Description
The Centers for Disease Control and Prevention (CDC) is seeking a contractor to design and produce 4000 lateral flow strips for the rapid HIV nucleic acid diagnostic test. The contractor will be responsible for designing and validating the lateral flow strips, which must meet specific requirements, including being highly specific with low false positive and false negative rates. The contractor will also be required to deliver prototype lateral flow strips for evaluation and provide final design specifications for scale-up. The period of performance is from August 1, 2026, to December 31, 2026.
• The contractor must have experience in designing biomedical devices and the FDA approval process.
• The contractor must provide a plan for design, optimization, and validation of the lateral flow strips.
• The contractor must deliver 200 prototype lateral flow strips for evaluation.
• The contractor must provide final design specifications for scale-up.
• The contractor must comply with Section 508 accessibility standards.