Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences

Fuentes-Arderiu, Xavier; Mas-Serra, Roser; Alumà-Trullàs, Alba; Martí-Marcet, Maria Isabel; Dot-Bach, Dolors

doi:10.1515/cclm.2004.130

Cited by 20 publications

(9 citation statements)

References 10 publications

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“…This way of thinking seems too conceptual for clinicians; for him/her, the cut-off value (decision limit) alone will be taken into account. 6. We are quite far away from the recommendation of the IFCC (95% reference intervals).…”

Section: The Concept Of Reference Values Is Not Used By Laboratory Scmentioning

confidence: 90%

“…There are, however, strong arguments in favor of such a publication. In this issue, Fuentes-Arderiu et al suggest techniques for determining multicenter reference values (6). Some laboratory scientists are publishing interesting scientific papers without following the official recommendation of Scientific Bodies using the desirable rigor.…”

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confidence: 99%

“…The knowledge of relevant biological variability. In this type of event, statistical tools are largely developed and used; some of which are presented in this issue (6,7,15). As pointed out by Claude Petitclerc, the definition of normality in laboratory medicine is challenging due to the virtual impossibility of selecting an unbiased healthy population (13).…”

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confidence: 99%

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Reference values: from philosophy to a tool for laboratory medicine

Henny¹,

Petersen²

2004

Clinical Chemistry and Laboratory Medicine (CCLM)

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Section: The Concept Of Reference Values Is Not Used By Laboratory Scmentioning

confidence: 90%

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confidence: 99%

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Reference values: from philosophy to a tool for laboratory medicine

Henny¹,

Petersen²

2004

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Bearing in mind all of the above, the aims of this work were (i) to establish physiological reference limits for the concentration of creatininium in plasma using a multicentre approach (8), and (ii) to evaluate the specificity of the glomerular filtration rate estimated with the four-variable MDRD Study equation when applied to healthy persons to screen for chronic kidney disease.…”

Section: Introductionmentioning

confidence: 99%

Multicentre physiological reference values for the concentration of creatininium in plasma and diagnostic specificity of glomerular filtration rate estimated with the MDRD equation

Fuentes-Arderiu

Álvarez-Funes²,

Coca-Fábregas³

et al. 2007

Clinical Chemical Laboratory Medicine

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“…The production of common RIs for homogeneous populations shared by all laboratories within a country or a region has attracted a lot of interest. In Spain, the Catalan Association for Clinical Laboratory Science has demonstrated that it is possible to establish common RIs for an entire country for laboratories using the same equipment and reagents, with ensured metrological traceability [ 5 ]. Almost simultaneously, a Nordic European Group proposed a new concept of shared reference values based on the recommendations of the IFCC-LM, but specifying prerequisites [ 6 ].…”

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confidence: 99%

Multicenter reference intervals studies: a promising perspective for the future?

Henny

2013

Clinical Chemistry and Laboratory Medicine

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Up to now the establishment of reference limits has been based on the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC-LM) which give greater place to determining reference intervals (RIs) in each laboratory [ 1 ]. In fact, the situation is complex: regulations (e.g., European Directive 98/79/EC [ 2 ] and the new revised version pending approval) require that manufacturers mention RIs in the package inserts (for all countries). Clinical laboratories are responsible for RIs printed on laboratory reports (ISO 15189) [ 3 ]. Laboratories should also verify them if they use RIs from literature or manufacturers. Also, producing RIs is actually too expensive and a heavy task for most laboratories. Alternatives have been proposed, such as the determination of RIs from databases from each laboratory (data mining) [ 4 ], but relevant clinical information, needed to select healthy individuals, is rarely available. That is why the IFCC/ CLSI remains reserved on this method. The production of common RIs for homogeneous populations shared by all laboratories within a country or a region has attracted a lot of interest. In Spain, the Catalan Association for Clinical Laboratory Science has demonstrated that it is possible to establish common RIs for an entire country for laboratories using the same equipment and reagents, with ensured metrological traceability [ 5 ]. Almost simultaneously, a Nordic European Group proposed a new concept of shared reference values based on the recommendations of the IFCC-LM, but specifying prerequisites [ 6 ]. This protocol is based on the need for a common standardization and traceability throughout the production phase of the reference values. A process of external quality control using commutable materials (no matrix effect) and traceable to the same reference method is implemented. The analytical specifications will be defined beforehand. These authors point out that there are no recommendations for the selection of reference individuals, these being dependant on the study objectives. However, if the subgroups are large enough ( > 500) the partitioning criteria can be applied and the confidence limits for RIs will be small. This protocol applied to a group of laboratories in several Scandinavian countries has shown its effectiveness. On behalf of the IFCC-LM, Ceriotti [ 7 , 8 ] completed these prerequisites to determine common RIs: 1) the population that the laboratory services is similar to the one studied; 2) careful study design; 3) use of traceable analytical methods; 4) predefined analytical goals; 5) adequate statistical treatment.In this issue, Ichihara et al. present two very ambitious articles [ 9 , 10 ] attempting to provide answers to many questions: 1) observe possible differences between the populations studied in seven regions of East and SouthEast Asia and in seven regions of Japan; 2) assess the possible need for partitioning RIs; 3) derive common RIs for standardized analytes (traceable to a reference method); 4) propose a ...

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Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences

Cited by 20 publications

References 10 publications

Reference values: from philosophy to a tool for laboratory medicine

Reference values: from philosophy to a tool for laboratory medicine

Multicentre physiological reference values for the concentration of creatininium in plasma and diagnostic specificity of glomerular filtration rate estimated with the MDRD equation

Multicenter reference intervals studies: a promising perspective for the future?

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