Comparison of International Normalized Ratio Measurement between CoaguChek XS Plus and STA-R Coagulation Analyzers

Hur, Mina; Kim, Hyeong-Su; Park, Chul Min; Gioia, Antonio La; Choi, Sang-Gyu; Choi, Jong Hyun; Moon, Hee‐Won; Yun, Yeo‐Min

doi:10.1155/2013/213109

Cited by 19 publications

(20 citation statements)

References 18 publications

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“…In our study, the correlation was also very strong when the CoaguChek XS Plus was compared with the photo‐optical (Sysmex CS‐2100i/CA‐1500) and the mechanical clot detection methods (Thrombolyzer XRC). Previous studies, that compared the CoaguChek XS Plus with photo‐optical (Sysmex analysers) or mechanical clot detection methods (STAGO analysers), found correlation coefficients approximately 0.95‐0.96; however, the CoaguChek XS Plus had never been compared before with different laboratory techniques simultaneously.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies indicated an excellent correlation between photo‐optical and electromechanical coagulation analysers, while the comparison between POC and laboratory or manual INRs showed a certain variability in the results, with potential clinical disagreement and differences in VKA dosing . However, it is not known which test actually correlates better with the overall blood coagulation potential, because these three INR methods have never been compared simultaneously with global coagulation assays.…”

Section: Introductionmentioning

confidence: 99%

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A comparative study using thrombin generation and three different INR methods in patients on Vitamin K antagonist treatment

Riva

Vella

Meli

et al. 2017

Int J Lab Hematology

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Summary Introduction Vitamin K antagonist (VKA) treatment requires routine monitoring using the international normalized ratio (INR). However, different INR assays may vary in their results. The aim of this study was to assess the agreement of three different INR methods, compared with thrombin generation, in patients on VKA treatment. Methods Sixty patients attending the Anticoagulation Clinic at Mater Dei Hospital (Msida, Malta) for VKA monitoring between August and September 2015 were enrolled. The INR was tested using a point‐of‐care (POC) device (CoaguChek XS Plus, Roche Diagnostics) for both capillary and venous blood samples, a photo‐optical (Sysmex CS‐2100i/CA‐1500, Siemens) and a mechanical clot detection system (Thrombolyzer XRC, Behnk Elektronik). All assays used human recombinant thromboplastin as reagent. Thrombin generation was performed using the calibrated automated thrombogram. Results There was a negative curvilinear correlation between the endogenous thrombin potential and different INR assays (r≤−.75) and a strong positive linear correlation between the CoaguChek XS Plus on capillary samples and the other INR methodologies (r≥.96). Conclusion All different INR assays showed good correlation with the thrombin generation potential. The POC INR showed one of the highest correlation coefficients with thrombin generation, confirming the POC devices as an accurate, valid alternative to laboratory INR in VKA patients.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A comparative study using thrombin generation and three different INR methods in patients on Vitamin K antagonist treatment

Riva

Vella

Meli

et al. 2017

Int J Lab Hematology

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“…The blood was sent to the CUMC core laboratory for analysis, on a STA-R system (Diagnostica Stago S.A.S, Asnim, D sur Seine, France) using the STA-Neoplastine CI Plus kit. 12 This test uses a calcium thromboplastin reagent with an ISI of 1.32 to measure the clotting time of the patient's plasma and compares it with that of a normal standard. The test measures the activity of coagulation factors I, II, V, VII, and X as a whole.…”

Section: Core Laboratory Inr Testingmentioning

confidence: 99%

Correlation Between Home INR and Core Laboratory INR in Patients Supported with Continuous-Flow Left Ventricular Assist Devices

Dionizovik-Dimanovski

Levin

Fried

et al. 2015

ASAIO Journal

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It has been well established that patient self-testing (PST) of international normalized ratio (INR) using home monitoring devices increases the average therapeutic time and patient satisfaction. Long-term anticoagulation therapy with warfarin is used in patients with continuous-flow left ventricular assist device (CF-LVAD) to minimize the occurrence of thromboembolic events; however, PST devices have never been tested in patients with CF-LVADs. The purpose of this study was to determine the reliability of the PST device Alere INRatio 2 in patients supported with CF-LVADs. A correlation study was performed in 50 patients with CF-LVAD who were on stable warfarin therapy for a minimum of 3 weeks. Simultaneous INR values were determined from capillary whole blood samples using the Alere PST device and venous blood samples processed in the core laboratory at Columbia University Medical Center. There was a moderate correlation between the venous and the capillary INR values with a correlation coefficient of 0.83. The median difference between the methods was 0.39, with 44 of 50 patients recording higher INRs with Alere. Results remained unchanged after adjusting for use of amiodarone, abnormal hematocrit and liver enzymes, creatinine, and thyroid-stimulating hormone. Point of care testing with Alere correlates moderately well but consistently overestimates INR when compared with conventional laboratory testing in patients with CF-LVAD.

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“…The international normalized ratio (INR) 4 derived from the prothrombin time is commonly used to monitor patients prescribed vitamin K antagonists like warfarin (1,2). Warfarin interferes with the synthesis of the vitamin K-dependent clotting factors II, VII, IX, and X as well as protein C and S (3).…”

mentioning

confidence: 99%

“…Traditional analytical performance studies of POCT INR devices assess device precision and accuracy relative to reference methods and evaluate the data with Bland-Altman plots, Passing-Bablok, or Deming regression analyses (4,5). In response to a recent post-market risk assessment of serious clinical and patient self-monitoring adverse events, the Food and Drug Administration (FDA) proposed more stringent performance expectations for POCT INR devices than those outlined in International Organization for Standardization (ISO) 17593:2007 or CLSI POCT14-A (6)(7)(8).…”

mentioning

confidence: 99%

Application of a Simulation Model to Estimate Treatment Error and Clinical Risk Derived from Point-of-Care International Normalized Ratio Device Analytic Performance

Lyon

Sinha

Lyon

et al. 2017

The Journal of Applied Laboratory Medicine

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Background In 2016, the Food and Drug Administration (FDA) proposed to enhance performance expectations for point-of-care testing (POCT) international normalized ratio (INR) devices relative to International Organization for Standardization (ISO) 17593:2007. The objective of the study was to estimate the frequency of warfarin dosing errors associated with a central laboratory INR method, a POCT INR method, and the proposed FDA performance goals. Methods A data set of INR results (n = 51912) from adult patients with INR ≤4 was used to assess the influence of adding assay imprecision and bias on warfarin dose decisions. The frequency of error in warfarin dose and size of error (≥1 or ≥2 dose categories) was compared using published assay specifications for the Instrumentation Laboratory ACL TOP® and the Roche Diagnostics CoaguChek® XS relative to the proposed FDA guidelines. Results The frequency of warfarin dose misclassification was largely influenced by bias and was not sensitive to assay imprecision. The central laboratory and POCT INR methods met the FDA performance specifications, had equal rates of ≥2 warfarin dose category error, and had statistically different rates of ≥1 warfarin dose category error in large samples (n >250). Conclusions Simulation models are useful tools for evaluating POCT INR assay performance criteria required to achieve the proposed FDA guidelines. This simulation depicted how the Roche Diagnostics CoaguChek XS instrument meets the guideline.

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Comparison of International Normalized Ratio Measurement between CoaguChek XS Plus and STA-R Coagulation Analyzers

Cited by 19 publications

References 18 publications

A comparative study using thrombin generation and three different INR methods in patients on Vitamin K antagonist treatment

A comparative study using thrombin generation and three different INR methods in patients on Vitamin K antagonist treatment

Correlation Between Home INR and Core Laboratory INR in Patients Supported with Continuous-Flow Left Ventricular Assist Devices

Application of a Simulation Model to Estimate Treatment Error and Clinical Risk Derived from Point-of-Care International Normalized Ratio Device Analytic Performance

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