European Concerted Action on Anticoagulation. Use of Plasma Samples to Derive International Sensitivity Index for Whole-Blood Prothrombin Time Monitors

Poller, L.; Keown, Michelle; Chauhan, Nikhil; Besselaar, A.M.H.P. van den; Meeuwisse-Braun, J.; Tripodi, Armando; Clerici, M.; Jespersen, Jørgen

doi:10.1093/clinchem/48.2.255

Cited by 23 publications

(11 citation statements)

References 6 publications

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“…It is the ISI value that can be calibrated. It is possible to calibrate CoaguChek with whole blood, fresh, citrated plasma [77–79], and even lyophilized plasma [80].…”

Section: Resultsmentioning

confidence: 99%

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Precision and accuracy of point‐of‐care testing coagulometers used for self‐testing and self‐management of oral anticoagulation therapy

Christensen

Larsen

2012

Journal of Thrombosis and Haemostasis

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To cite this article: Christensen TD, Larsen TB. Precision and accuracy of point-of-care coagulometers used for self-testing and self-management of oral anticoagulation therapy. J Thromb Haemost 2012; 10: 251-60.Summary. Background: Oral anticoagulation therapy is monitored by the use of the International Normalized Ratio (INR). Patients who perform self-testing or self-management use a point-of-care testing (POCT) coagulometer (INR monitor) to estimate their INRs. A precondition for a correct dosage of coumarins is a correct INR estimation, and the method and apparatus used for providing the INR measurements are crucial in this context. Several studies have been published regarding the precision and accuracy of these POCT coagulometers, and have led to diverse conclusions. It is difficult and challenging to perform an overview of the literature, owing to the vast amount of papers, with differences in design, statistical analysis, etc. Objectives: The aim of this systematic review was to analyze the current literature, especially regarding the precision and accuracy of the POCT coagulometers, to provide recommendations for clinical use and quality control, and to point out areas for future research. Methods: We included a total of 22 studies, of which four were characterized as high-quality studies. Results: The precision of the POCT coagulometers was generally adequate for clinical use. Their performance in terms of accuracy has to be viewed in the context of the inherent inaccuracies of INR measurements. Conclusions: The accuracy of POCT coagulometers seems, in this respect, to be generally acceptable, and they can be used in a clinical setting.

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“…It is the ISI value that can be calibrated. It is possible to calibrate CoaguChek with whole blood, fresh, citrated plasma [77–79], and even lyophilized plasma [80].…”

Section: Resultsmentioning

confidence: 99%

“…It has been suggested that calibration of the POCT coagulometers should and could be performed [4,78,79,96] in order to provide accurate INR measurements [83]. Although possible, this does not seem feasible.…”

Section: Discussionmentioning

confidence: 99%

Precision and accuracy of point‐of‐care testing coagulometers used for self‐testing and self‐management of oral anticoagulation therapy

Christensen

Larsen

2012

Journal of Thrombosis and Haemostasis

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“…Serum and citrated (3.2%; BD Vacutainer, Franklin Lakes, NJ) plasma samples were obtained from the same three donors. Citrated plasma (100 μl) was mixed 1:1 with VBS ++ buffer supplemented to 16.3 mM calcium chloride to induce coagulation as described (Poller et al, 2002). Serum and coagulated plasma samples were allowed to clot overnight at 4°C.…”

Section: Plasma Preparationmentioning

confidence: 99%

Fluorochrome-linked immunoassay for functional analysis of the mannose binding lectin complement pathway to the level of C3 cleavage

Walsh

Shaffer

Guikema

et al. 2007

Journal of Immunological Methods

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The humoral response to invading pathogens is mediated by a repertoire of innate immune molecules and receptors able to recognize pathogen-associated molecular patterns. Mannose binding lectin (MBL) and ficolins are initiation molecules of the lectin complement pathway (LCP) that bridge innate and adaptive immunity. Activation of the MBL-dependent lectin pathway, to the level of C3 cleavage, requires functional MASP-2, C2, C4 and C3, all of which have been identified with genetic polymorphisms that can affect protein concentration and function. Current assays for MBL and MASP-2 lack the ability to assess activation of all components to the level of C3 cleavage in a single assay platform. We developed a novel, low volume, fluorochrome linked immunoassay (FLISA) that quantitatively assesses the functional status of MBL, MASP-2 and C3 convertase in a single well. The assay can be used with plasma or serum. Multiple freeze/thaw cycles of serum does not significantly alter the assay, making it ideal for high throughput of large sample databases with minimal volume use. The FLISA can be used potentially to identify specific human disease correlations between these components and clinical outcomes in already established databases.

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“…In some POCT systems, it is possible to use recalcified citrated plasma substituting whole blood for ISI assignment. 54 In the same way, recalcified plasma can be used for quality control of these POCT systems. It should be noted, however, that recalcified plasma cannot be used in all POCT systems, for example, those based on reflection of light by erythrocytes.…”

Section: Poct Quality Controlmentioning

confidence: 99%

Oral Anticoagulant Monitoring by Laboratory or Near-Patient Testing: What a Clinician Should Be Aware Of

Tripodi

Breukink-Engbers

Besselaar

2003

Seminars in Vascular Medicine

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Prothrombin time (PT) is the primary laboratory test for monitoring oral anticoagulant treatment but is influenced by preanalytical conditions and analytical variables, that is, thromboplastin reagents and instrumentation. Standardization and normalization of test results is mandatory. PT results should be transformed to International Normalized Ratio (INR) by calibration of the reagent/instrument system with International Reference standards according to World Health Organization guidelines. However, there is still uncertainty in the INR that is caused in part by calibration errors and in part by interaction between the PT reagent and various factors in the patient's specimen. These problems are highlighted in INR measurements performed with whole blood coagulation monitors. Each center should maintain an appropriate scheme of internal and external quality control for the laboratory INR measurement as well as the individual point-of-care coagulation monitors used by the center and patients for self-testing.

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European Concerted Action on Anticoagulation. Use of Plasma Samples to Derive International Sensitivity Index for Whole-Blood Prothrombin Time Monitors

Cited by 23 publications

References 6 publications

Precision and accuracy of point‐of‐care testing coagulometers used for self‐testing and self‐management of oral anticoagulation therapy

Precision and accuracy of point‐of‐care testing coagulometers used for self‐testing and self‐management of oral anticoagulation therapy

Fluorochrome-linked immunoassay for functional analysis of the mannose binding lectin complement pathway to the level of C3 cleavage

Oral Anticoagulant Monitoring by Laboratory or Near-Patient Testing: What a Clinician Should Be Aware Of

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