What have we learned from coagulation laboratory participation in external quality programs?

Smock, Kristi J.; Moser, Karen

doi:10.1111/ijlh.12998

Cited by 8 publications

(8 citation statements)

References 38 publications

(103 reference statements)

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“…Most international external quality control (EQA) programmes now have established EQA exercises for DOACs and demonstrate a wide implementation of specific DOAC testing in certain regions of the world. [111][112][113][114][115][116][117][118] Nevertheless, in regions where the regulatory authorities have refused the approval of these specific kits, access to drug measurements may be limited to specialized laboratories. In addition, only few undertake the in-house validation of these techniques refraining the clinicians to ask for these specific drug measurements.…”

Section: External Quality Controlmentioning

confidence: 99%

“…6,119 Some international EQA programmes have also undertaken and published studies looking at DOAC interference in haemostasis tests. [111][112][113][114][115][116][117][118] Some have also undertaken studies looking at neutralizing the interference of DOACs in haemostasis tests. 120 Although differences were seen between the various methodologies, reliable and reproducible DOAC levels were measured overall.…”

Section: External Quality Controlmentioning

confidence: 99%

See 1 more Smart Citation

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Adcock²,

et al. 2021

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In 2018, the International Council for Standardization in Hematology (ICSH) published a consensus document providing guidance for laboratories on measuring direct oral anticoagulants (DOACs). Since that publication, several significant changes related to DOACs have occurred, including the approval of a new DOAC by the Food and Drug Administration, betrixaban, and a specific DOAC reversal agent intended for use when the reversal of anticoagulation with apixaban or rivaroxaban is needed due to life-threatening or uncontrolled bleeding, andexanet alpha. In addition, this ICSH Working Party recognized areas where additional information was warranted, including patient population considerations and updates in point-of-care testing. The information in this manuscript supplements our previous ICSH DOAC laboratory guidance document. The recommendations provided are based on (1) information from peer-reviewed publications about laboratory measurement of DOACs, (2) contributing author’s personal experience/expert opinion and (3) good laboratory practice.

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Section: External Quality Controlmentioning

confidence: 99%

Section: External Quality Controlmentioning

confidence: 99%

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Adcock²,

et al. 2021

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“…Smock and Moser included the mention of D-dimer in their recent review of EQA practice. 14 They mentioned data from College of American Pathologists that suggested similar challenges to ours, including bimodal data suggesting confusion regarding reporting units. They also reflected on the lack of standardization and harmonization for D-dimer testing and the challenges to achieving this aim.…”

Section: Discussionmentioning

confidence: 55%

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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“…Plasma levels of coagulation factors and inhibitors were also determined. These included Protein S (coagulometric method), Protein C (chromogenic method), Antithrombin III, and coagulation factors III, V, VII, VIII, IX, X, and XI [13,14]. In addition, prothrombotic factors, such as lupus anticoagulant and anticardiolipin, were also measured.…”

Section: Analysis Of Haemostatic Parameters and Platelet Functionmentioning

confidence: 99%

Platelet Membrane Glycoprofiling in a PMM2-CDG Patient

Papazoglu

Silvera-Ruiz

Salinas-Marín

et al. 2021

J. inborn errors metab. screen.

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Congenital disorders of glycosylation (CDG) are metabolic hereditary diseases caused by defects in the synthesis of glycoconjugates. CDG have been described in sugar-nucleotide biosynthesis and transporter, glycosyltransferases, vesicular transport, as well as in lipid biosynthesis and glycosylphosphatidylinositol anchors. PMM2-CDG is caused by mutations in the phosphomannomutase-2 (PMM2) gene and shows autosomal recessive inheritance. It affects all organs and tissues, ranging from severe psychomotor retardation to moderate intellectual disability. Alterations in the primary haemostatic system have been reported in these patients and they can lead to severe bleeding or excessive thrombosis with subsequent vascular insufficiency. Despite of being the most common CDG, platelet glycosylation and sialylation defects in PMM2-CDG patients remain incompletely characterized. In this study, we applied a lectin-based flow cytometry approach to report the first characterization of the highly glycosylated platelet membrane glycan profile in a PMM2-CDG patient. In the PMM2-CDG patient's platelet samples, a decreased binding of SNA lectin, indicative of reduced terminal α-2-6 sialic acid content, and an increased binding of PNA lectin, suggesting desialylation of β-1-Nacetylgalactosamine residues, were observed. Reduced expression of terminal sialic acids in platelet membrane glycoproteins may contribute to the increased risk of hemorrhage reported in these patients by promoting platelet clearance and thrombocytopenia.

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What have we learned from coagulation laboratory participation in external quality programs?

Cited by 8 publications

References 38 publications

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

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

Platelet Membrane Glycoprofiling in a PMM2-CDG Patient

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