Referenslaboratorier

Referenslaboratorier are specialized laboratories that provide authoritative testing, method development, and quality assurance to support the accuracy and comparability of laboratory results across health systems and industry. They typically operate at national, regional, or international levels and serve as centers for standardization, reference materials, and expert consultation.

The core functions of referenslaboratorier include the development and validation of reference methods, the production and dissemination of reference materials, and the establishment of traceability to recognized standards. They coordinate external quality assessment and inter-laboratory comparisons to ensure consistency of results across facilities. When new analytes or technologies emerge, referenslaboratorier may evaluate and validate methods before wider adoption and provide guidance to routine laboratories.

Organization and standards vary by country, but referenslaboratorier commonly operate under formal accreditation schemes such as ISO 15189 for medical laboratories or ISO/IEC 17025 for testing and calibration laboratories. National accreditation bodies, for example Sweden’s SWEDAC, oversee compliance and ensure laboratories meet required quality and competence criteria. In addition to accreditation, these laboratories often participate in international networks and programs run by organizations like the World Health Organization or regional health agencies to harmonize methods and reference materials.

Typical domains include clinical chemistry, microbiology, infectious disease testing, toxicology, and genetics, as well as specialized areas such as newborn screening or environmental testing. Through their work, referenslaboratorier support accurate diagnoses, enable comparability of results across laboratories, and help validate new tests and technologies, ultimately contributing to patient safety and public health.