Procurement of lateral flow cassettes for the rapid HIV nucleic acid diagnostic test

The contractor, a commercial medical device company, will produce 2000 lateral flow devices and supporting plastic consumables meeting specifications: reaction tube must be RNase/DNase free and lock to prevent re-opening; cap must interface seamlessly with the cassette and allow delivery of contents to the strip without leakage; all components must prevent environmental contamination; results must be reproducible. The contractor must deliver 100 prototypes per design for CDC evaluation, then 2000 final devices. Tasks include bi-weekly meetings, creating a Design History File, delivering prototypes within 7 months, final devices within 14 months, and final specifications within 15 months of contract start.