Evaluation of the CoaguChek XS Plus system in a Swiss community setting

Deom, A.; Reber, Guido; Tsakiris, Dimitrios Α.; Hannes, Francoise-Marie; Plesch, Winfried

doi:10.1160/th08-11-0741

Cited by 7 publications

(5 citation statements)

References 2 publications

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“…Studies conducted by Deom et al and Lawrie et al suggested that POC-INR can reliably be used for dosing decision for vitamin K antagonist, 17,18 whereas in a study by Celenza and Skinner, POC-INR testing is accurate to exclude significant coagulopathy, but laboratory INR is still needed to confirm supratherapeutic INR. 13 An another study performed in a setting of anticoagulation clinic revealed that 33% of INR measurements with the POC-INR were different from standard laboratory INR and resulted in different therapeutic decision.…”

Section: Discussionmentioning

confidence: 99%

Prospective Comparison of Point-of-Care Device and Standard Analyzer for Monitoring of International Normalized Ratio in Outpatient Oral Anticoagulant Clinic

Moiz

Rashid

Hasan

et al. 2018

Clin Appl Thromb Hemost

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Point-of-care testing (POCT) coagulometers are increasingly being used in the hospital setting and patients' self-testing. We determined the agreement of prothrombin time international normalized ratio (INR) results by POCT coagulometer and laboratory instrument through a comparative analysis and investigated whether the results of POCT coagulometer can reliably be used without being confirmed by standard laboratory analyzer. A total of 200 INR measurements by POCT coagulometer (CoaguChek XS Pro) and laboratory analyzer (Sysmex CS2000i) were compared using Passing-Bablok regression analysis and Bland-Altman plot. Agreement of the INR measurement was further analyzed in relation to dosing decision. The correlation of INR measurements between CoaguChek XS Pro and Sysmex CS2000i was excellent (correlation coefficient = 0.973). The overall mean difference was 0.21 INR ± 0.32 (range: 1.7-0.44). The mean difference was found to get increased as INR results increased and was 0.09 in the subtherapeutic range (≤1.9 INR), 0.29 INR in the therapeutic range (2.0-3.0 INR), while 0.4 INR in the supratherapeutic range (>3.0 INR). The overall agreement was excellent (κ = 0.916) and overall 11 (5.5%) of 200 INR measurements showed a difference in dosing decision between the 2 instruments. The positive bias of POC-INR is evident in the supratherapeutic range which could affect the dosing decision requiring confirmation with the laboratory INR measurement.

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Section: Discussionmentioning

confidence: 99%

Prospective Comparison of Point-of-Care Device and Standard Analyzer for Monitoring of International Normalized Ratio in Outpatient Oral Anticoagulant Clinic

Moiz

Rashid

Hasan

et al. 2018

Clin Appl Thromb Hemost

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“…The CoaguChek XS Plus system was designed for use in the professional setting, differently from the CoaguChek XS system designed for use in patient-self testing [13]. Several studies have evaluated the clinical use of the CoaguChek XS Plus system [10, 13–17].…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have evaluated the clinical use of the CoaguChek XS Plus system [10, 13–17]. Those studies were performed in different clinical settings using different laboratory-based tests, and only one of them compared the CoaguChek XS Plus system with the Stago coagulation system (Table 2).…”

Section: Discussionmentioning

confidence: 99%

“…Some studies insisted that the CoaguChek XS Plus is a reliable tool and dosing decision for vitamin K antagonist therapy may be safely made based on its INR results [13, 16]. On the contrary, Celenza and Skinner [15] concluded that although POC INR testing is sufficiently accurate to exclude clinically significant coagulopathy, laboratory-based INR measurements are still required to confirm nonnormal POC INR results, particularly in the supratherapeutic range.…”

Section: Discussionmentioning

confidence: 99%

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

Hur

Kim

Park

et al. 2013

BioMed Research International

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Background. Point-of-care testing (POCT) coagulometers are increasingly being used in the hospital setting. We investigated whether the prothrombin time international normalized ratio (INR) results by CoaguChek XS Plus (Roche Diagnostics GmbH, Mannheim, Germany) can be used reliably without being confirmed with the INR results by STA-R system (Diagnostica Stago S.A.S, Asnières sur Seine, France). Methods. A total of 118 INR measurements by CoaguChek XS Plus and STA-R were compared using Passing/Bablok regression analysis and Bland-Altman plot. Agreement of the INR measurements was further assessed in relation to dosing decision. Results. The correlation of INR measurements between CoaguChek XS Plus and STA-R was excellent (correlation coefficient = 0.964). The mean difference tended to increase as INR results increased and was 0.25 INR in the therapeutic range (2.0-3.0 INR). The overall agreement was fair to good (kappa = 0.679), and 21/118 (17.8%) INR measurements showed a difference in dosing decision. Conclusion. The positive bias of CoaguChek XS Plus may be obvious even in the therapeutic INR range, and dosing decision based on the CoaguChek XS Plus INR results would be different from that based on the STA-R results. The INR measurements by POCT coagulometers still need to be confirmed with the laboratory INR measurements.

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“…it was shown that the POCT INR device tested, exhibited positive bias as INR values increased (> 2.O INR) when compared with the clinical laboratory INR measurements. Deom et al and Lawrie et al, in separate studies, suggested that POCT INR measurements can be reliably used for monitoring patients on oral anticoagulant therapy 87,88. However, a study by Celenza and Skinner82 revealed that although the POCT INR is accurate in excluding a significant coagulopathy the clinical laboratory INR is still required to manage a patient with warfarin-associated bleeding or an INR above the therapeutic range (i.e.…”

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confidence: 99%

Point-of-care testing : is it a paradox in international normalised ratio measurements?

Maule

2020

The Journal of Medical Laboratory Science and Technology of Sou

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Point-of-care testing (POCT) in haemostasis has shown a steady state increase in the range of tests available with an exponential increase in the number of tests that are performed annually. The most commonly performed test remains the out of hospital measurement of the international normalised ratio (INR). The INR is used to monitor oral anticoagulation therapy (OAT) with vitamin K antagonists. Such drugs include some of the following: warfarin (Coumadin®), phenprocoumon (Marcumar®) and acenocoumarol (Sintrom®, also sold as other brand names). Contrary to laboratory testing, POCT is often performed by general practitioners (GPs), nurses, pharmacists, patients and other healthcare professionals. In many cases these individuals do not have access to the same support mechanisms that exist in the clinical laboratory regarding strict quality control programmes. When an INR test is performed in the clinical laboratory, it has to be accredited, monitored and inspected. Accreditation is also advisable and part of these requirements is to be involved in external quality assessment (EQA). In the case of POCT haemostasis assays, EQA programmes do exist, however these programmes are still relatively few in number. Over the last decade there has been a significant increase in the scope of POCT, particularly in the field of haemostasis. This brief review summarises POCT in haemostasis, highlighting some of its benefits, challenges and future perspectives, especially with regard to the measurement of the INR.

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Evaluation of the CoaguChek XS Plus system in a Swiss community setting

Cited by 7 publications

References 2 publications

Prospective Comparison of Point-of-Care Device and Standard Analyzer for Monitoring of International Normalized Ratio in Outpatient Oral Anticoagulant Clinic

Prospective Comparison of Point-of-Care Device and Standard Analyzer for Monitoring of International Normalized Ratio in Outpatient Oral Anticoagulant Clinic

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

Point-of-care testing : is it a paradox in international normalised ratio measurements?

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