Journal
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
Volume 59, Issue 10, Pages 1610-1622Publisher
WALTER DE GRUYTER GMBH
DOI: 10.1515/cclm-2021-0566
Keywords
equivalence; external-quality-assessment; harmonization; method comparison; procalcitonin; sepsis
Categories
Funding
- European Metrology Programme for Innovation and Research (EMPIR) [15HLT07, 18HLT03]
- European Union
- CIFRE scholarship by ANRT (Association Nationale de la Recherche et de la Technologie) [2017/1011]
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Sepsis is a global health concern due to its high mortality and morbidity rates, and early diagnosis with the use of biomarkers like procalcitonin (PCT) is crucial for improving prognosis. However, the comparability of results from different commercially available PCT immunoassays has raised concerns, highlighting the need for commutable reference materials to enhance result comparability. This would ultimately improve the safe use of PCT in clinical settings.
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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