B08_Attachment_A_Specifications.docx

SECTION C – DESCRIPTION / SPECIFICATIONS

C.1 Scope The contractor shall furnish all necessary labor, materials, reagents, consumables, documentation, packaging, and shipping required to provide NAHLN‑compliant Cervid Spongiform Disease (CSD) / Chronic Wasting Disease (CWD) ELISA diagnostic test kits used for the screening of cervid tissues. All products shall meet or exceed the requirements outlined below.

C.2 Background The National Animal Health Laboratory Network (NAHLN) requires high‑throughput, validated ELISA assays for the detection of abnormal prion protein associated with Chronic Wasting Disease (CWD) in cervid samples. These tests are used for surveillance, herd certification, and diagnostic screening. The USGS requires NAHLN‑approved ELISA kits suitable for processing retropharyngeal lymph nodes (RPLN) and obex tissues under established laboratory workflows.

C.3 Applicable Documents The following references are applicable to performance under this contract:

- NAHLN Laboratory Approval Requirements – CWD ELISA (current version)

- USDA‑APHIS Chronic Wasting Disease Program Standards

- Manufacturer instructions for use (IFU)

- Material Safety Data Sheets (SDS) for all reagents C.4 Technical Requirements

C.4.1 Assay Type The assay shall be an Enzyme‑Linked Immunosorbent Assay (ELISA) capable of detecting misfolded prion protein (PrP^res) associated with CWD in cervid tissues. The assay must be validated for subspecies including white‑tailed deer, mule deer, elk, and moose.

C.4.2 Specimen Compatibility The ELISA kit shall be validated for the following tissue types:

- Retropharyngeal lymph nodes (RPLN)

- Obex Manufacturers must supply validated protocols covering both matrices.

C.4.3 Performance Requirements The assay must meet or exceed the following minimum performance characteristics:

- Diagnostic sensitivity: ≥ 95%

- Diagnostic specificity: ≥ 98%

- Repeatability: CV < 15% within a single run

- Reproducibility: CV < 20% across runs Performance data shall be provided upon request.

C.4.4 Kit Components Each kit shall include all necessary reagents to run a full 96‑well plate or other specified format, including:

- Coated ELISA microplates

- Positive and negative controls

- Enzyme conjugate

- Substrate (e.g., TMB)

- Wash buffer

- Stop solution

- Detailed assay instructions

- Lot‑specific Certificate of Analysis C.4.5 Laboratory Compatibility Kits must be compatible with standard laboratory equipment including:

- Microplate readers (450–620 nm)

- Standard pipettes and multichannel pipettes

- NAHLN biosafety workflows No proprietary equipment may be required for operation.

C.4.6 Throughput Requirements Kits must support high‑throughput laboratory processing (≥ 90 samples per plate). Assay run time shall not exceed 4 hours total.

C.4.7 Packaging, Storage, and Stability Minimum remaining shelf life at delivery: 6 months. Storage: 2–8°C. Kits must ship in insulated containers with temperature control.

C.4.8 Quality Assurance The contractor shall provide lot‑specific Certificates of Analysis, notify the Government of product recalls, and maintain GMP/ISO‑compliant quality systems.

C.5 Deliverables The contractor shall deliver:

1. NAHLN‑validated CSD/CWD ELISA kits

2. Electronic copy of instructions for use (IFU)

3. Lot‑specific quality documentation

4. SDS for all reagents

5. Packing slip with itemized content and lot numbers C.6 Shipping Materials shall ship under temperature‑controlled conditions and arrive during normal receiving hours. Compromised shipments shall be replaced at no cost.

C.7 Warranty The contractor shall replace any defective or non‑conforming kits at no additional cost to the Government.

C.8 Customer Support The contractor shall provide technical assistance, troubleshooting, and updates to testing protocols as needed.