Impact of COVID‐19 pandemic on the quality of test output in haemostasis laboratories

Arisz, R. A.; Meijer, Piet; Péquériaux, Nathalie C. V.; Leur, Sjef J van de; Lukens, Michaël V.; Maat, Moniek P.M. de; Hollestelle, Martine J.

doi:10.1111/ijlh.13760

Cited by 3 publications

(1 citation statement)

References 27 publications

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“…From the recent citations, Arisz and colleagues evaluated the quality of test output in hemostasis laboratories due to COVID-19, which had caused a surge in testing, inclusive of D-dimer testing. 12 They conducted a questionnaire that identified that many laboratories reported a large increase of >25% in the number of test requests for anti-Xa, D-dimer, and fibrinogen assays in 2020 compared with 2019. Despite this testing increase, no differences in response rate or the quality of the measurements were observed between EQA surveys from 2019 to 2020.…”

Section: Discussionmentioning

confidence: 99%

Variable Performance of D-dimer Testing by Hemostasis Laboratories: The Australasian/Asia-Pacific Experience

Favaloro,

Arunachalam,

Dean

2024

Semin Thromb Hemost

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D-dimers represent the breakdown products of fibrin. Thus, elevated plasma D-dimers will arise following a thrombotic event, such as a deep vein thrombosis or a pulmonary embolism, and therefore, a nonelevated D-dimer is used to effectively exclude such events. D-dimers are also elevated in a range of other conditions, for example, during disseminated intravascular coagulation. D-dimer levels may also be associated with prognostic value. For example, highly raised D-dimer levels can be associated with worsening clinical features in coronavirus disease 2019. Thus, D-dimer testing represents a commonly requested hemostasis test, often performed in 24/7 laboratories. Unfortunately, D-dimer testing is neither standardized nor harmonized across manufacturers or laboratories. Indeed, considering reporting units and the magnitude of units, up to 28 different combinations may be reported by laboratories. We provide updated findings for D-dimer testing in our geographic region, using recent data from the Royal College of Pathologists of Australasia Quality Assurance Programs, an international external quality assessment program, currently with over 450 participants in the D-dimer module. Data show a wide variety of assays in use and variable outcomes in reported numerical values when assessing proficiency samples. D-dimer testing mostly comprised reagents from three main manufacturing suppliers, with a small number of users of reagents from other manufacturers. Reported results showed important differences in numerical values for the same homogeneous tested samples when normalized to a single reporting unit (e.g., mg/L). Nevertheless, despite using different test reagents and reporting, most participants uniformly identified D-dimer values as below or above a “detection” cut-off for samples that were constructed to be below or above most cut-off values. As expected, mixed findings were reported for samples containing levels around expected cut-off values. We hope that our findings, reflecting on the heterogeneity of test reagents and test data, help improve diagnostic testing for D-dimer testing and facilitate harmonization and standardization, in the future.

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Section: Discussionmentioning

confidence: 99%

Variable Performance of D-dimer Testing by Hemostasis Laboratories: The Australasian/Asia-Pacific Experience

Favaloro,

Arunachalam,

Dean

2024

Semin Thromb Hemost

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D-dimer testing: A narrative review

Wauthier

Favresse

Hardy³

et al. 2023

Advances in Clinical Chemistry

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