Inactive

The Centers for Disease Control and Prevention (CDC) intends to award a sole source firm fixed priced simplified purchase order to Cellex, Inc to procure qSARS-CoV-2 IgG/IgM Rapid Test, 25 tests/kit. ... The Centers for Disease Control and Prevention (CDC) intends to award a sole source firm fixed priced simplified purchase order to Cellex, Inc to procure qSARS-CoV-2 IgG/IgM Rapid Test, 25 tests/kit. With the global pandemic of COVID-19, Cellex qSARS-CoV-2 IgG/IgM Rapid Test kits are immediately needed to continue the evaluation of COVID-19 antibody tests for seroprevalence surveys and use at point of care testing sites. Results from this evaluation will guide all settings, domestic and international, on use of these kits for detection of SARS-CoV-2 antibody especially in remote and hard to reach populations. During this new and global pandemic, and without any prior research in this area, the results will provide surveys and point of care testing sites an alternative for high quality testing. Cellex is the only known commercial biotech company that supplies the qSARS-CoV-2 IgG/IgM Rapid Test kits. The Cellex qSARS-CoV-2 IgG/IgM Rapid Test kits will be used in an ongoing project and the consistency in using test kits with similar target antigens and biological principles are needed to ensure quality of data. The selection of the Cellex qSARS-CoV-2 IgG/IgM Rapid Test kits was based on that fact that it has been approved for Emergency Use Authorization by the FDA (FDA-EUA only). Additional requirements we used to select the test kit was similar antigen targets from the spike S protein, human serum or plasma samples types and anticoagulants used as well as its application in resource limited settings. Therefore, use of this kit in generating data is critical to ensure the quality of data as it is being used for SARS-CoV-2 rapid test validation. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) (SAP) and 41 U.S.C. 3304(c)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within seven (7) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation /response should be emailed to the Contracting Specialist at lsf7@cdc.gov (CTR) by 4:00PM EST on 08-06-2021. No telephonic quotes shall be considered.