Harmonization of units and reference intervals of plasma proteins: state of the art from an External Quality Assessment Scheme.

BACKGROUND: The need to harmonize laboratory information is particularly intense in the field of plasma proteins, considering their clinical impact and relevance in monitoring diseases. METHODS: We evaluated units and reference intervals (RIs) utilized by participants of the External Quality Assessment Scheme (EQAS) for plasma proteins of the Centre of Biomedical Research. Moreover, we evaluated inter-laboratory analytical variability from 2001 to 2017. RESULTS: The census of participants' units employed in 2017 showed that for albumin (ALB), ~66% of laboratories still used dL instead of L, and for most other proteins, ~70% still expressed the results in mg/dL. Laboratories primarily used the RIs reported in the packaging inserts of their analytical systems, but for each protein, there was a wide variability of RIs, also among laboratories using the same analytical method. Mean CVs% of the 13 certified proteins in the last five EQA cycles ranged from 3.8% of haptoglobin (HPT) to 12.4% of α1-antitrypsin (AAT) and decreased from 2001 to 2017 for most of them, in particular for C3, ALB, α2-macroglobulin (A2M), HPT and transferrin (TRF). CONCLUSIONS: In the face of a reduction in inter-laboratory variability for a lot of proteins, there has not been a substantial change in the units and in the RIs used by the participants. To change old habits is difficult and requires coordination and collaboration. The EQAS plays an important role in the assessment and monitoring of all elements that contribute to the formulation of laboratory information and may be useful to contribute to their harmonization.

Standards for plasma and serum proteomics in early cancer detection: a needs assessment report from the national institute of standards and technology--National Cancer Institute Standards, Methods, Assays, Reagents and Technologies Workshop, August 18-19, 2005.

NIST and the National Cancer Institute cosponsored a workshop on August 18-19, 2005, to examine needs for reference materials for early cancer detection. This meeting focused on standards, methods, assays, reagents, and technologies. Needs for plasma and serum proteomics, DNA methylation, and specimen reference collections were discussed, and recommendations from participants were solicited. This report summarizes the discussion and recommendations for proteomics reference materials.

Research and development commitments in an integrated plasma collection and plasma fractionation environment.

Plasma fractionation has emerged as one of the most scientifically demanding fields in the biopharmaceutical area. Producing safe plasma derivatives implies the development, use, and proper understanding of sensitive testing technologies to detect infection markers in starting plasma. It also requires the implementation of carefully selected, nondenaturing, efficient plasma protein purification and viral reduction technologies that do not alter the physiological functions and clinical potential of plasma proteins. Success in this field can be achieved only by a strong commitment to sustain constant research and development of projects targeting the production of safer and innovative plasma products.

Is self-sufficiency financially viable and ethically justifiable?--the role of the National Blood Authority.

The National Blood Authority is committed to the principle of self-sufficiency but also supports the principle of clinical freedom and aims to improve patient care. Methods of increasing plasma yields are being investigated. On-going discussions are being held with the commercial sector concerning the range of products available and methods of improving manufacturing efficiency. It is believed that the NBA can become largely self-sufficient using blood given by the 2,000,000 voluntary donors.

European regulatory issues.

Current EU regulations do not cover all aspects of the manufacture and control of blood products. Recent legislation coming into force on 1 January 1995 has established the European Medicines Evaluation Agency and introduced revised systems for approving pharmaceutical products, including blood products. There remains a need for comprehensive harmonized legislation covering plasma collection and screening, virus validation studies, and batch release.