Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures

2019 ◽  
Keyword(s):  
Laboratory Medicine ◽  
Reference Measurement ◽  
Calibration Laboratories

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.

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. .

scholarly journals Implementation of metrological traceability in laboratory medicine: where we are and what is missing

2020 ◽  
Vol 58 (8) ◽  
pp. 1200-1204 ◽  
Author(s):  
Mauro Panteghini ◽  
Federica Braga
Keyword(s):  
Mass Spectrometry ◽  
Measurement System ◽  
Task Force ◽  
Metrological Traceability ◽  
Laboratory Medicine ◽  
Isotopic Dilution ◽  
Clinical Samples ◽  
Reference Measurement ◽  
Reference Measurement System

AbstractBackgroundThe Joint Committee on Traceability in Laboratory Medicine (JCTLM) has recently created the Task Force on Reference Measurement System Implementation (TF-RMSI) for providing guidance on traceability implementation to in vitro diagnostics (IVD) manufacturers. Using serum creatinine (sCr) as an example, a preliminary exercise was carried out by checking what type of information is available in the JCTLM database and comparing this against derived analytical performance specifications (APS) for measurement uncertainty (MU) of sCr.ContentAPS for standard MU of sCr measurements were established as a fraction (≤0.75, minimum quality; ≤0.50, desirable quality; and ≤0.25, optimum quality) of the intra-individual biological variation of the measurand (4.4%). By allowing no more than one third of the total MU budget for patient samples to be derived from higher-order references, two out of the four JCTLM reference materials (RMs) at least allow minimum APS to be achieved for the MU of patient samples. Commutability was explicitly assessed for one of the JCTLM-listed matrixed RMs, which was produced in compliance with ISO 15194:2009 standard, whereas the remaining three RMs were assessed against the ISO 15194:2002 version of the standard, which only required the extent of commutability testing to be reported. Regarding the three listed reference methods, the MU associated with isotopic dilution-mass spectrometry coupled to gas chromatography (ID/GC/MS) and isotopic dilution-mass spectrometry coupled to liquid chromatography (ID/LC/MS) would allow APS to be fulfilled, while the isotope dilution surface-enhanced Raman scattering (ID/SERS) method displays higher MU.SummaryThe most recently listed RM for sCr in the JCTLM database meets the ISO 15194:2009 requirements with MU that would allow APS to be fulfilled and has had commutability demonstrated for use as a common calibrator in implementing traceability of sCr measurements. Splitting clinical samples with a laboratory performing ID/GC/MS or ID/LC/MS provides an alternative but would also require all components of uncertainty of these materials to be assessed.OutlookUsing appropriately derived APS to judge whether reference measurement system components are fit for purpose represents a novel approach. The TF-RMSI is planning to review a greater number of measurands to provide more robust information about the state of the art of available reference measurement systems and their impact on the ability of clinical measurements to meet APS.

scholarly journals Progress and impact of enzyme measurement standardization

2017 ◽  
Vol 55 (3) ◽  
Author(s):  
Ilenia Infusino ◽  
Erika Frusciante ◽  
Federica Braga ◽  
Mauro Panteghini
Keyword(s):  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Substantial Improvement ◽  
International Federation ◽  
Clinical Samples ◽  
Reference Measurement ◽  
Evaluation Approach ◽  
Clinical Enzymology ◽  
Phosphate Addition

AbstractInternational Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has established reference measurement procedures (RMPs) for the most popular enzymes. Manufacturers should assign values to commercial calibrators traceable to these RMPs to achieve equivalent results in clinical samples, independent of reagent kits, instruments, and laboratory where the measurement is carried out. The situation is, however, far from acceptable. Some manufacturers continue to market assays giving results that are not traceable to internationally accepted RMPs. Meanwhile, end-users often do not abandon assays with demonstrated insufficient quality. Of the enzyme measurements, creatine kinase (CK) is satisfactorily standardized and a substantial improvement in performance of marketed γ-glutamyltranspeptidase (GGT) assays has been demonstrated. Conversely, aminotransferase measurements often exceed the desirable analytical performance because of the lack of pyridoxal-5-phosphate addition in the commercial reagents. Measurements of lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and α-amylase (AMY) still show major disagreement, suggesting the need for improvement in implementing traceability to higher-order references. This is mainly the result of using assays with different analytical selectivities for these enzymes. The definition by laboratory professionals of the clinically acceptable measurement uncertainty for each enzyme together with the adoption by EQAS of commutable materials and use of an evaluation approach based on trueness represent the way forward for reaching standardization in clinical enzymology.

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