Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing

Holden, Marcia J.; Madej, Roberta; Minor, Philip D.; Kalman, Lisa V.

doi:10.1586/erm.11.50

Cited by 44 publications

(39 citation statements)

References 39 publications

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“…The proliferation of assay methods, mainly homemade, and the absence of standard reference materials contribute to variability in test results among laboratories. Harmonization initiatives are based on the development of reference materials, appropriate documentary standards and guidelines, and proficiency testing/external quality assessment programs [ 40 ]. The importance of harmonization, and its advantages over standardization, has been stressed for innovative biomarkers, particularly when ' broader implementation is premature or prohibitively expensive ' [ 41 ].…”

Section: Harmonization Of Laboratory Resultsmentioning

confidence: 99%

Harmonization in laboratory medicine: the complete picture

Plebani

2013

Clinical Chemistry and Laboratory Medicine (CCLM)

135

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Evidence of the acute lack of interchangeable laboratory results and consensus in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus is mainly on the standardization of measurement procedures, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference intervals and decision limits, as well as test profiles and criteria for the interpretation of results. This review provides further insight on the issue of harmonization in laboratory medicine in view of the urgent need for a complete picture now that old and new drivers are calling for more effective efforts in this field. The main drivers for standardization and harmonization projects are first and foremost patient safety, but also the increasing trends towards consolidation and networking of clinical laboratories, accreditation programs, clinical governance, and advances in Information Technology (IT), including the electronic patient record. The harmonization process, which should be considered a threetier approach involving local, national and international fronts, must go beyond the harmonization of methods and analytical results to include all other aspects of laboratory testing. A pertinent example of the importance of a complete picture in harmonization programs is given by the National Bone Health Alliance working in the field of bone turnover markers in cooperation with scientific societies including the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

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Section: Harmonization Of Laboratory Resultsmentioning

confidence: 99%

Harmonization in laboratory medicine: the complete picture

Plebani

2013

Clinical Chemistry and Laboratory Medicine (CCLM)

135

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“…These tests, in fact, are used to diagnose cancer, provide prognostic assessments, aid in treatment selection and monitor the effectiveness of therapy, also through the detection of minimal residual disease for a single patient. However, particularly in the field of nucleic acid testing for infectious diseases and clinical genetics, the proliferation of assay methods, the number of targets for molecular diagnostics and the absence of standard reference materials contribute to variability in test results among laboratories [62]. In particular, there is a lack of established and globally accepted reference materials to serve as primary standard for comparing performance characteristics and results performed in different laboratories and/or using different methods.…”

Section: Harmonization In Laboratory Medicine: Not Only Clinical Chemmentioning

confidence: 99%

“…In fact, it is increasingly important to harmonize quantitative assays assays, such as viral load measurements, and/or to establish the analytic sensitivity of qualitative assays. However, the availability of reference materials alone does not assure harmonization: reliable approaches for their implementation in test development and validation should be uniform according to guidelines, consensus documents, documentary standards and reference method publications [62]. In the last few years, the fast emergence and the great success of next-generation sequencing (NGS), allowing the fast generation of thousands to millions of base pairs of DNA sequence of an individual, herald a new era in molecular diagnostics.…”

Section: Harmonization In Laboratory Medicine: Not Only Clinical Chemmentioning

confidence: 99%

Harmonization in laboratory medicine: more than clinical chemistry?

Plebani

2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:The goal of harmonizing laboratory information is to contribute to quality in patient care, ultimately improving upon patient outcomes and safety. The main focus of harmonization and standardization initiatives has been on analytical processes within the laboratory walls, clinical chemistry tests in particular. However, two major evidences obtained in recent years show that harmonization should be promoted not only in the analytical phase but also in all steps of the testing process, encompassing the entire field of laboratory medicine, including innovative areas (e.g. "omics") rather than just conventional clinical chemistry tests. A large body of evidence demonstrates the vulnerability of the extra-analytical phases of the testing cycle. Because only "good biological samples" can assure good analytical quality, a closer interconnection between the different phases of the cycle is needed. In order to provide reliable and accurate laboratory information, harmonization activities should cover all steps of the cycle from the "pre-preanalytical" phase (right choice of test at right time for right patient) through the analytical steps (right results with right report) to the "post-post-analytical" steps (right and timely acknowledgment of laboratory information, right interpretation and utilization with any necessary advice as to what to do next with the information provided). In addition, modern clinical laboratories are performing a broad menu of hundreds of tests, covering both traditional and innovative subspecialties of the discipline. In addition, according to a centered viewpoint, harmonization initiatives should not be addressed exclusively to clinical chemistry tests but should also include all areas of laboratory medicine.

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“…However, viable microbe number represents a fundamentally different measure to nucleic acid quantity and the two may or may not be correlated. Large batch production of material offers alternatives, whether production is achieved by mixing known amounts of microbes or following the strategy used for matrix reference materials like water and soil or the world health organization (WHO) clinical international standards [16]. For metagenomics, large batches of real clinical/environmental samples are arguably the most suitable controls.…”

Section: Considerations For Developing Control Materials For Metagenomentioning

confidence: 99%

Considerations for the development and application of control materials to improve metagenomic microbial community profiling

Huggett¹,

Laver

Tamisak³

et al. 2012

Accred Qual Assur

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Advances in DNA sequencing technology provide the possibility to analyse and characterize the genetic material from microbial populations (the microbiome) as a whole. Such comprehensive analysis of a microbiome using these 'metagenomic' approaches offers the potential to understand industrial, clinical and environmental microbiology to a level of detail that is unfeasible using conventional molecular or culture-based methods. However, the complexity offered by metagenomic analysis is also the weakness of this method and poses considerable challenges during analytical standardisation. In this manuscript, we discuss options for developing control materials for metagenomic analysis and describe our preliminary work investigating how such materials can be used to assist metagenomic measurements. The control materials we have developed demonstrate that, when performing 16S rDNA sequencing, different library preparation methods (incorporating adapters before and after the PCR) and small primer mismatches can alter the reported metagenomic profile. These findings illustrate that metagenomic analysis can be heavily biased by the choice of method and underpin the need for control materials that can provide a useful tool in informing choice of protocol for accurate analysis.

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Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing

Cited by 44 publications

References 39 publications

Harmonization in laboratory medicine: the complete picture

Harmonization in laboratory medicine: the complete picture

Harmonization in laboratory medicine: more than clinical chemistry?

Considerations for the development and application of control materials to improve metagenomic microbial community profiling

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