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

The Centers for Disease Control and Prevention (CDC) is seeking a contractor to design and produce 2000 lateral flow devices for the evaluation of a rapid HIV nucleic acid test. The test is based on loop-mediated isothermal amplification (LAMP) and requires a lateral flow device for detection. The contractor will be responsible for designing and validating the lateral flow cassettes, lateral flow strips, and reaction tubes, as well as producing the final devices. The contract will be for a period of 16 months, from September 1, 2026, to December 31, 2027. The contractor will need to deliver 100 prototype devices for testing and evaluation by the CDC, and then produce the final 2000 devices. The contractor will also need to provide documentation and support for the production of the devices. Key requirements include: • Design and validation of lateral flow cassettes, lateral flow strips, and reaction tubes • Production of 2000 lateral flow devices • Delivery of 100 prototype devices for testing and evaluation • Provision of documentation and support for production • Compliance with Section 508 accessibility standards The contractor will need to have experience in designing and producing lateral flow kits and will need to work closely with the CDC to ensure that the devices meet the required specifications.