scholarly journals Assessment of the CoaguChek-XS portable prothrombin time point-of-care analyzer for horses

2019 ◽  
Vol 31 (3) ◽  
pp. 448-452 ◽  
Author(s):  
Noa Berlin ◽  
Efrat Kelmer ◽  
Gilad Segev ◽  
Itamar Aroch ◽  
Gal Kelmer
Keyword(s):  
Prothrombin Time ◽  
High Precision ◽  
Point Of Care ◽  
Reference Interval ◽  
Life Threatening ◽  
The Mean ◽  
Preliminary Study ◽  
Coaguchek Xs ◽  
Roche Diagnostics ◽  
Good Agreement

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. There was a significant positive correlation between the 2 measurement methods ( r = 0.765, p < 0.01), and very good agreement, with 97% of the samples falling within limits of agreement. The mean CoaguChek-XS PT coefficient of variation was 0.8%, indicating high precision. With high precision and good agreement with the coagulometric PT, the CoaguChek-XS should be further validated for PT measurement in horses.

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

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Mina Hur ◽  
Hanah Kim ◽  
Chul Min Park ◽  
Antonio La Gioia ◽  
Sang-Gyu Choi ◽  
...  
Keyword(s):  
Point Of Care ◽  
Hospital Setting ◽  
International Normalized Ratio ◽  
Excellent Correlation ◽  
Point Of Care Testing ◽  
Altman Plot ◽  
Ratio Measurement ◽  
The Mean ◽  
Coaguchek Xs ◽  
Roche Diagnostics

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.

Accuracy of the CoaguChek XS for point-of-care international normalized ratio (INR) measurement in children requiring warfarin

2008 ◽  
Vol 99 (06) ◽  
pp. 1097-1103 ◽  
Author(s):  
Karina Black ◽  
Mary Massicotte ◽  
Michelle Bauman ◽  
Stefan Kuhle ◽  
Susan Howlett-Clyne ◽  
...  
Keyword(s):  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Venous Blood ◽  
International Normalized Ratio ◽  
Test Results ◽  
Standard Laboratory ◽  
Limits Of Agreement ◽  
Time Points ◽  
Coaguchek Xs ◽  
Roche Diagnostics

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.

Multicentre ISI assignment and calibration of the INR measuring range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy

2007 ◽  
Vol 97 (05) ◽  
pp. 586-861 ◽  
Author(s):  
Ingrid Leichsenring ◽  
Winfried Plesch ◽  
Volker Unkrig ◽  
Steve Kitchen ◽  
Dianne Kitchen ◽  
...  
Keyword(s):  
Polynomial Regression ◽  
Point Of Care ◽  
Anticoagulation Therapy ◽  
Coagulation Cascade ◽  
Sensitivity Index ◽  
Normal Donor ◽  
Who Guidelines ◽  
Measuring Range ◽  
The Mean ◽  
Coaguchek Xs

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.

Performance of the microINR Point-of-Care System: A Multicenter Clinical Trial

2020 ◽  
Vol 120 (04) ◽  
pp. 687-691
Author(s):  
Majed A. Refaai ◽  
Vinay Shah ◽  
Ronald Fernando
Keyword(s):  
Point Of Care ◽  
Venous Blood ◽  
International Normalized Ratio ◽  
Blood Samples ◽  
System A ◽  
Medical Centers ◽  
Point Of Care System ◽  
Testing Accuracy ◽  
Coaguchek Xs ◽  
Roche Diagnostics

Abstract 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. Accuracy and imprecision were assessed. Results Comparing microINR to ACL revealed a correlation coefficient (r) of 0.973, a slope of 1.00 (95% confidence interval [CI], 0.97–1.03), and an intercept of 0.08 (95% CI, 0.04–0.15). When compared with the CoaguChek XS, r was 0.977 with a slope of 0.92 (95% CI, 0.89–0.94) and an intercept of 0.15 (95% CI, 0.08–0.19). Predicted bias values at international normalized ratio (INR) 2.0, 3.5, and 4.5 were ≤ 5% against both references. Agreement with ACL was 97, 95, and 100% for the INR ranges of < 2.0 ± 0.40, 2.0 to 4.5 ± 20%, and ≥ 4.5 ± 25%, respectively. Agreement for the combined INR ranges was 96% against ACL and > 96% against the CoaguChek XS. The coefficient of variation of the microINR was 5.03% for INR < 2.0 and 4.68% for the therapeutic INR range 2.0 to 3.5. Conclusion The microINR results demonstrate adequate imprecision and accuracy to both ACL and CoaguChek XS. This indicates that monitoring INR by this microINR POC system is reliable and acceptable for the management of warfarin therapy.

Long-term stability and reproducibility of Coagu Chek test strips

2005 ◽  
Vol 93 (06) ◽  
pp. 1189-1192 ◽  
Author(s):  
Martha Hoekstra ◽  
Anton van den Besselaar
Keyword(s):  
Prothrombin Time ◽  
Point Of Care ◽  
Oral Anticoagulant Therapy ◽  
Storage Conditions ◽  
Significance Level ◽  
Test Strips ◽  
The Mean ◽  
Significant Change ◽  
One Year ◽  
The Stability

SummaryWhole-blood point-of-care testing prothrombin time monitors are being used on an increasing scale for the monitoring of oral anticoagulant therapy. These monitors are used with disposable test strips containing tissue factor reagent. The purpose of the present study was to assess the stability of different Coagu-Chek-S strip lots for a period of one year. Ten strip lots introduced successively in the Netherlands were obtained from the manufacturer's representative and stored at 4–8°C. Six deep-frozen pooled plasmas were analyzed for the prothrombin time and INR with the strips at six or seven occasions spread over one year. The test plasmas were recalcified immediately before application to the Coagu Chek-S system. Regression analysis was performed on the clotting times obtained with each plasma. In the majority of cases (i.e. 95%), no significant change was observed at the 5% significance level. A significant change was observed in only 3 cases. In addition, a ranking statistic was used as test of a monotonic relationship in the two-way analysis of variance. The results of the ranking statistic were not significant for any strip lot, indicating that the test strips were stable under these storage conditions. The reproducibility of INR measured with the Coagu Chek-S was assessed. The mean within-run coefficient of variation (CV) of INR ranged from 2.58% to 3.36% (CV). The between-lot variation of the mean INR ranged from 3.2 to 4.5 % (CV). The over-all variation of single INR measurements, i.e. including between-lot and within-lot, ranged from 5.0 to 6.0 % (CV).

Point-of-care monitoring of vitamin K-antagonists: validation of CoaguChek XS test strips with International Standard thromboplastin

2012 ◽  
Vol 65 (11) ◽  
pp. 1031-1035 ◽  
Author(s):  
Anton M H P van den Besselaar ◽  
Nathalie C V Péquériaux ◽  
Marij Ebben ◽  
Joke van der Feest ◽  
Kerst de Jong ◽  
...  
Keyword(s):  
The Netherlands ◽  
Vitamin K ◽  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Capillary Blood ◽  
Blood Samples ◽  
Test Strips ◽  
International Standard ◽  
The Mean ◽  
Coaguchek Xs

AimsMany patients treated with vitamin K-antagonists (VKA) use point-of-care (POC) whole blood coagulometers for self-testing. The majority of patients in the Netherlands use one type of POC coagulometer, that is, the CoaguChek XS. Each new lot of test strips for the CoaguChek XS is validated by a group of collaborating thrombosis centres. We assessed the International Normalised Ratio (INR) differences between each of 51 new lots of test strips and the International Standard for thromboplastin rTF/95 or its successor rTF/09.MethodsEach year, a particular lot of CoaguChek XS test strips was used as reference lot. The reference lot was validated by comparison to the International Standard, yielding a relationship between the reference lot INR and International Standard INR. Successive lots of test strips were compared to the reference lot by three centres using 19–29 capillary blood samples obtained from VKA-treated patients. Each patient provided two blood drops from the same finger prick, one for the reference lot strip and one for the new lot.ResultsThe mean INR differences between each lot and the International Standard varied between −8% and +4%. The mean absolute values of the relative differences varied between 2.4% and 8.1%. There were small but clinically unimportant differences in INR between the first and second drop of blood.ConclusionsAccuracy of CoaguChek XS INR determinations can be assessed by a group of collaborating centres using a limited number of capillary blood samples. As the mean INR differences with the International Standard were smaller than 10%, the lots were approved for use by the Netherlands Thrombosis Services.

Influence of haematocrit on international normalised ratio (INR) differences between a whole blood point-of-care coagulation monitor and reference prothrombin time in plasma

2008 ◽  
Vol 100 (12) ◽  
pp. 1181-1184 ◽  
Author(s):  
Evelina Witteveen ◽  
Felix J. M. van der Meer ◽  
Anton M. H. P. van den Besselaar
Keyword(s):  
Iron Oxide ◽  
Prothrombin Time ◽  
Whole Blood ◽  
Point Of Care ◽  
Reference Interval ◽  
Test Strip ◽  
Iron Oxide Particles ◽  
System A ◽  
Self Testing ◽  
International Normalised Ratio

SummaryThe CoaguChek S system is designed for use in patient self-testing. In this system a whole blood sample without sodium citrate is applied to a test strip containing thromboplastin and iron oxide particles. The detection principle is based on fibrin formation which inhibits and finally stops the movement of the iron oxide particles.In the classic prothrombin time (PT) test,ci-trate plasma is mixed with thromboplastin and an excess of calcium ions. In the monitoring of vitamin K-antagonist (VKA) treatment, all results are expressed on a common scale, i.e. international normalised ratio (INR). In patients on long-term VKA treatment, INRs were determined by the CoaguChek S system and reference methods for the classic PT. Four different CoaguChek S strip lots were evaluated.The difference in INR between the reference PT and the CoaguChek S system was negatively correlated to the haematocrit of the patients. We conclude that INR differences between CoaguChek S and plasma PT may be explained in part by the haematocrit.The magnitude of the effect of haematocrit,within the reference interval of 0.37 - 0.51,on the INR difference was not greater than approximately 10% for the combined data of the four strip lots.A bias of less than 10% seems to be acceptable clinically.

Point-of-care monitoring of oral anticoagulation therapy in children

2009 ◽  
Vol 102 (07) ◽  
pp. 159-165 ◽  
Author(s):  
Anthea Greenway ◽  
Robyn Summerhayes ◽  
Fiona Newall ◽  
Janet Burgess ◽  
Lydia DeRosa ◽  
...  
Keyword(s):  
Prothrombin Time ◽  
Oral Anticoagulation ◽  
Gold Standard ◽  
Clinical Decision Making ◽  
Point Of Care ◽  
Anticoagulation Therapy ◽  
Clinical Decision ◽  
Gold Standard Reference ◽  
Coaguchek Xs ◽  
The Impact

SummaryPoint-of-care (POC) monitoring of oral anticoagulation has been widely adopted in both paediatric and adult patients. A new POC system, the CoaguChek XS® has recently been developed to measure the international normalised ratio (INR) and may offer significant advantages. The CoaguChek XS® utilises a new method of electrochemical clot detection based on thrombin generation. This system has not been previously evaluated in children with reference to the laboratory gold standard, the prothrombin time using reference thromboplastin. It was the objective to compare values obtained by the CoaguChek XS® system with both the venous INR and the gold standard for anticoagulant monitoring, prothrombin time with reference thromboplastin (rTF/95).To evaluate the impact of testing using the Coagu-Chek XS® on clinical anticoagulant dosing decisions. Fifty paired venous INR and capillary CoaguChek XS® results were obtained from 31 children (aged up to 16 years).The laboratory gold standard, a manual prothrombin time with reference thromboplastin (rTF/95) was additionally performed on 26 samples. Correlation between the CoaguChek XS® result and the venous INR was r= 0.810. Agreement between the CoaguChek XS result and the reference INR was shown to be higher (r=0.95), in the subset analysed by this method. Correlation between the venous INR and reference INR was r=0.90. Despite changes to the methodology of testing with the CoaguChek XS® POC monitoring system, the accuracy of this method when compared with both the venous INR and gold standard reference INR was satisfactory. This resulted in infrequent changes to clinical decision making regarding anticoagulation

scholarly journals Establish pre-clinical diagnostic efficacy for parathyroid hormone as a point-of-surgery-testing-device (POST)

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Ambalika S. Tanak ◽  
Sriram Muthukumar ◽  
Ibrahim A. Hashim ◽  
Shalini Prasad
Keyword(s):  
Parathyroid Hormone ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Laboratory Method ◽  
Impedance Change ◽  
Diagnostic Efficacy ◽  
Medical Practitioners ◽  
Targeted Interventions ◽  
Roche Diagnostics ◽  
Good Agreement

Abstract Measuring the Parathyroid hormone (PTH) levels assists in the investigation and management of patients with parathyroid disorders. Rapid PTH monitoring is a valid tool for accurate assessment intraoperatively. Rapid Electro-Analytical Device (READ) is a point-of-care device that uses impedance change between target and capture probe to assess the PTH concentration in undiluted patient plasma samples. The aim of this work focuses on evaluating the analytical performance of READ platform to Roche analyzer as a prospective clinical validation method. The coefficient of variation (CV) for intra-assay imprecision was < 5% and inter-assay imprecision CV was < 10% for high (942 pg/mL) and low (38.2 pg/mL) PTH concentration. Functional sensitivity defined at 15% CV was 1.9 pg/mL. Results obtained from READ platform correlated well (r = 0.99) with commercially available clinical laboratory method (Roche Diagnostics) to measure PTH concentrations with a turn-around time of less than 15 min. Furthermore, the mean bias of 7.6 pg/mL determined by Bland–Altman analysis, showed good agreement between the two methods. We envision such a sensing system would allow medical practitioners to facilitate targeted interventions, thereby, offering an immediate prognostic approach as the cornerstone to delivering successful treatment for patients suffering from primary hyperparathyroidism.

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