Swedish Resource Center for Laboratory Diagnostics

Purpose and goal

The aim has been to develop a service center for evaluation and implementation of new or improved laboratory diagnostics. Evaluation of the service center has been conducted in collaboration with industrial customers in pilot projects for the validation of diagnostic tests and analysis systems. The Service center has been established and the function and the demand for the service have been shown by providing service to pilot customers.

Expected results and effects

Project agreements and business plan were designed and approved. A risk and impact assessment was carried out. New information model to link clinical data and analysis data to biobanked samples were produced. Service to pilot customer on an automated Pap smear test were conducted, including equipment installation, training of personnel, collecting the samples from biobanks and laboratory analysis . Demand for the service was larger than expected. Logistics took longer than planned, but could be implemented.

Planned approach and implementation

Localization, facilities and financial management model within the county took longer than expected. The majority of customers have been multinational companies with Swedish subsidiaries, where contractual matters also needed to be presented for the central management that has examined the regulatory and business aspects. The unit operates according to Good Laboratory Practice and Good Clinical Practice. Only SRCLDs personnel have access. We now have a functioning unit with processes, premises and personnel in place.