Harmonization status of procalcitonin measurements: what do comparison studies and EQA schemes tell us?

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Huu-Hien, Huynh
Boeuf, Amandine
Pfannkuche, Jens
Schuetz, Philipp
Thelen, Marc
Nordin, Gunnar
van der Hagen, Eline
Kaiser, Patricia
Kesseler, Dagmar
Badrick, Tony
Poggi, Bernard
Tiikkainen, Ulla
Davies, Gareth J
Kessler, Anja
Plebani, Mario
et al.
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2021
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Abstract

Sepsis represents a global health priority because of its high mortality and morbidity. The key to improving prognosis remains an early diagnosis to initiate appropriate antibiotic treatment. Procalcitonin (PCT) is a recognized biomarker for the early indication of bacterial infections and a valuable tool to guide and individualize antibiotic treatment. To meet the increasing demand for PCT testing, numerous PCT immunoassays have been developed and commercialized, but results have been questioned. Many comparison studies have been carried out to evaluate analytical performance and comparability of results provided by the different commercially available immunoassays for PCT, but results are conflicting. External Quality Assessment Schemes (EQAS) for PCT constitute another way to evaluate results comparability. However, when making this comparison, it must be taken into account that the variety of EQA materials consist of different matrices, the commutability of which has not yet been investigated. The present study gathers results from all published comparison studies and results from 137 EQAS surveys to describe the current state-of-the-art harmonization of PCT results. Comparison studies globally highlight a significant variability of measurement results that nonetheless seem to have a moderate impact on medical decision-making. For their part, EQAS for PCT provides highly discrepant estimates of the interlaboratory CV. Due to differences in commutability of the EQA materials, the results from different peer groups could not be compared. To improve the informative value of the EQA data, the existing limitations such as non-harmonized conditions and suboptimal and/or unknown commutability of the EQA materials have to be overcome. The study highlights the need for commutable reference materials that could be used to properly evaluate result comparability and possibly standardize calibration, if necessary. Such an initiative would further improve the safe use of PCT in clinical routine.

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Clinical Chemistry and Laboratory Medicine

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59

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10

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© 2021 Walter de Gruyter & Co. KG Publishers. The attached file is reproduced here in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version.

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Clinical sciences

Cognitive and computational psychology

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Life Sciences & Biomedicine

Medical Laboratory Technology

equivalence

external-quality-assessment

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Huu-Hien, H; Boeuf, A; Pfannkuche, J; Schuetz, P; Thelen, M; Nordin, G; van der Hagen, E; Kaiser, P; Kesseler, D; Badrick, T; Poggi, B; Tiikkainen, U; Davies, GJ; Kessler, A; Plebani, M; Vinh, J; Delatour, V, Harmonization status of procalcitonin measurements: what do comparison studies and EQA schemes tell us?, Clinical Chemistry and Laboratory Medicine, 2021, 59 (10), pp. 1610-1622

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