HIV Diagnostic Loop-mediated isothermal AMPlification (LAMP) Assay with Lateral Flow readout

This is a presolicitation notice for an HIV Diagnostic Loop-mediated isothermal AMPlification (LAMP) Assay with Lateral Flow readout. The Centers for Disease Control and Prevention (CDC) is issuing this notice solely for informational and planning purposes. The government will not pay for any cost incurred in response to this notice. This procurement will be a total small business set-aside. The NAICS code is 339112 with a size standard of 1,000 employees. The CDC intends to award a firm-fixed-price purchase order for the requirement with a one-year period of performance. Place of performance will be at the vendor’s facility. A request for quote (RFQ) is expected to be available on sam.gov on or about 9/5/2023. The successful Vendor is expected to be an established engineering design firm and/or medical device company with the capabilities to manufacture prototype electronic heating modules and consumable plastics. The following provides a description of the effort: the Vendor shall design, manufacture, validate, and deliver ten reusable heating devices along with an assay tube and lateral flow device for diagnostic test readout. The Vendor shall be responsible for design and mechanical validation of the electronics, fluidics, and physical parts and containers of the whole device, including the heating module, power source and any plastic consumables that come from the design phase. The Vendor shall perform no less than three consecutive evaluation runs demonstrating consistent performance. The Vendor shall demonstrate successful alarm and recovery from forced faults, such as the reaction tube being inserted too long or removed prior to the completion of the specified reaction time. The CDC will provide technical assistance in designing the device and physical parts. The CDC will then evaluate the performance of the prototype device using its in-house developed LAMP assay with the goal of providing feedback within the contract period if a device revision is required. Device revisions may be required to fulfill the requirement. The Vendor shall collaborate with the HIV Diagnostics Team at the CDC during the performance period. Development shall occur at the Vendor’s facility with guidance from the CDC. Vendors must have an active sam.gov registration to be considered for award. Hard copies of the RFQ will not be available. No telephone or written requests for copies will be accepted.