Acceptability of CoaguChek S and CoaguChek XS generated international normalised ratios against a laboratory standard in a paediatric setting

Pathology ◽  
2007 ◽  
Vol 39 (6) ◽  
pp. 575-579 ◽  
Author(s):  
Vaughan K. Williams ◽  
Adrian B.M. Griffiths
Keyword(s):  
2017 ◽  
Vol 472 ◽  
pp. 139-145 ◽  
Author(s):  
Wendy S. Baker ◽  
Kathleen J. Albright ◽  
Megan Berman ◽  
Heidi Spratt ◽  
Peggy A. Mann ◽  
...  

2014 ◽  
Vol 29 (1) ◽  
pp. 28-31 ◽  
Author(s):  
Sue Jung Kim ◽  
Eun Young Lee ◽  
Rojin Park ◽  
Juwon Kim ◽  
Jaewoo Song

2008 ◽  
Vol 99 (06) ◽  
pp. 1097-1103 ◽  
Author(s):  
Karina Black ◽  
Mary Massicotte ◽  
Michelle Bauman ◽  
Stefan Kuhle ◽  
Susan Howlett-Clyne ◽  
...  

SummaryPoint-of-care INR (POC INR) meters can provide a safe and effective method for monitoring oral vitamin K antagonists (VKAs) in children. Stollery Children’s Hospital has a large POC INR meter loan program for children requiring oral VKAs. Our protocol requires that POC INR results be compared to the standard laboratory INR for each child on several consecutive tests to ensure accuracy of CoaguChek XS® (Roche Diagnostics, Basel Switzerland) meter. It was the objective of the study to determine the accuracy of the CoaguChek XS by comparing whole blood INR results from the CoaguChek XS to plasma INR results from the standard laboratory in children. POC INR meter validations were performed on plasma samples from two time points from 62 children receiving warfarin by drawing a venous blood sample for laboratory prothrombin (PT)-INR measurements and simultaneous INR determinations using the POC-INR meter. Agreement between CoaguChek XS INR and laboratory INR was assessed using Bland-Altman plots. Bland-Altman's 95% limits of agreement were 0.11 (-0.20; 0.42) and 0.13 (-0.22; 0.48) at the two time points, respectively. In conclusion, the CoaguChek XS meter appraisal generates an accurate and precise INR measure in children when compared to laboratory INR test results.


2010 ◽  
Vol 32 (6p1) ◽  
pp. e248-e250
Author(s):  
K. H. Son ◽  
C. B. Ahn ◽  
H. An ◽  
G. Choe ◽  
S. H. Lee ◽  
...  
Keyword(s):  

2014 ◽  
Vol 13 (2) ◽  
pp. 88-93 ◽  
Author(s):  
André Camacho Oliveira Araújo ◽  
Rodrigo Borges Domingues ◽  
Bonno van Bellen

CONTEXT: Anticoagulation with warfarin is considered the appropriate treatment for venous thromboembolism and other thrombotic pathologies. Regular INR control is required for dosage adjustment and therapeutic control. Use of portable monitoring systems optimizes management of these patients. OBJECTIVE: To compare INR measurements taken using the portable Coaguchek XS system in capillary blood with the standard laboratory method using venous blood. METHOD: Fifty-two samples each of venous and capillary blood were collected from nineteen patients on warfarin, who had been admitted to the Hospital da Beneficência Portuguesa de São Paulo, and analyzed using the conventional method and the Coaguchek XS system, respectively. RESULTS: Spearman's correlation coefficient ® for the overall performance of the two methods was 0.978 (p<0.0001; 95%CI 0.961-0.988). The Kappa measure of agreement for all patients was 76.8% (p<0.001; IC: 95% 0.975-0.561). Mean INR according to the Coaguchek XS system underestimated the values provided by the conventional method by -0.01 INR points, with a standard error of 0.342. Results for INR values greater than 3.5 were satisfactory with a correlation coefficient of 0.71, but without statistical significance (p>0.714). CONCLUSIONS: The Coaguchek XS system can be used to monitor prothrombin time in patients on oral anticoagulants, provided INR values greater than 3.5 are confirmed using the conventional laboratory method.


2008 ◽  
Vol 65 (6) ◽  
pp. 471 ◽  
Author(s):  
Rojin Park ◽  
Yong-Hyun Kim ◽  
Kyung Ock Kwon ◽  
Jongsung Na ◽  
Yong Soon Won ◽  
...  

2015 ◽  
Vol 114 (12) ◽  
pp. 1260-1267
Author(s):  
Joseph S. Biedermann ◽  
Marieke J. H. A. Kruip ◽  
A. M. H. P. van den Besselaar

SummaryMany patients treated with vitamin K antagonists (VKA) determine their INR using point-of-care (POC) whole blood coagulation monitors. The primary aim of the present study was to assess the INR within-subject variation in self-testing patients receiving a constant dose of VKA. The second aim of the study was to derive INR imprecision goals for whole blood coagulation monitors. Analytical performance goals for INR measurement can be derived from the average biological within-subject variation. Fifty-six Thrombosis Centres in the Netherlands were invited to select self-testing patients who were receiving a constant dose of either acenocoumarol or phenprocoumon for at least six consecutive INR measurements. In each patient, the coefficient of variation (CV) of INRs was calculated. One Thrombosis Centre selected regular patients being monitored with a POC device by professional staff. Sixteen Dutch Thrombosis Centres provided results for 322 selected patients, all using the CoaguChek XS. The median within-subject CV in patients receiving acenocoumarol (10.2 %) was significantly higher than the median CV in patients receiving phenprocoumon (8.6 %) (p = 0.001). The median CV in low-target intensity acenocoumarol self-testing patients (10.4 %) was similar to the median CV in regular patients monitored by professional staff (10.2 %). Desirable INR analytical imprecision goals for POC monitoring with CoaguChek XS in patients receiving either low-target intensity acenocoumarol or phenprocoumon were 5.1 % and 4.3 %, respectively. The approximate average value for the imprecision of the CoaguChek XS, i. e. 4 %, is in agreement with these goals.


2007 ◽  
Vol 97 (05) ◽  
pp. 586-861 ◽  
Author(s):  
Ingrid Leichsenring ◽  
Winfried Plesch ◽  
Volker Unkrig ◽  
Steve Kitchen ◽  
Dianne Kitchen ◽  
...  

SummaryThe new CoaguChek XS system is designed for use in patient selftesting. It is the successor of the current CoaguChek S system. The detection principle is based on the amperometric measurement of the thrombin activity initiated by starting the coagulation cascade using a human recombinant thromboplastin. This study was performed to assign the International SEnsitivity Index (ISI) to the new test according to the WHO guidelines for thromboplastins and plasmas used to control anticoagulant therapy, and to establish the measuring range of the new system. At four study sites a total of 90 samples of normal donors and 291 samples of warfarin-, phenprocoumon- or acenocoumarol-treated patients were included in the study.The ISI value of the new test was assigned against the human recombinant reference thromboplastin rTF/95 at each site using the samples from stabilized patients in the International Normalized Ratio (INR) range between 1.5 and 4.5 only. The new point-of-care system’s measuring range between 0.8 and 8 INR was calibrated against the mean INR of rTF/95 and AD149 using polynomial regression. ISIs were (CV of the slope): Site 1: ISI 0.99 (1.1%); Site 2: ISI 1.02 (2.0%); Site 3: ISI 1.03 (1.1%); Site 4: ISI 1.00 (1.4%). All regression lines calculated from patient-only data pass through the normal donor data points.All CVs of the slopes of the orthogonal regression lines are well below 3%,thus fulfilling the requirements of the WHO guidelines. The mean ISI for the new CoaguChek XS PT Test is 1.01.


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