Metrological traceability of calibration in the estimation and use of common medical decision-making criteria

Thienpont, Linda M.; Uytfanghe, Katleen Van; Cabaleiro, Diego Rodríguez

doi:10.1515/cclm.2004.138

Cited by 27 publications

(15 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Nevertheless, it must be stressed that in principle our reference values are valid only for the stated analytical procedures/systems. The transferability of such reference values to other laboratories would imply the absence of any significant between-laboratory analytical bias (27 ), which is a prerequisite for the production and use of common reference intervals (28,29 ).…”

Section: Discussionmentioning

confidence: 99%

The REALAB Project: A New Method for the Formulation of Reference Intervals Based on Current Data

Grossi

Colombo

Cavuto³

et al. 2005

Clinical Chemistry

View full text Add to dashboard Cite

Background:In a primary healthcare center concerned more with maintaining wellness than with diagnosing and monitoring illness, it is particularly important to compare patients' results with reference intervals derived from a matched population by use of defined statistical methods. Methods: Laboratory results over a 3-year period (ϳ15 000 000 records; 197 350 individuals) were retrieved from our laboratory information system. An inclusion/ exclusion procedure for individual patients was applied based on (a) presence of at least 1 of 23 previously defined "basic tests"; (b) only 1 measurement per test by the laboratory over the 3-year period; (c) for each test, absence of any abnormality in the correlated tests. Before the third step, correlations among quantities were assessed by a Spearman correlation matrix, comparing each of the 23 basic tests with all remaining tests by use of a novel multivariate algorithm. Results: The initial sample group (n ‫؍‬ 197 350) was reduced stepwise by the selection criteria outlined above to 166 027, then to 93 649, and finally to 61 246 individuals constituting our reference sample group. Results from the last 2 groups were used to calculate sex-specific, and in some cases age-related, reference limits for the 23 basic tests and for 13 additional quantities. Reference limits were calculated throughout this study by nonparametric estimation of percentiles. Conclusion: Reference values derived by retrospective

show abstract

Section: Discussionmentioning

confidence: 99%

The REALAB Project: A New Method for the Formulation of Reference Intervals Based on Current Data

Grossi

Colombo

Cavuto³

et al. 2005

Clinical Chemistry

View full text Add to dashboard Cite

show abstract

“…In order to harmonize the serum creatinine results and their interpretation the applicability of recommended "common" reference intervals for creatinine concentrations was evaluated [28][29][30] . Serum creatinine concentrations were measured using specific enzymatic method traceable to the IDMS method in comparison to the uncompensated Jaffe kinetic creatinine method [31] .…”

Section: Applicability Of Common Reference Intervals For Serum Creatimentioning

confidence: 99%

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

Flegar-Meštrić¹,

Perkov²,

Radeljak³

2016

WJM

View full text Add to dashboard Cite

provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medi cine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardiza tion and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar sociodemographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. AbstractConsidering the fact that the results of laboratory tests MINIREVIEWS 93March 26, 2016|Volume 6|Issue 1|

show abstract

“…Some years ago, Thienpont et al (37) already pointed out that the absence of clearly defi ned tolerable deviations derived from clinical needs " might results in a large gray zone with respect to the extent of traceability expected from diagnostic manufacturers, partially or totally invalidating its theoretical advantages " . Today, there is a substantial agreement that the uncertainty of measurement that fi ts for purpose must be defi ned across the entire traceability chain, starting with the provider of reference materials, extending through the diagnostic manufacturers and their processes for assignment of calibrator values, and ultimately to the fi nal result reported to clinicians by end users (i.e., the clinical laboratories) (38,39) .…”

Section: Need To Defi Ne the Clinically Acceptable Limits For Validatmentioning

confidence: 99%

Implementation of standardization in clinical practice: not always an easy task

Panteghini

2012

Clinical Chemistry and Laboratory Medicine (CCLM)

View full text Add to dashboard Cite

As soon as a new reference measurement system is adopted, clinical validation of correctly calibrated commercial methods should take place. Tracing back the calibration of routine assays to a reference system can actually modify the relation of analyte results to existing reference intervals and decision limits and this may invalidate some of the clinical decision-making criteria currently used. To maintain the accumulated clinical experience, the quantitative relationship to the previous calibration system should be established and, if necessary, the clinical decision-making criteria should be adjusted accordingly. The implementation of standardization should take place in a concerted action of laboratorians, manufacturers, external quality assessment scheme organizers and clinicians. Dedicated meetings with manufacturers should be organized to discuss the process of assay recalibration and studies should be performed to obtain convincing evidence that the standardization works, improving result comparability. Another important issue relates to the surveillance of the performance of standardized assays through the organization of appropriate analytical internal and external quality controls. Last but not least, uncertainty of measurement that fi ts for this purpose must be defi ned across the entire traceability chain, starting with the available reference materials, extending through the manufacturers and their processes for assignment of calibrator values and ultimately to the fi nal result reported to clinicians by laboratories.

show abstract

Metrological traceability of calibration in the estimation and use of common medical decision-making criteria

Cited by 27 publications

References 17 publications

The REALAB Project: A New Method for the Formulation of Reference Intervals Based on Current Data

The REALAB Project: A New Method for the Formulation of Reference Intervals Based on Current Data

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

Implementation of standardization in clinical practice: not always an easy task

Contact Info

Product

Resources

About