Notice of Intent to Sole Source – LGC Diagnostics

The National Institutes of Health (NIH) intends to award a fixed price purchase order to LGC Clinical Diagnostics Inc. for the provision of LGC HIV-1 and Hepatitis C Virus (HCV) validation panels. These panels are required for the analytical and clinical validation of the Roche cobas 5800 molecular diagnostic system. The panels consist of highly characterized and traceable viral materials that are commutable and appropriate for nucleic acid amplification testing. • The panels span clinically relevant viral load concentrations across the analytical measurement range of the Roche assays. • LGC provides comprehensive documentation, including certificates of analysis and stability data. • Alternative commercial products were evaluated and determined to be unsuitable due to lack of characterization, traceability, documentation, or concentration range required for full assay validation.