Chronic Wasting Disease (CWD) ELISA Test Kits

The U.S. Geological Survey (USGS) requires NAHLN-compliant Enzyme-Linked Immunosorbent Assay (ELISA) test kits for the detection of abnormal prion protein associated with Chronic Wasting Disease (CWD) in cervid tissues. These kits will be used for surveillance, herd certification, and diagnostic screening. The assay must be validated for white-tailed deer, mule deer, elk, and moose, and compatible with retropharyngeal lymph nodes (RPLN) and obex tissues. Key performance requirements include a diagnostic sensitivity of 95% and diagnostic specificity of 98%. Each kit must include all necessary reagents for a 96-well plate, be compatible with standard laboratory equipment, and support high-throughput processing with an assay run time not exceeding 4 hours. Kits must have a minimum remaining shelf life of 6 months upon delivery and be stored at 2-8degC, shipped in temperature-controlled containers. The contractor must provide lot-specific Certificates of Analysis, notify the government of product recalls, and maintain GMP/ISO-compliant quality systems. Deliverables include the ELISA kits, instructions for use, quality documentation, Safety Data Sheets (SDS), and a packing slip. The period of performance is estimated to be from June 1, 2026, to May 31, 2031, with an overall not-to-exceed value of $200,000.00.