Interference of icterus on plasma D-dimer levels measured using immunoturbidimetric assays

Mastella, Aline Klein; Carvalho, José Antônio Mainardi de; Stein, Carolina dos Santos; Bochi, Guilherme Vargas; Moresco, Rafael Noal

doi:10.1097/mbc.0000000000001004

Cited by 5 publications

(4 citation statements)

References 12 publications

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“…For instance, a recent study performed with the STA‐Liatest D‐Di Plus reagent on a STAR MAX 2 analyzer found that D‐dimer values started to increase from 6 g/L of hemoglobin. 26 No impact of icterus was observed up to 300 mg/L of bilirubin, as reported for the VIDAS D‐Dimer Exclusion II reagent and in agreement with Mastella et al, 27 who found no significant change in D‐dimer concentrations up to 300 mg/L of bilirubin. Conversely, lipid concentrations higher than 5 g/L led to an analytical interference, with a negative bias.…”

Section: Discussionsupporting

confidence: 86%

Analytical performance of a new immunoturbidimetric D‐dimer assay and comparison with available assays

Talon

Fourneyron

Trapani

et al. 2022

Research and Practice in Thrombosis and Haemostasis

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Background The routine D‐dimer quantification to exclude venous thromboembolism has led to the development of many assays, the usefulness of which depends on their reliability and performance. Objective We evaluated the analytical performances of the immunoturbidimetric Yumizen G DDi 2 assay (HORIBA Medical, Montpellier, France) performed on the Yumizen G800 analyzer and compared it with other available D‐dimer assays. Methods Within‐run and between‐run imprecision were evaluated using low‐ and high‐level quality‐control plasma samples. Interference due to hemolysis, icterus, lipemia, rheumatoid factor (RF), or heterophilic antibodies (human antimouse antibodies [HAMAs]) was evaluated by spiking plasma samples with hemolysate, bilirubin, Intralipid, RF, or HAMAs. The measurements obtained with the different D‐dimer assays were compared using Passing‐Bablok regression analysis and Bland‐Altman plot method, using fresh citrated plasma samples collected from 66 consecutive routine patients with a wide range of D‐dimer concentrations. Results Within‐ and between‐run variation coefficients for the Yumizen G DDi 2 assay ranged from 1.7% to 5.8% and from 2.8% to 5.5%, respectively. Hemolysis and icterus did not have any effect up to 10 g/L hemoglobin and 300 mg/L bilirubin. Lipemia seemed to generate an underestimation of D‐dimer concentration when the Intralipid concentration was >5 g/L. RF and HAMAs did not have any effect. The Passing‐Bablok and Bland‐Altman analyses showed small differences with other available D‐dimer assays, which were more pronounced with increasing values. Conclusions Its analytical performances and main technical features indicate that the new Yumizen G DDi 2 assay is suitable for the rapid quantification of D‐dimer in clinical hemostasis laboratories.

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Section: Discussionsupporting

confidence: 86%

Analytical performance of a new immunoturbidimetric D‐dimer assay and comparison with available assays

Talon

Fourneyron

Trapani

et al. 2022

Research and Practice in Thrombosis and Haemostasis

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“…After repeated DD evaluations with pathological / undeterminable values without explanation and without attempts to investigate the causes of these abnormal results, we approached the problem by assuming the presence of an analytical interference. Interference from hyperbilirubinemia, hemolysis and hyperlipemia, sometimes reported in literature, were excluded because appearance of the specimen and the results of biochemical tests [6][7][8]25,26]. We therefore considered the presence of an interference sustained by heterophilic antibodies [27,28].…”

Section: Discussionmentioning

confidence: 99%

“…From a general point of view the majority ok these methods use homogeneous sandwiches of monoclonal antibodies to detect specific epitopes on cross-linked D-dimer fragments. The detection methods for D-dimer in the clinical laboratory mainly include immunoturbidimetry, enzyme immunoassays, immunofluorescence and immunochromatography, with the most widely used being immunoturbidimetry [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Interference of Heterophilic Antibody in D-dimer Determination in an Asymptomatic Elderly Woman

Sara,

Elena,

Mara

et al. 2024

IBRR

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Background: D-Dimer is considered a pivotal biomarker in diagnosis of disseminated intravascular coagulation and in differential diagnosis of thrombosis and pulmonary embolism. Case Summary: BL, Caucasian woman, 81 years old, was admitted to hospital, in October 2023, for concussive head trauma after an accidental fall. The patient had a "non-assayable D-Dimer due to excess antigen" utilizing Sysmex Innovance D-dimer using a Sysmex CS 5100 analyser. This abnormal result was firstly observed in March 2022. A second Laboratory confirmed the raised D-dimer concentration. The patient had undergone periodic D-dimer checks which had always confirmed the results and had been treated with a direct FXa inhibitor. Methods: Patient’s samples were tested for D-dimer using different assays and different analysers, moreover sample diluted in phosphate buffer and heterophilic antibodies blocking reagent have been tested. Results: The Sysmex Innovance D-dimer assay gave us, constantly “non-assayable D-dimer due to excess antigen" results; the HemosIL D-dimer HS assay gave us, constantly a raised D-dimer concentration (four to five higher than upper reference values); the Quidel Triage D-dimer gave us, constantly D-dimer normal concentration. Results obtained from dilution curves confirmed the presence of high concentration high avidity heterophilic antibodies. Conclusions: Reports regarding the influence of heterophilic antibodies on the measurement of D‐dimer are quite uncommon in literature however, they constitute a significant potential risk. Interference from heterophile antibodies often has a different impact using different instruments and methods in the measurement of D‐dimer. Using a combination of different assays and analysers, of dilution strategy with heterophilic antibody blockers, and combining laboratory results with clinical examinations and imaging data, we were able to identify the interference and exclude the presence of thrombosis.

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“…The impact of other frequent sources of interference, such as lipemia, icterus, proteinemia (including monoclonal gammopathy) and heterophilic antibodies, is less-documented [ 77 , 84 , 85 , 86 ]. Some studies observed no impact of lipemia and icterus [ 87 , 88 , 89 , 90 , 91 , 92 , 93 ]. Spurious D-dimer results were only observed with the STA reagents (Diagnostica Stago, Asnières sur Seine, France) when adding high concentrations of free bilirubin at 80 mg/dL and above [ 94 ].…”

Section: Pre-analytical Stepmentioning

confidence: 99%

D-dimer Testing in Pulmonary Embolism with a Focus on Potential Pitfalls: A Narrative Review

et al. 2022

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D-dimer is a multifaceted biomarker of concomitant activation of coagulation and fibrinolysis, which is routinely used for ruling out pulmonary embolism (PE) and/or deep vein thrombosis (DVT) combined with a clinical pretest probability assessment. The intended use of the tests depends largely on the assay used, and local guidance should be applied. D-dimer testing may suffer from diagnostic errors occurring throughout the pre-analytical, analytical, and post-analytical phases of the testing process. This review aims to provide an overview of D-dimer testing and its value in diagnosing PE and discusses the variables that may impact the quality of its laboratory assessment.

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Interference of icterus on plasma D-dimer levels measured using immunoturbidimetric assays

Cited by 5 publications

References 12 publications

Analytical performance of a new immunoturbidimetric D‐dimer assay and comparison with available assays

Analytical performance of a new immunoturbidimetric D‐dimer assay and comparison with available assays

Interference of Heterophilic Antibody in D-dimer Determination in an Asymptomatic Elderly Woman

D-dimer Testing in Pulmonary Embolism with a Focus on Potential Pitfalls: A Narrative Review

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