to respond to unexpected demand. The contract requires compliance with various government regulations, including travel and operational safety standards. The contractor must meet performance-based metrics, such as maintaining high accuracy and timely reporting of results. Deliverables include technical reports, training of CDC staff on assay protocols, and regular status updates. Overall, the document serves as a formal request for proposals, emphasizing the need for high-throughput testing capabilities in response to ongoing public health challenges associated with influenza surveillance and vaccine effectiveness studies. The government is focused on achieving efficient, reliable testing services while fostering innovation in serological assay methods.
Apr 15, 2025, 4:05 PM UTC
The document addresses technical questions regarding a proficiency panel related to serology testing, specifically using the hemagglutination inhibition assay (HAI). It details that the panel will consist of 20 test samples, including both positive and negative controls, and will feature three individual antigens that need separate testing. The primary objective is to determine serum titers against these antigens, with a requirement for back titration of the antigens to confirm their concentration in hemagglutination units (HAU). The matching seroconversion rate is defined by a 4-fold rise in paired samples, and laboratories must report viral titers, calibrated against a strain specified by the CDC. The document also indicates a preference for using turkey red blood cells for testing. This inquiry and response format highlights the specificity required in government RFPs related to public health testing standards and emphasizes compliance and clarity in protocol to ensure effective results from the proficiency panel.
Lifecycle
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