Laboratory Testing Services to perform qRT-PCR on human blood samples

PRE-SOLICITATION NOTICE NOI-NIAID-2088521 NAICS - 541380 This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with the University of Washington School of Medicine to procure qRT-PCR on human blood samples collected over the course of a monoclonal antibody clinical trial in Mali. The University of Washington laboratory performs the only qRT-PCR assay for the detection and quantification of Plasmodium parasites that has received Drug Development Tool Biomarker Qualification through the U.S. 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. The analytical limit of detection for dried blood spots is 20-100 estimated P. falciparum parasites/ml. Their qRT-PCR assay uses a contact-free laser cutting system that effectively eliminates cross-contamination during dried blood spot processing. Their assay validation data demonstrated that the TaqMan probe-based assay on the Abbott m2000 automated extraction/amplification platform is highly sensitive and specific across a wide range of parasite densities for dried blood spot samples. The University of Washington laboratory is actively working with FDA to further expand the qualified context of use for this assay including for use in endemic field studies. The assay has been validated with respect to accuracy, correlation, precision, analytical sensitivity, analytical specificity, and carryover The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2088521 to Dana Monroe at contact@example.gov, by 5:00 pm eastern standard time Wednesday, September 8, 2021. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.