Calcium, Magnesium, Albumin, and Total Protein Measurement in Serum as Assessed with 20 Fresh-Frozen Single-Donation Sera

Houcke, Sofie K. Van; Rustad, Pål; Stepman, Hedwig; Kristensen, Gunn B.B.; Stöckl, Dietmar; Røraas, Thomas; Sandberg, Sverre; Thienpont, Linda M.

doi:10.1373/clinchem.2012.189670

Cited by 21 publications

(15 citation statements)

References 3 publications

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“…For many analytes, our findings were comparable, e.g. glucose and cholesterol met, quality criteria whereas HDL cholesterol (Abbott) did not [8], neither did calcium and total protein meet the criteria [6]. We found that alkaline phosphatase (AP), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), and lactate dehydrogenase (LD) were not traceable to the respective IFCC RMPs.…”

Section: Comparison With Similar Eqa Conceptsmentioning

confidence: 62%

“…There are only a few EQA schemes using commutable samples, most of them related to the group of Thienpont et al [6][7][8][9]. It is worth considering the differences between our two approaches in terms of the findings of our schemes and the use of slightly different samples.…”

Section: Comparison With Similar Eqa Conceptsmentioning

confidence: 99%

“…Standardization and harmonization efforts minimize differences between laboratories and are the core issues of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the American Association of Clinical Chemistry (AACC) [4,5]. External quality assessment (EQA)/proficiency test (PT) organizers play an important role in monitoring the performance of individual laboratories, but also in supplying information on the progress of standardization/harmonization efforts [6][7][8][9]. In a recent review, EQA/PT schemes are categorized on basis of three characteristics: (a) commutability of the samples, (b) value assignment of targets (with a RMP or not), and (c) inclusion of replicate samples (yes or no) [10].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain

Weykamp

Secchiero

Plebani

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background: Optimum patient care in relation to laboratory medicine is achieved when results of laboratory tests are equivalent, irrespective of the analytical platform used or the country where the laboratory is located. Standardization and harmonization minimize differences and the success of efforts to achieve this can be monitored with international category 1 external quality assessment (EQA) programs.

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Section: Comparison With Similar Eqa Conceptsmentioning

confidence: 62%

Section: Comparison With Similar Eqa Conceptsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain

Weykamp

Secchiero

Plebani

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…The focus of the master comparisons, which are conducted across assays and laboratories, is on how well the intrinsic analytical quality of assays released by the respective manufacturers is reproduced by the end users under "field" conditions all over the world. Results about master comparison with a panel of 20 frozen single donation samples for calcium, magnesium, albumin, total protein [16,17], sodium [18], creatinine, glucose, phosphate, uric acid, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides [19], have been previously described. In a recent survey AST, ALT, LDH, GGT and ALP, sodium, potassium and chloride have been added.…”

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confidence: 99%

A new integrated tool for assessing and monitoring test comparability and stability

Secchiero¹,

Plebani²

2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Performing accurate measurements, comparable over time and location and across assays, is essential to ensure appropriate clinical practice [1]. One step towards achieving this goal is using assays that are metrologically traceable to a higher order reference measurement system or harmonized using internationally recognized procedures [2,3]. In Europe, diagnostic manufacturers are required by the European Union Directive on in vitro diagnostic medical devices to demonstrate the metrological traceability of their analytical systems [4]. Thus, in principle, laboratories using CE-marked homogeneous systems (calibrator, reagent and instrument from the same manufacturer) can assume accuracy and interchangeability of their measurements results. However, it is the task of clinical laboratory profession to verify that the alignment process has been correctly implemented and that the performances of marketed systems are really appropriate for their clinical use. In particular, the laboratory has to verify the consistency of the manufacturer's declared performance during routine operations performed strictly in accordance with their instruction, and to participate in external quality assessment (EQA)/proficiency testing (PT) schemes structured so that they provide objective information on the analytical quality of measurements performed by clinical laboratories and on the performances of the peer group assays [5][6][7]. EQA programs using commutable materials and reference method target values are becoming more widespread, but until now they are applied only to few constituents (i.e., hemoglobin A 1c ) [8,9]. Generally, an EQA program for clinical biochemistry on serum, performed by an independent national or regional center, with a sufficient number of participants so that the peer groups can be well defined, consists in a panel of about 25-35 measurands. Even if controls materials are made ad hoc, namely to evaluate clinically important concentrations, the commutability for all measurands and diagnostic systems is difficult to be achieved. Moreover, being target values by reference methods available for a few measurands and extremely expensive, it is very difficult to get a reference target values for all measurands. Finally, just for the intrinsic design of an EQA program, the data are not available in real time. In this issue of Clinical Chemistry and Laboratory Medicine, the team of Thienpont and colleagues, whose remarkable dedication to the improvement of quality, standardization and harmonization of clinical laboratory testing is well appreciated at an international level and by the readers of the journal [10][11][12][13][14], describes a new project aimed to establish a bottom-up cooperation between laboratories and manufacturers, so that they can pursue the common objective of assessing test comparability and stability of laboratory results [15]. The "Empower" project, proposed as an independently operated "online" tool that should monitor comparability and long-term stability between peer groups and laboratorie...

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“…In this issue of Clinical Chemistry, Stepman et al (8 ) meaningfully extend a novel approach some of them had previously reported (9 ). They collected 20 single-donor sera according to CLSI protocol 37-A, from which they made 1-mL aliquots, which were frozen at Ϫ70°C until analysis.…”

mentioning

confidence: 99%

Assessing Accuracy on the Front Lines: A Pragmatic Approach for Single-Donor Proficiency Testing

Horowitz

2014

Clinical Chemistry

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Calcium, Magnesium, Albumin, and Total Protein Measurement in Serum as Assessed with 20 Fresh-Frozen Single-Donation Sera

Cited by 21 publications

References 3 publications

Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain

Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain

A new integrated tool for assessing and monitoring test comparability and stability

Assessing Accuracy on the Front Lines: A Pragmatic Approach for Single-Donor Proficiency Testing

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