Regulatory, Technical and manufacturing support for a diagnostic test

Tender description

The University is seeking expressions of interest from suppliers who can provide Regulatory, manufacturing and technical support to the NEOSEPSIS project for the purpose of making a competitive serum amyloid A (SAA) lateral flow test available as a sepsis diagnostic in Uganda and Low-Middle Income countries to prevent neonatal and maternal deaths. The NEOSEPSIS project proposes to use the NeoSep SAA test to reduce neonatal and maternal mortality by rapid detection of sepsis in Low-Middle Income Countries. This solution will be delivered by implementing the test in hospitals, health facilities and non-hospital environments in Uganda for the rapid detection of neonatal and maternal sepsis. At present, clinical evaluations have been completed to evaluate the performance of the NeoSep SAA test in both hospital and non-hospital settings. Statistical analysis of data collected, clearly indicates that the test has proved successful in both settings and the results have been published. The next key steps for deployment of the solution, which are underway, is to undertake essential extra clinical evaluations in Uganda, progress the registration of the NeoSep SAA test in Uganda, implement a process for manufacturing and supply of the NeoSep-SAA kit and develop a clear plan for supply and distribution of the test initially into the Ugandan market. Qualifications and Previous Experience: Applicant companies must have a Quality Management System in place (e.g., ISO9000). Applicant companies must have experience in development, manufacture and supply of competitive lateral flow tests to detect human serum amyloid A. Applicant companies must be capable of supporting technology transfer of lateral flow test systems. Ideally, applicant companies should be able to demonstrate adaptation of lateral flow tests for quantitative analyte detection.