Analysis of dried blood spots from a clinical trial in Mali

Amendment #1 Response to Questions: 1. Scope of work Will the testing lab receive only samples for analysis or do services include sample collection and shipment materials, Site materials such as a lab manual, and logistical support for sample shipments? Q1. If services include sample collection materials will this require all samples collected or just the dry blood spot collection supplies? A1. The testing lab will only receive the samples- no sample collection. Q2. Is the total number of analysis 2000 samples. Does this breakdown in a manner such as 80 subjects with sample collections bi-weekly for a 1 year period. A2. The samples will be screened on a rolling basis as the length of study is 1-2 years (FY 25-26) Q3. Are there any special requirements for analysis of samples, example- all samples for a single subject tested in a single batch. A3. No, samples can be tested in multiple batches Testing information Q4. Is there the potential to receive information on a preferred testing platform, sample extraction platform or reagent. A4. We cannot provide information on the protocol currently being used. Note: The response date for capability statements has been extended to Friday, May 23, 2025 at 11:00 AM.. THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS. This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b)(2) and 13.501(a) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive quotes. The National Institute of Allergy and Infectious Diseases (NIAID), intends to negotiate on a sole source basis with University of Washington, 4333 Brooklyn Avenue, NE, Box 359472, Seattle, WA 98195 to perform qRT-PCR Testing analysis on approximately 2000 Samples for the Malaria Infection Biology and Immunity Unit's L9LS monoclonal antibody clinical trial on an other than full and open competition basis. The services to be provide are the following: Description of need: - qRT-PCR Testing analysis; batched Mali blood sample testing submission (approx. 2000) per samples - Billing to be monthly or quarterly in arrears Period of Performance: 7/01/2025 - 06/30/2026 Place of Performance: Rockville, MD 20852 The National Institute of Allergy and Infectious Diseases (NIAID), Laboratory of Immunogenetics (LIG), is a specialized research facility dedicated to understanding the genetic basis of the immune system. It integrates the fields of immunology and genetics to explore how genetic variations influence immune responses, disease susceptibility, and the effectiveness of treatments. The LIG's mission is to advance the understanding of immunogenetics through cutting-edge research and innovation. Some key objectives include identifying genetic factors, understanding disease mechanisms, developing therapeutics, improving diagnostics, and promoting personalized medicine. Antibodies are known to play a critical role in protection against liver- and blood-stage parasites. This study is testing the efficacy of a monoclonal antibody to protect against malaria infection in several clinical trials on-going in Mali in for protection from infection of p. Falciparum in adults, children, and infants. After administration of antibodies or placebo, every 2 weeks the participants come to the clinic for blood draws and blood spots are applied to filter paper. These blood spots need to be analyzed by qRT-PCR, to detect very small amounts of parasites to determine if the participant is infected with Plasmodium Falciparum. Using quantitative (qRT-PCR) is a very sensitive method of determining low levels of infection. The University of Washington laboratory performs the only qRT-PCR assay for the detection and quantification of Plasmodium parasites that has received the Drug Development Tool Biomarker Qualification through the FDA. Their qRT-PCR assay is recognized as among the most sensitive and robust molecular diagnostic assays for malaria in the world, allowing for the detection of malaria parasites in human blood up to 3-4 days earlier than by conventional blood smears and at parasite densities that are undetectable by conventional methods and by other DNA-based molecular tests. Use of this specific assay ensures quantitative and qualitative comparability across cohorts and trails. The laboratory ensures internal and external quality assurance for all results. Only one award will be made as a result of this notice. This will be awarded as a firm-fixed price purchase order. The period of performance for full performance is July 1, 2025 to June 30, 2026. The North American Industry Classification (NAICS) code for this acquisition is 541380 - Testing Laboratories and Services standard of $19.0 M. This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within 15 days of this notice. The statutory authority for this sole source requirement is 41 U.S.C. 253(c)(1) as implemented by FAR 6.302-1 (b)(1)(i) only one source available, no substitutions possible. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. All responsible sources who can provide the service should submit a capability statement via email to Linda Smith at Linda.Smith2@nih.gov by 11:00am EST on May 23, 2025. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Any responses received by NIAID after this date and exact time specified are late and will not be considered. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Linda Smith, Contract Specialist at Linda.smith2@nih.gov.