These specimens are acquired, validated, processed, stored and distributed to academic or private research end-users by professional biobanks, but with no established process to certify their characteristics, in particular the diagnosis. and specimen-related processing (also referred to as preanalytical) information. Relevant annotations for one biospecimen often concern information obtained on a paired but different type of specimen. Recently, the essential preanalytical variables, according to the types of biospecimens collected, were defined and their reporting was standardized.3C5 Accurate clinical, biological, and anatomo-pathological annotations, as well as precise preanalytical documents are required, especially by diagnostic and pharmaceutical industry end-users, in order to avoid artifactual biomarkers and false discoveries.6 Until now, Certified Reference Materials (CRM) have essentially concerned pure Daidzein chemical substances, certified for their Daidzein purity and concentration (Table 1). Reference Material (RM) producers must comply with ISO Guide 34 requirements,7 which cover production planning, homogeneity, stability testing, and value assignment (Table 1), calculation of the total uncertainty of the assigned value, issue of a certificate, and post-distribution service. Value assignment typically requires testing Daidzein by an accredited laboratory. However, certification of a clinical biospecimen corresponds, not to the characteristics of the material, but mainly to its original clinical, biological, and pathological diagnosis. In this context, the focus of certification is not the chemical substance, but the clinical origin of the material. Therefore, application of ISO Guide 34 to biospecimens certified for a clinical nominal property (Table 1) implies a fundamental shift from the substance purity to diagnostic accuracy and related biospecimen characterization. Definition of a biospecimen as Reference Material would require accurate information on the following parameters: processing, purity, characterization, Rabbit Polyclonal to Cyclin H (phospho-Thr315) fitness-for-purpose, homogeneity, and stability. Characterization concerns both the specimen originating case (diagnosis based on clinical, biological, or histopathological characteristics) and the biospecimen itself (molecular and cellular characteristics). Table 1. Definitions According to Draft ISO Guide 30:2013 (Reference MaterialsSelected Terms and Definitions) Reference MaterialMaterial, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement processCertified Reference MaterialRM characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that states the value of the specified property, its associated uncertainty, and a statement of metrological traceabilityCharacterization of a RMDetermination of the property values or attributes of a reference material, as part of the production processValue assignmentProcess by which RM property values or attributes obtained by characterization are combined and Daidzein expressed in accompanying RM documentationProperty value of a RMValue corresponding to a quantity representing a physical, chemical or biological property of a [certified] reference materialNominal property value of a RMValue corresponding to a qualitative attribute representing a physical, chemical or biological property of a [certified] reference material Open in a separate window The question we are trying to answer in this article is if and how clinical biospecimens can become Daidzein Reference Materials (RMs), certified for a nominal property, according to ISO Guide 34.7,8 Clinical Biospecimen Examples, as Reference Materials, Potentially Certified for a Nominal Property Acute infection serum (Example A) The bacterial sexually transmitted infection (STI) pathogen can cause serious reproductive complications such as pelvic inflammatory disease, ectopic pregnancies, and tubal infertility. Serological diagnostic tests are important in measuring past and current infection with genital chlamydial infection in assessment of women presenting to infertility clinics. Assessment of the performance of a serological assay for chlamydial infection is based on analysis of serum samples, collected.