Ireland – Laboratory, optical and precision equipments (excl. glasses) – VEAT notice for the supply, installation, validation, interfacing, staff training and maintenance of Nova StatStrip® glucose/ketone meters for the POCT determination of blood glucose and β-hydroxybutyrate.

The objective of this Voluntary Ex Ante Transparency (VEAT) notice is to inform the market of Tallaght University Hospital intention to enter into a contractual duration period with Nova Biomedical in accordance with Article 32.2(b) (i.e. the works, supplies or services can be provided only by a particular economic operator for any of the following reasons: (ii) competition is absent for technical reasons; (iii) the protection of exclusive rights, including property rights). For the supply, installation, validation, interfacing, staff training and maintenance of 146 handheld Nova StatStrip® dual functionality glucose/ketone meters for the POCT determination of approximately 261,000 blood glucose tests and 45,000 β-hydroxybutyrate tests per year. Supply of internal quality control sufficient for once-daily internal quality per meter. The meters will be fully interfaced to AQURE data management system for automatic upload of patient results, Operator ID, Device ID, QC results. The meter must have dual functionality suitable for the measurement of both blood β-hydroxybutyrate and glucose. It must be suitable for adult and paediatric clinical use and have a clinically appropriate measuring range for diagnosis and management of: Diabetic ketoacidosis (DKA) and ketosis. The meter must be CE-marked for in-vitro diagnostic (IVD) use (IVDR compliant where applicable) and compliant with relevant ISO standards (e.g. ISO 15197 or equivalent where applicable). The meter must be handheld, have dual glucose/ketone functionality be of robust design suitable for high-throughput clinical areas. It must have an easy-to-use interface with minimal training burden, barcode scanning or manual entry for patient/operator identification and clear display of results and flags for critical values. On-site or remote initial user training and super-user training must be provided along with provision of training materials (SOPs, IFUs, quick reference guides). Ongoing technical support and...