JA Qiagen QFT FINAL 9-4-25 _Redacted.pdf

This Justification Review Document for FAR Part 13 details a non-competitive five-year firm fixed price contract for QuantiFERON TB Gold-Plus assays with Qiagen, LLC. The contract is for the Madigan Army Medical Center's Department of Pathology at Joint Base Lewis-McChord in Tacoma, WA, with a total contract ceiling of $480,000 and an ordering period through September 30, 2030. The assays are specifically for detecting Mycobacterium tuberculosis immune responses by enzyme immunoassay (EIA), with the goal of early TB infection detection in low prevalence populations, particularly within the military and surrounding communities.

The document emphasizes that the QuantiFERON TB Gold-Plus test is the only FDA-cleared interferon-gamma release assay that can be used on the DiaSorin LIAISON XL analyzer at MAMC without requiring additional instrumentation. Market research conducted within the past 12 months revealed no alternative sources capable of meeting the government's specific requirements. The contract aims to ensure continuous laboratory operations, maintain required testing capacity, and meet Defense Health Agency (DHA) reference laboratory obligations, with the assay capable of processing at least 200 samples to support uninterrupted operations and provide timely results.