Molecular diagnostics is one of the most rapidly growing areas of laboratory medicine. This rapid growth of clinical molecular tests has outpaced the availability and development of reference methods and reference materials. Such methods and materials are important for the development, validation, and interpretation of diagnostic methods and tests. Yet, there is a lack of harmonization between the numerous international organizations currently either certifying or defining reference materials. The objective of this position paper is to review and clarify the definition, attributes and applications for the use of reference materials in the context of molecular diagnostics.

Calibrator, Control, DNA, Genes, Quality, Quality assurance, Reference materials, Validation, accuracy, apparatus, article, calibration, equipment and supplies, gene sequence, genotype, molecular diagnosis, nucleic acid analysis, nucleic acid reference material, priority journal, quality control, quantitative analysis, single nucleotide polymorphism, standardization, validation process,
Clinical Chemistry and Laboratory Medicine: Associated with FESCC and IFCC
Erasmus MC: University Medical Center Rotterdam

Payne, D.A, Mamotte, C.D.S, Gancberg, D, Pazzagli, M, van Schaik, R.H.N, Schimmel, H, & Rousseau, M.F. (2010). Nucleic acid reference materials (NARMs): Definitions and issues. Clinical Chemistry and Laboratory Medicine: Associated with FESCC and IFCC, 48(11), 1531–1535. doi:10.1515/CCLM.2010.313