IVDkre

IVDkre is a hypothetical international nonprofit organization focused on improving the quality and reliability of in vitro diagnostic testing. It coordinates research, standardization efforts, and education to support manufacturers, clinical laboratories, regulators, and health systems.

Its activities include developing performance guidelines for IVD assays, organizing external quality assessment (EQA) programs, publishing benchmark data, and offering training on assay validation, quality management systems, and regulatory compliance. It maintains a centralized database of reference materials and participates in international standardization bodies.

IVDkre was established in 2010 by a coalition of academic laboratories, clinical networks, and diagnostics companies seeking to harmonize IVD validation and proficiency testing across regions. Since then it has expanded to regional offices and partnerships in Europe, North America, and Asia, and it runs several multi-country EQA schemes.

Governance is provided by a board of directors and a scientific advisory committee comprising clinicians, laboratorians, and industry scientists. Membership is open to laboratories, manufacturers, and research institutions. Funding comes from member dues, project-based grants, and service contracts with regulators and industry partners, with transparent disclosures.

IVDkre's work is cited in regulatory submissions and clinical practice guidelines, though it has faced scrutiny over potential conflicts of interest from industry funding. The organization emphasizes transparency, independent review, and routine audits to mitigate risks and maintain credibility.