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Article ; Online: Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models.

Braga, Federica / Panteghini, Mauro

Clinical chemistry and laboratory medicine

2021

Abstract: Objectives: Definition and fullfillment of analytical performance specifications (APS) for measurement uncertainty (MU) allow to make laboratory determinations clinically usable. The 2014 Milan Strategic Conference have proposed models to objectively ... ...

Abstract	Objectives: Definition and fullfillment of analytical performance specifications (APS) for measurement uncertainty (MU) allow to make laboratory determinations clinically usable. The 2014 Milan Strategic Conference have proposed models to objectively derive APS based on: (a) the effect of analytical performance on clinical outcome; (b) biological variation components; and (3) the state of the art of the measurement, defined as the highest level of analytical performance technically achievable. Using these models appropriately, we present here a proposal for defining APS for standard MU for some common biochemical measurands. Methods: We allocated a group of 13 measurands selected among the most commonly laboratory requested tests to each of the three Milan models on the basis of their biological and clinical characteristics. Both minimum and desirable levels of quality of APS for standard MU of clinical samples were defined by using information obtained from available studies. Results: Blood total hemoglobin, plasma glucose, blood glycated hemoglobin, and serum 25-hydroxyvitamin D3 were allocated to the model 1 and the corresponding desirable APS were 2.80, 2.00, 3.00, and 10.0%, respectively. Plasma potassium, sodium, chloride, total calcium, alanine aminotransferase, creatinine, urea, and total bilirubin were allocated to the model 2 and the corresponding desirable APS were 1.96, 0.27, 0.49, 0.91, 4.65, 2.20, 7.05, and 10.5%, respectively. For C-reactive protein, allocated to the model 3, a desirable MU of 3.76% was defined. Conclusions: APS for MU of clinical samples derived in this study are essential to objectively evaluate the reliability of results provided by medical laboratories.
Language	English
Publishing date	2021-03-16
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-2021-0170
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Article ; Online: Biological variation of serum cholinesterase catalytic concentrations.

Altilia, Mariangela / Braga, Federica / Capoferri, Alessia / Panteghini, Mauro

Clinical chemistry and laboratory medicine

2022 Volume 60, Issue 8, Page(s) e177–e180

MeSH term(s)	Cholinesterases ; Humans
Chemical Substances	Cholinesterases (EC 3.1.1.8)
Language	English
Publishing date	2022-05-16
Publishing country	Germany
Document type	Letter
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2022-0346
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Article ; Online: Derivation of performance specifications for uncertainty of serum C-reactive protein measurement according to the Milan model 3 (state of the art).

Braga, Federica / Panteghini, Mauro

Clinical chemistry and laboratory medicine

2020 Volume 58, Issue 11, Page(s) e263–e265

MeSH term(s)	Blood Chemical Analysis/standards ; C-Reactive Protein/analysis ; C-Reactive Protein/standards ; Calibration ; Humans ; Models, Chemical ; Reference Standards ; Uncertainty
Chemical Substances	C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2020-06-29
Publishing country	Germany
Document type	Letter
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2020-0532
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Article ; Online: The utility of measurement uncertainty in medical laboratories.

Braga, Federica / Panteghini, Mauro

Clinical chemistry and laboratory medicine

2020 Volume 58, Issue 9, Page(s) 1407–1413

Abstract: The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference) methods and/or materials, together with a clinically acceptable level of measurement ... ...

Abstract	The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference) methods and/or materials, together with a clinically acceptable level of measurement uncertainty (MU), are fundamental requirements to produce accurate and equivalent laboratory results. The MU associated with each step of the traceability chain should be governed to obtain a final combined MU on clinical samples fulfilling the requested performance specifications. MU is useful for a number of reasons: (a) for giving objective information about the quality of individual laboratory performance; (b) for serving as a management tool for the medical laboratory and in vitro diagnostics (IVD) manufacturers, forcing them to investigate and eventually fix the identified problems; (c) for helping those manufacturers that produce superior products and measuring systems to demonstrate the superiority of those products; (d) for identifying analytes that need analytical improvement for their clinical use and ask IVD manufacturers to work for improving the quality of assay performance and (e) for abandoning assays with demonstrated insufficient quality. Accordingly, the MU should not be considered a parameter to be calculated by medical laboratories just to fulfill accreditation standards, but it must become a key quality indicator to describe both the performance of an IVD measuring system and the laboratory itself.
MeSH term(s)	Biological Assay/standards ; Humans ; Laboratories/standards ; Quality Control ; Reference Standards ; Uncertainty
Language	English
Publishing date	2020-03-03
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-2019-1336
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Article ; Online: Implementation of metrological traceability in laboratory medicine: where we are and what is missing.

Panteghini, Mauro / Braga, Federica

Clinical chemistry and laboratory medicine

2020 Volume 58, Issue 8, Page(s) 1200–1204

Abstract: Background The 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) ...

Abstract	Background The 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. Content APS 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. Summary The 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. Outlook Using 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.
MeSH term(s)	Calibration ; Chromatography, Liquid ; Clinical Laboratory Information Systems ; Gas Chromatography-Mass Spectrometry ; Humans ; Laboratories/organization & administration ; Laboratories/standards ; Quality Control ; Reproducibility of Results ; Uncertainty
Language	English
Publishing date	2020-02-15
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-2019-1128
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Article ; Online: Harmonization Status of Serum Ferritin Measurements and Implications for Use as Marker of Iron-Related Disorders.

Braga, Federica / Pasqualetti, Sara / Frusciante, Erika / Borrillo, Francesca / Chibireva, Mariia / Panteghini, Mauro

Clinical chemistry

2023 Volume 68, Issue 9, Page(s) 1202–1210

Abstract: Background: Serum ferritin is considered a suitable biomarker of iron-related disorders. However, data about the comparability of results among commercial measuring systems (MSs) are contradictory. We performed an intercomparison study aimed at ... ...

Abstract	Background: Serum ferritin is considered a suitable biomarker of iron-related disorders. However, data about the comparability of results among commercial measuring systems (MSs) are contradictory. We performed an intercomparison study aimed at verifying the current interassay variability and its impact on clinical application of the test. Obtaining this information is vital because manufacturers continue to claim calibration alignment to different WHO preparations, which are not related to each other in terms of traceability. Methods: Four widely used MSs were evaluated. The interassay agreement was verified using 39 human serum pools. The recovery of WHO International Standard (IS) 94/572 (the only reference material available at the time of the study) was evaluated, after assessing the material commutability. Finally, an approach for harmonizing ferritin results was proposed. Results: Highly significant differences (P < 0.00001) among ferritin concentrations assayed by different MSs were detected and the interassay CV (median 22.9%; interquartile range 21.8-25.5) overlapped the desirable intermethod bias (24.6%). IS 94/572 was commutable for use only with Access and Centaur, with Access being the only MS correctly recovering its assigned value. Accordingly, we used regression data against Access to recalibrate MSs, indirectly aligning them to IS 94/572, with a substantial improvement in degree of harmonization and traceability to higher-order reference. Conclusions: The harmonization among evaluated ferritin MSs is far from optimal, with the implementation of traceability to different WHO ISs being a factor of confusion. A recalibration approach, however, would permit measurement harmonization, allowing the use of common decision thresholds.
MeSH term(s)	Biomarkers ; Calibration ; Ferritins ; Humans ; Iron ; Reference Standards
Chemical Substances	Biomarkers ; Ferritins (9007-73-2) ; Iron (E1UOL152H7)
Language	English
Publishing date	2023-11-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvac099
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Article ; Online: Prognostic role of Krebs von den Lungen-6 (KL-6) measurement in idiopathic pulmonary fibrosis: a systematic review and meta-analysis.

Aloisio, Elena / Braga, Federica / Puricelli, Chiara / Panteghini, Mauro

Clinical chemistry and laboratory medicine

2021 Volume 59, Issue 8, Page(s) 1400–1408

Abstract: Objectives: Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial disease with limited therapeutic options. The measurement of Krebs von den Lungen-6 (KL-6) glycoprotein has been proposed for evaluating the risk of IPF progression and ... ...

Abstract	Objectives: Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial disease with limited therapeutic options. The measurement of Krebs von den Lungen-6 (KL-6) glycoprotein has been proposed for evaluating the risk of IPF progression and predicting patient prognosis, but the robustness of available evidence is unclear. Methods: We searched Medline and Embase databases for peer-reviewed literature from inception to April 2020. Original articles investigating KL-6 as prognostic marker for IPF were retrieved. Considered outcomes were the risk of developing acute exacerbation (AE) and patient survival. Meta-analysis of selected studies was conducted, and quantitative data were uniformed as odds ratio (OR) or hazard ratio (HR) estimates, with corresponding 95% confidence intervals (CI). Results: Twenty-six studies were included in the systematic review and 14 were finally meta-analysed. For AE development, the pooled OR (seven studies) for KL-6 was 2.72 (CI 1.22-6.06; p=0.015). However, a high degree of heterogeneity (I Conclusions: Although our meta-analysis suggested that IPF patients with increased KL-6 concentrations had a significant increased risk of developing AE, the detection power of the evaluated biomarker is limited. Furthermore, no relationship between biomarker concentrations and mortality was found. Caution is also needed when extending obtained results to non-Asian populations.
MeSH term(s)	Biomarkers ; Humans ; Idiopathic Pulmonary Fibrosis/diagnosis ; Mucin-1 ; Odds Ratio ; Prognosis ; Proportional Hazards Models
Chemical Substances	Biomarkers ; Mucin-1
Language	English
Publishing date	2021-04-09
Publishing country	Germany
Document type	Journal Article ; Meta-Analysis ; Systematic 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-2021-0199
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Article ; Online: Commutability of reference and control materials: an essential factor for assuring the quality of measurements in Laboratory Medicine.

Braga, Federica / Panteghini, Mauro

Clinical chemistry and laboratory medicine

2019 Volume 57, Issue 7, Page(s) 967–973

Abstract: Traceability to a common reference ensures equivalence of results obtained by different assays. Traceability is achieved by an unbroken sequence of calibrations, using reference materials (RMs) that must be commutable. Using non-commutable RMs for ... ...

Abstract	Traceability to a common reference ensures equivalence of results obtained by different assays. Traceability is achieved by an unbroken sequence of calibrations, using reference materials (RMs) that must be commutable. Using non-commutable RMs for calibration will introduce a bias in the calibrated method producing incorrect results for clinical samples (CS). Commutability was defined in 1973 as "the ability of an enzyme material to show inter-assay activity changes comparable to those of the same enzyme in human serum" and later extended as a characteristic of all RMs. However, the concept is still poorly understood and appreciated. Commutability assessment has been covered in CLSI guidelines and requires: (a) selection of 20 CS spanning the relevant concentration range; (b) analysis of both RM and CS with the pair of procedures; (c) data elaboration using regression analysis and calculation if RM fall within the 95% prediction interval defined by CS. This approach has been criticized and to improve it The International Federation of Clinical Chemistry and Laboratory Medicine established a working group that recently finalized recommendations. Commutability is also a requirement for the applicability of external quality assessment (EQA) results in the evaluation of the performance of participating laboratories in terms of standardization of their measurements. Unfortunately, EQA materials are usually not validated for commutability.
MeSH term(s)	Calibration ; Clinical Laboratory Techniques/standards ; Humans ; Quality Control ; Reference Standards
Language	English
Publishing date	2019-03-18
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-2019-0154
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Article ; Online: Defining permissible limits for the combined uncertainty budget in the implementation of metrological traceability.

Braga, Federica / Panteghini, Mauro

Clinical biochemistry

2018 Volume 57, Page(s) 7–11

Abstract: In addition to the correct implementation of calibration traceability, the definition and the achievement of an appropriate analytical performance specification for the total uncertainty budget ( ... ...

Abstract	In addition to the correct implementation of calibration traceability, the definition and the achievement of an appropriate analytical performance specification for the total uncertainty budget (G
MeSH term(s)	Blood Glucose/analysis ; Calibration ; Clinical Laboratory Techniques/standards ; Creatinine/blood ; Humans ; Reference Standards ; Reproducibility of Results ; Serum Albumin/analysis ; Uncertainty
Chemical Substances	Blood Glucose ; Serum Albumin ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2018-03-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	1873-2933 ; 0009-9120
ISSN (online)	1873-2933
ISSN	0009-9120
DOI	10.1016/j.clinbiochem.2018.03.007
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Article ; Online: The internal quality control in the traceability era.

Braga, Federica / Pasqualetti, Sara / Aloisio, Elena / Panteghini, Mauro

Clinical chemistry and laboratory medicine

2020 Volume 59, Issue 2, Page(s) 291–300

Abstract: To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty (MU) as defined to fit the intended clinical use. With this aim, in vitro ... ...

Abstract	To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty (MU) as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators. Medical laboratories should know and verify how manufacturers have implemented the traceability of their calibrators and estimate the corresponding MU on clinical samples. Accordingly, the internal quality control (IQC) program should be redesigned to permit IVD traceability surveillance through the verification by medical laboratories that control materials, provided by the manufacturer as a part of measuring systems, are in the clinically suitable validation range (IQC component I). Separately, laboratories should also monitor the reliability of employed IVD measuring systems through the IQC component II, devoted to estimation of MU due to random effects and to obtaining MU of provided results, in order to apply prompt corrective actions if the performance is worsening when compared to appropriate analytical specifications, thus jeopardizing the clinical validity of test results.
Language	English
Publishing date	2020-04-28
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-2020-0371
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