Metrology in laboratory medicine – Reference measurement systems

2001 ◽  
Vol 6 (1) ◽  
pp. 16-19 ◽  
Author(s):  
R. Dybkaer
Keyword(s):  
Laboratory Medicine ◽  
Reference Measurement ◽  
Measurement Systems

Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?

2012 ◽  
Vol 50 (5) ◽  
Author(s):  
Mauro Panteghini ◽  
Ferruccio Ceriotti
Keyword(s):  
Reference Values ◽  
Reference System ◽  
Laboratory Medicine ◽  
Reference Intervals ◽  
Multicenter Studies ◽  
Reference Measurement ◽  
Measurement Systems ◽  
Experimental Protocols ◽  
Definition Of ◽  
Result Interpretation

AbstractAn issue associated with standardization efforts is the need to develop useful reference intervals (RI). Lack of proper RI may hamper the implementation of standardization in Laboratory Medicine as standardization can modify analyte results and, without adequate RI, this can impair the result interpretation. Once defined, RI obtained with analytical procedures that produce results traceable to the corresponding reference system can be transferred among laboratories, providing that they use commercial assays that produce results traceable to the same reference system and populations have the same characteristics. Multicenter studies are needed for a robust definition of traceable RI, using experimental protocols that include well defined prerequisites. Particularly, employed methods must produce results that are traceable to the reference system for that specific analyte. Thus, the trueness of laboratories producing reference values should be verified and, if necessary, experimental results corrected in accordance with correlation results with the selected reference. If requirements in the adoption of traceable RI are fulfilled, the possibility of providing RI that are applicable to any laboratory, able to produce results traceable to the reference system, is realistic. The definition of traceable RI should hopefully cause the disappearance of different RI employed for the same analyte, providing more effective information to clinicians.

Reference measurement systems in clinical chemistry

2002 ◽  
Vol 323 (1-2) ◽  
pp. 73-87 ◽  
Author(s):  
Linda M. Thienpont ◽  
Katleen Van Uytfanghe ◽  
André P. De Leenheer
Keyword(s):  
Clinical Chemistry ◽  
Reference Measurement ◽  
Measurement Systems

scholarly journals Traceability in Laboratory Medicine

2009 ◽  
Vol 55 (6) ◽  
pp. 1067-1075 ◽  
Author(s):  
Hubert W Vesper ◽  
Linda M Thienpont
Keyword(s):  
Metrological Traceability ◽  
Implementation Process ◽  
Laboratory Medicine ◽  
Regulatory Requirement ◽  
Measurement Systems ◽  
Measurement Results ◽  
Control And Prevention ◽  
Improving Patient Care ◽  
Laboratory Standardization ◽  
Traceability Of Measurement Results

Abstract Background: In patient and population samples, generation of analytical results that are comparable and independent of the measurement system, time, and location is essential for the utility of laboratory information supplied in healthcare. Obtaining analytical measurement results with such characteristics is the aim of traceability in laboratory medicine. As awareness of the benefits of having traceable measurement results has increased, associated efforts have been directed toward making traceability a regulatory requirement and developing approaches to enable and facilitate the implementation of traceability. Although traceability has been a main focus of many laboratory standardization activities in the past, discussions are still ongoing with regard to traceability and its implementation. Content: This review provides information about the traceability concept and what needs can be fulfilled and benefits achieved by the availability of traceable measurement results. Special emphasis is given to the new metrological terminology introduced with this concept. The review addresses and describes approaches for technical implementation of traceable methods as well as the associated challenges. Traceability is also discussed in the context of other activities to improve the overall measurement process. Summary: Establishing metrological traceability of measurement results satisfies basic clinical and public health needs, thus improving patient care and disease control and prevention. Large advances have been made to facilitate the implementation of traceability. However, details in the implementation process, such as lack of available commutable reference materials and insufficient resources to develop new reference measurement systems continue to challenge the laboratory medicine community.

scholarly journals Establishing reference laboratories in laboratory medicine

2005 ◽  
Vol 24 (3) ◽  
pp. 207-214 ◽  
Author(s):  
Lothar Siekmann
Keyword(s):  
Data Base ◽  
Reference Materials ◽  
Measurement Procedure ◽  
Laboratory Medicine ◽  
Calibration Laboratory ◽  
Iso 17025 ◽  
Reference Measurement ◽  
Measurement Traceability ◽  
Test Kit ◽  
Ring Trial

The concept of measurement traceability provides probably the most important strategy to achieve standardization in laboratory medicine aimed at comparable measurement results regardless of the method, the measurement procedure (test kit) and of the laboratory where analyses are carried out. Establishing networks of reference laboratories is - in addition to reference measurement procedures and reference materials - one of the biggest challenges in implementing the concept of measurement traceability. With respect to these requirements, the Joint Committee on Traceability in Laboratory Medicine (JCTLM), established by the BIPM, the IFCC and the ILAC, has launched two projects in its working groups. WG-1 has to date published tables of reference materials and reference procedures on the BIPM web-sites, whereas WG-2 is identifying reference measurement laboratories. There is general agreement now that reference laboratories should be identified - according to the metrological level of the procedures applied where the principle of measurement is the most important criterion, - on the basis of accreditation or at least compliance with ISO 15195 or ISO 17025 as calibration laboratory, and - on the basis of their ability to demonstrate performance in regular inter - laboratory comparisons (ring trials). To date, a data base on candidate reference laboratories has been collected containing information on the laboratory identity, the metrological level of the procedures and on the status of accreditation and the participation in networks or ring trials. The data base currently contains the addresses of about 60 laboratories. On average, each of the laboratories reported measurement capabilities for six different measurands resulting in about 360 entries. The IFCC has recently launched a ring trial program for reference laboratories for some thirty different measurands. Ring trial results not only demonstrate the competence of individual laboratories, but also reveal the equivalence or bias of different reference procedures. .

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