Provision of Non-Invasive Pre-Natal Testing Service

The St George's Antenatal Fetal Evaluation (SAFE) test is a Non Invasive Prenatal Testing (NIPT) service based at St George's University Hospitals NHS Foundation Trust, screening for Down's, Edwards' and Patau's syndromes, in line with UK National Screening Committee (UKNSC) recommendations and NHS England requirements. In some instances, fetal sexing is performed in addition to the main trisomy's. The SAFE test has been set up as a collaboration between the Fetal Medicine Unit and the St George's Genomics Service, which is a UKAS accredited medical laboratory. The service provides NIPT to approximately one third of the NHS maternity services in England and several private clinical services performing 4,000-5,000 tests annually. This invitation to tender gives the requirement to supply a complete laboratory test setup including reagent test kits for NIPT, all equipment, associated software and LIMS and equipment servicing. The test should be commercially available and CE marked for In Vitro diagnostic use ideally compliant to ISO13485. It should detect aneuploidy of chromosomes 13, 18 and 21 and be able to determine fetal sex within the specified sensitivity and specificity thresholds as a minimum requirement. The supplier must provide reagents, software and protocols sufficient to produce an end result on suitable equipment designated by the supplier. Resulting data must be clearly reportable and be usable by The SAFE Test personnel in a flexible and secure manner. The service must be provided to diagnostic standards, incorporating a complete CE/IVDD compliant workflow, to ensure data can be used for clinical interpretation. Samples must be analysed within the given timeframe, data must meet the minimum specified requirements and results issued in a customisable and easily interpretable format. The majority of samples processed are commissioned by NHSE with a contract running until March 2026. In the event St George's is not re-procured by NHSE to provide this service beyond this point, it is likely that the service may have to terminate its contract with the supplier.