Coaguchek

The National Institute of Cardiology has previously used the CoaguChek® XS Plus system (Roche Diagnostics International Ltd), comparing capillary blood prothrombin time/international normalized ratio (PT/INR) results with those obtained using BCS-XP/Thromborel (Siemens). We assessed the reliability of PT/INR results using the third-generation CoaguChek Pro II system, the CoaguChek XS Plus system, and cobas® t 411 for citrated plasma analysis. Venous and capillary PT/INR were measured (N = 204)...

OBJECTIVES: To evaluate if there is a difference in International Normalized Ratio (INR) readings taken within the 15 second time frame after lancing the finger vs 30-60 seconds of obtaining a blood drop utilizing a CoaguChek® XS Plus point-of-care (POC) INR machine in patients on warfarin therapy. METHODS: All adult patients on anticoagulation therapy with warfarin who were managed in a pharmacist-run anticoagulation clinic were considered for inclusion in the study...

BACKGROUND: Patients with antiphospholipid syndrome (APS) receive anticoagulant therapy with vitamin K antagonists (VKAs) to prevent recurrent thrombosis. VKA treatment requires strict monitoring with an international normalized ratio (INR). It is known that lupus anticoagulants (LAs) can lead to elevated INR results with point-of-care-testing (POCT) devices, which could result in inadequate adaptation of anticoagulant therapy. OBJECTIVE: To determine discrepancies between POCT-INR and laboratory-INR in patients who are LA-positive on VKA therapy...

BACKGROUND: Point-of-care testing (POCT) coagulometers are increasingly used for monitoring warfarin therapy. However, in high international normalized ratio (INR) ranges, significant discrepancy in the INR between POCT and conventional laboratory tests occurs. We compared the INR of POCT (CoaguChek XS Plus; Roche Diagnostics, Mannheim, Germany) with that of a conventional laboratory test (ACL TOP 750; Instrumentation Laboratory SpA, Milan, Italy) and explored possible reasons for discrepancy...

OBJECTIVE: To determine if the CoaguChek® XS-Pro Point-of-Care (POC) device can accurately and precisely measure the international normalized ratio (INR) compared with the gold standard laboratory INR in pediatric and adult patients with liver disease. METHODS: This prospective cohort study included 15 pediatric patients without liver disease, 13 pediatric patients with liver disease, and 17 adult patients with liver disease. The accuracy of the POC INR values was determined using the correlation and Bland-Altman limits of agreement...

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent driving the current COVID-19 pandemic. The acute respiratory distress that occurs in some severe COVID-19 cases has been linked with hypercoagulation or thrombotic events as well as a worse prognosis and increased risk of death. Thus, point-of-care devices that can be used for early detection of coagulation abnormalities would assist in COVID-19 management. This chapter describes the use of the Roche Diagnostics CoaguChek® XS test kit for potential use in COVID-19 personalized medicine approaches...

BACKGROUND: Worldwide, 1 % of the population receives anticoagulation therapy, with prevalence higher in older adults. Difficulties in the adequate management of these patients have led to the development of strategies focused on achieving therapeutic control and reducing adverse events with efficient use of resources. OBJECTIVE: To estimate the cost utility and budget impact on the Argentinean health system of implementation of anticoagulation clinics (ACs) (with and without use of point-of-care [POC] CoaguChek® devices [Roche Diagnostics International Ltd]) compared with the traditional laboratory method (non-AC settings) for the management of anticoagulated patients...

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BACKGROUND: Whole blood point-of-care PT/INR test devices, e.g. CoaguChek XS, are calibrated by their manufacturers. In the Netherlands, each new lot of test strips for CoaguChek XS is validated by a group of anticoagulant clinics collaborating with a Coagulation Reference Laboratory. In 2017, a new International Standard for recombinant human thromboplastin (coded rTF/16) has been established by the World Health Organization. AIM: To assess uncertainty of the validation procedure and the magnitude of the INR bias of a series of consecutive lots of test strips imported in the Netherlands...

INTRODUCTION: We evaluated the analytical performance of CoaguChek Pro II (Roche Diagnostics GmbH, Mannheim, Germany), a new point-of-care device measuring the international normalized ratio (INR) values, in comparison with CoaguChek XS Plus (Roche Diagnostics GmbH) and STA-R Max using STA-Neoplastine CI Plus (Diagnostica Stago SAS, Asnières-sur-Seine, France). METHODS: The precision of Pro II was analyzed, according to the Clinical and Laboratory Standards Institute guidelines (CLSI POCT14-A2 and EP15-A3)...

BACKGROUND AND AIM: The CoaguChek® XS (CCX) is a portable coagulation analyzer that is widely used to monitor prothrombin time (PT) in human patients taking oral anticoagulants. It can also be reliably used for screening dogs when PT is in the normal range. Efficacy of the portable CCX coagulation analyzer was evaluated for testing PT in healthy cats and the normal range was established. MATERIALS AND METHODS: Blood samples of 82 cats were collected from the jugular vein and PT was measured using both the CCX and an automated coagulation analyzer (ACA)...

Edoxaban, alongside other direct oral anticoagulants (DOAC), is increasingly used for prevention of thromboembolism, including stroke. Despite DOAC therapy, however, annual stroke rate in patients with atrial fibrillation remains 1-2%. Rapid exclusion of relevant anticoagulation is necessary to guide thrombolysis or reversal therapy but, so far, no data exists on the effect of edoxaban on available point-of-care test systems (POCT). To complete our previous investigation on global coagulation-POCT for the detection of DOAC, we evaluated whether CoaguChek®-INR (CC-INR) is capable of safely ruling out edoxaban concentrations above the current treatment thresholds of 30/50 ng/mL in a blood sample...

INTRODUCTION:  There are limited publications about the microINR point-of-care (POC) system (iLine Microsystems). The current microINR POC system was compared with the ACL TOP 500 laboratory analyzer (Instrumentation Laboratory) and with the CoaguChek XS POC system (Roche Diagnostics). METHODS:  This study was performed at three United States medical centers. Sixty-eight nonanticoagulated normal donors and 245 warfarin anticoagulated patients were included. Testing was performed in duplicate using capillary blood samples for the POC systems and venous blood samples for the laboratory testing...

BACKGROUND: INR is used to monitor the treatment with vitamin K antagonists. A strategy to reduce waiting times for sampling is to measure INR in a capillary sample using a portable point of care (POC) type coagulometer. AIM: To evaluate the correlation of CoaguChek Pro II™, Xprecia™ and microINR™ with venous INR measured at the clinical laboratory and their ease of use. MATERIALS AND METHODS: Patients provided capillary and venous blood samples for parallel tests comparing Xprecia™ Stride with CoaguChek Pro II™ and with venous INR, microINR™ with CoaguChek Pro IITM and with venous INR...

OBJECTIVE: In January 2018, Roche Diagnostics calibrated CoaguChek XS PT Test Strips to the latest World Health Organization reference preparation. On September 12, 2018, Roche Diagnostics issued an urgent medical device correction statement warning of inaccurate international normalized ratio (INR) results greater than 4.5 and recommended additional confirmatory testing. Eight weeks later, on November 2, the U.S. Food and Drug Administration issued a class I recall of all affected lot numbers...

Coagulopathies in horses are common and potentially life-threatening. In equine field medicine, a portable point-of-care (POC) prothrombin time (PT) testing device could be useful to identify early changes in extrinsic clotting. The CoaguChek-XS (Roche Diagnostics) is a small, portable POC PT analyzer used in human medicine. Our preliminary study assessed the suitability of CoaguChek-XS for testing PT in horses and established the PT reference interval (PT RI) in healthy horses using this instrument. Blood samples collected from 102 healthy and ill horses were analyzed with the CoaguChek-XS and compared to a semi-automated coagulometric analyzer (SACA) as the gold standard...

Using CoaguChek to measure PT-INR and comparing the results with those from the hospital laboratory, some patients get consistent results while others do not. The extent of this problem is unknown. Our study aimed to quantify the between-subject variation of the systematic PT-INR difference between CoaguChek and a hospital laboratory method. We used register data with PT-INR results from both CoaguChek and a hospital laboratory method (STA-SPA+) in samples taken simultaneously from 108 patients. After excluding five patients with outlying results, we used mixed-effects models to estimate individual slopes and intercepts to describe the systematic relationship between the two methods for each patient, and calculated the fraction of patients having a systematic difference greater than 0...

Background In the Netherlands, each new lot of test strips for the CoaguChek XS is validated by a group of collaborating centers. The purpose of this study was to assess the accuracy of the international normalized ratio (INR) measured with consecutive test strip lots and the suitability of frozen plasma pools for accuracy evaluation. Methods Each year, a particular lot of CoaguChek XS test strips is used as reference lot. The reference lots have been validated with the International Standard for thromboplastin rTF/09, yielding a mathematical relationship (R1) between reference lot INR and International Standard INR...

INTRODUCTION: Point-of-care (POC) international normalized ratio (INR) values above an institutional cutoff are confirmed in the laboratory using a gold standard venous specimen. This can be problematic in a pediatric setting. METHOD: In this study, 449 consecutive POC INR results were compared to an INR performed in the laboratory on a capillary citrate specimen collected from the same finger-stick. The results were statistically analyzed. RESULTS: The mean INR values from the CoaguChek XS and laboratory were 2...

<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Hemorrhage is still a common cause of death in trauma. Central lab measured prothrombin time (lab PT) is predictive of low prothrombin concentration and clinical outcome in trauma patients, however, treatment guidance is limited by slow turnaround times. Here, we have preclinically evaluated the potential of a point-of-care prothrombin time test (POC PT) as a faster alternative to identify patients with low prothrombin concentration. METHODS: Human whole blood was serially diluted and prothrombin time measured by POC PT (CoaguChek XS Pro, Roche) and lab PT...