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  1. Article ; Online: Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability.

    Panteghini, Mauro

    Clinical chemistry and laboratory medicine

    2024  

    Abstract: In addition to the correct implementation of calibration traceability, the definition and fulfillment of maximum allowable measurement uncertainty (MAU) are essential in assuring that laboratory measurements are clinically usable. Across the entire ... ...

    Abstract In addition to the correct implementation of calibration traceability, the definition and fulfillment of maximum allowable measurement uncertainty (MAU) are essential in assuring that laboratory measurements are clinically usable. Across the entire calibration hierarchy, three major contributors to the measurement uncertainty (MU) budget are identified, starting with the higher-order reference providers, extending through the
    Language English
    Publishing date 2024-02-05
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2023-1325
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: What the Milan conference has taught us about analytical performance specification model definition and measurand allocation.

    Panteghini, Mauro

    Clinical chemistry and laboratory medicine

    2024  

    Abstract: Analytical performance specifications (APS) represent the criteria that specify the quality required for laboratory test information to satisfy clinical needs. In 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) ... ...

    Abstract Analytical performance specifications (APS) represent the criteria that specify the quality required for laboratory test information to satisfy clinical needs. In 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) considered timely to update the topic of APS by organizing a conference in Milan in which some strategic concepts were proposed. Here I summarize the essential points representing the EFLM Strategic Conference heritage and discuss the approaches that will permit us to become more concrete, including roles and main actions expected from each of involved stakeholders for contributing a quantum leap forward in the way of practicality of Milan consensus about APS.
    Language English
    Publishing date 2024-01-25
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2023-1257
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Evaluating and monitoring analytical quality by internal quality control.

    Panteghini, Mauro

    Clinical biochemistry

    2023  Volume 118, Page(s) 110594

    MeSH term(s) Humans ; Quality Control ; Reference Standards ; Uncertainty ; Calibration
    Language English
    Publishing date 2023-06-02
    Publishing country United States
    Document type Letter
    ZDB-ID 390372-2
    ISSN 1873-2933 ; 0009-9120
    ISSN (online) 1873-2933
    ISSN 0009-9120
    DOI 10.1016/j.clinbiochem.2023.110594
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: A Comment about Analytical Performance Specifications for the Combined Measurement Uncertainty Budget in the Implementation of Metrological Traceability of Parathyroid Hormone.

    Panteghini, Mauro

    Clinical chemistry

    2023  Volume 70, Issue 2, Page(s) 456–457

    MeSH term(s) Humans ; Uncertainty ; Parathyroid Hormone ; Reference Standards ; Quality Control
    Chemical Substances Parathyroid Hormone
    Language English
    Publishing date 2023-11-30
    Publishing country England
    Document type Editorial ; Comment
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvad192
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Developments in reference measurement systems for C-reactive protein and the importance of maintaining currently used clinical decision-making criteria.

    Panteghini, Mauro

    Clinical chemistry and laboratory medicine

    2023  Volume 61, Issue 9, Page(s) 1537–1539

    MeSH term(s) Humans ; C-Reactive Protein ; Reference Standards ; Quality Control ; Clinical Decision-Making ; Calibration
    Chemical Substances C-Reactive Protein (9007-41-4)
    Language English
    Publishing date 2023-06-05
    Publishing country Germany
    Document type Editorial
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2023-0558
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Documenting and validating metrological traceability of serum alanine aminotransferase measurements: a priority for medical laboratory community for providing high quality service in hepatology.

    Panteghini, Mauro

    Clinical chemistry and laboratory medicine

    2023  Volume 62, Issue 2, Page(s) 249–252

    Abstract: Alanine aminotransferase (ALT) represents the first-level test to detect individuals with hepatocellular damage of any etiology. However, it has been highlighted that the lack of assay harmonization may lead to overdiagnosis and unnecessary further ... ...

    Abstract Alanine aminotransferase (ALT) represents the first-level test to detect individuals with hepatocellular damage of any etiology. However, it has been highlighted that the lack of assay harmonization may lead to overdiagnosis and unnecessary further testing if guideline-recommended fixed cut-offs are uncritically employed. To solve the issue of ALT (dis)harmonization and improve the interpretation of its values, a series of urgent actions for documenting and validating metrological traceability of serum ALT measurements, as described in this paper, are no longer postponeable. It is time that all medical laboratory stakeholders (
    MeSH term(s) Humans ; Clinical Laboratory Techniques ; Alanine Transaminase ; Gastroenterology ; Reference Standards
    Chemical Substances Alanine Transaminase (EC 2.6.1.2)
    Language English
    Publishing date 2023-09-13
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2023-0900
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: The simple reproducibility of a measurement result does not equal its overall measurement uncertainty.

    Panteghini, Mauro

    Clinical chemistry and laboratory medicine

    2022  Volume 60, Issue 10, Page(s) e221–e222

    MeSH term(s) Calibration ; Humans ; Reference Standards ; Reproducibility of Results ; Uncertainty
    Language English
    Publishing date 2022-07-11
    Publishing country Germany
    Document type Letter ; Comment
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2022-0618
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Reply to Westgard et al.: 'Keep your eyes wide … as the present now will later be past'.

    Panteghini, Mauro

    Clinical chemistry and laboratory medicine

    2022  Volume 60, Issue 9, Page(s) e202–e203

    MeSH term(s) Eye ; Humans ; Laboratories ; Quality Control
    Language English
    Publishing date 2022-07-04
    Publishing country Germany
    Document type Letter ; Comment
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2022-0557
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  9. Article ; Online: Laboratory Community Should Be More Proactive in Highlighting the Negative Impact of Analytical Non-Selectivity of Some Creatinine Assays.

    Panteghini, Mauro

    Clinical chemistry

    2022  Volume 68, Issue 5, Page(s) 723

    MeSH term(s) Biological Assay ; Creatinine ; Glomerular Filtration Rate ; Humans ; Laboratories
    Chemical Substances Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2022-03-06
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvac031
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Redesigning the surveillance of

    Panteghini, Mauro

    Clinical chemistry and laboratory medicine

    2022  Volume 61, Issue 5, Page(s) 759–768

    Abstract: IVD manufacturers have total responsibility in terms of the traceability of ... ...

    Abstract IVD manufacturers have total responsibility in terms of the traceability of marketed
    MeSH term(s) Humans ; Reference Standards ; Reagent Kits, Diagnostic ; Quality Control ; Uncertainty ; Reproducibility of Results ; Laboratories
    Chemical Substances Reagent Kits, Diagnostic
    Language English
    Publishing date 2022-12-22
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2022-1257
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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