The National Research Council, Human Health Therapeutics (NRC – HHT) requires a High Sensitivity Immunoassay Plate Reader capable of quantifying low-abundance biologics and biomarkers in complex biological matrices. The instrument must provide high sensitivity, broad dynamic range, multiplex capability, and compatibility with small sample volumes. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)
Any interested supplier must demonstrate by way of a statement of capabilities that its system meets the following performance-based requirements:
- Detect analytes at low picogram/mL concentrations.
- Provide a linear dynamic range spanning at least four orders of magnitude.
- Provide intra- and inter-assay precision with coefficient of variation (CV) = 10%.
- Be compatible with serum, cerebrospinal fluid, tissue lysates, and cell lysates.
- Support at least 96-well plates and load a minimum of three plates.
- Support multiplex analysis of multiple analytes in a single sample.
- Allow flexible assay design without requiring proprietary consumables.
- Provide data traceability including run logs and audit trails.
