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 ◽  
...  

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.

2018 ◽  
Vol 24 (7) ◽  
pp. 1153-1158 ◽  
Author(s):  
Bushra Moiz ◽  
Anila Rashid ◽  
Muhammad Hasan ◽  
Lena Jafri ◽  
Ahmed Raheem

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.


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.


2020 ◽  
Vol 120 (04) ◽  
pp. 687-691
Author(s):  
Majed A. Refaai ◽  
Vinay Shah ◽  
Ronald Fernando

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.


2019 ◽  
Vol 31 (3) ◽  
pp. 448-452 ◽  
Author(s):  
Noa Berlin ◽  
Efrat Kelmer ◽  
Gilad Segev ◽  
Itamar Aroch ◽  
Gal Kelmer

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.


Author(s):  
Gomathi Ramaswamy ◽  
Kashish Vohra ◽  
Kapil Yadav ◽  
Ravneet Kaur ◽  
Tripti Rai ◽  
...  

Abstract Introduction Globally around 47.4% of children and in India, 58% of children aged 6–59 months are anemic. Diagnosis of anemia in children using accurate technologies and providing adequate treatment is essential to reduce the burden of anemia. Point-of-care testing (POCT) devices is a potential option for estimation of hemoglobin in peripheral and field settings were the hematology analyzer and laboratory services are not available. Objectives To access the validity of the POCTs (invasive and non-invasive devices) for estimation of hemoglobin among children aged 6–59 months compared with hematology analyzer. Methods The study participants were enrolled from the pediatric outpatient department in Haryana, India, from November 2019 to January 2020. Hemoglobin levels of the study participants were estimated in Sahli’s hemoglobinometer and invasive digital hemoglobinometers (DHs) using capillary blood samples. Hemoglobin levels in non-invasive DH were assessed from the finger/toe of the children. Hemoglobin levels measured in POCTs were compared against the venous blood hemoglobin estimated in the hematology analyzer. Results A total of 120 children were enrolled. The mean (SD) of hemoglobin (g/dl) estimated in auto-analyzer was 9.4 (1.8), Sahli’s hemoglobinometer was 9.2 (1.9), invasive DH was 9.7 (1.9), and non-invasive DH was 11.9 (1.5). Sahli’s hemoglobinometer (95.5%) and invasive DH (92.2%) had high sensitivity for the diagnosis of anemia compared with non-invasive DH (24.4%). In contrast, non-invasive DH had higher specificity (96.7%) compared with invasive DH (83.3%) and Sahli’s hemoglobinometer (70%). Invasive DH took the least time (2–3 min) for estimation of hemoglobin per participant, followed by Sahli’s (4–5 min) and non-invasive DH (5–7 min). Conclusion All three POCT devices used in this study are reasonable and feasible for estimating hemoglobin in under-5 children. Invasive DHs are potential POCT devices for diagnosis of anemia among under-5 children, while Sahli’s can be considered as a possible option, where trained and skilled technicians are available. Further research and development are required in non-invasive DH to improve accuracy. Lay summary In India, anemia is a serious public health problem, where 58% of the children aged 6–59 months are anemic. Point-of-care testing (POCT) using digital hemoglobinometers (DHs) has been recommended as one of the key interventions by the Anemia Mukt Bharat program since 2018 in India. These POCT devices are easy to use, less invasive, can be carried to field, require minimal training and results are available immediately. Therefore this study assessed the validity of POCT devices—invasive DH, non-invasive DH and Sahli’s hemoglobinometer among 6–59 months children in facility setting compared with the gold standard hematology analyzer. A total of 120 children under 6–59 months of age were enrolled from the pediatric outpatient department in Haryana, India, from November 2019 to January 2020. The (mean hemoglobin in g/dl) invasive (9.7) and non-invasive DH (11.9) overestimated hemoglobin value, while Sahli’s (9.2) underestimated hemoglobin compared with hematology analyzer (9.4). Invasive DH (92.2%) and Sahli’s hemoglobinometer (95.5%) reported high ability to correctly identify those with anemia compared with non-invasive DH (24.4%). In contrast, non-invasive DH (96.73%) had higher ability to correctly identify those without the anemia compared with invasive DH (83.3%) and Sahli’s (70%).


2020 ◽  
Vol 5 (3) ◽  
pp. 23-30
Author(s):  
Simon Robinson ◽  
Jordan Kirton

<sec id="s1">Introduction: Recognising acute traumatic coagulopathy (ATC) poses a significant challenge to improving survival in emergency care. Paramedics are in a prime position to identify ATC in pre-hospital major trauma and initiate appropriate coagulopathy management. </sec> <sec id="s2">Method: A database literature review was conducted using Scopus, CINAHL and MEDLINE. </sec> <sec id="s3">Results: Two themes were identified from four studies: prediction tools, and point-of-care testing. Prediction tools identified key common ATC markers in the pre-hospital setting, including: systolic blood pressure, reduced Glasgow Coma Score and trauma to the chest, abdomen and pelvis. Point-of-care testing was found to have limited value. </sec> <sec id="s4">Conclusion: Future research needs to explore paramedics using prediction tools in identifying ATC, which could alert hospitals to prepare for blood products for damage control resuscitation. </sec>


2018 ◽  
Vol 26 (4) ◽  
pp. 218-224 ◽  
Author(s):  
Jung Hee Han ◽  
Seongsoo Jang ◽  
Mi-Ok Choi ◽  
Mi-Jeong Yoon ◽  
Seung-Bok Lim ◽  
...  

Background: The confirmation of prothrombin time international normalized ratio by a central laboratory often delays intravenous thrombolysis in patients with acute ischemic stroke. Objectives: We investigated the feasibility, reliability, and usefulness of point-of-care determination of prothrombin time international normalized ratio for stroke thrombolysis. Methods: Among 312 patients with ischemic stroke, 202 who arrived at the emergency room within 4.5 h of stroke onset were enrolled in the study. Patients with lost orders for point-of-care testing for the prothrombin time international normalized ratio or central laboratory testing for the prothrombin time international normalized ratio (n = 47) were excluded. We compared international normalized ratio values and the time interval from arrival to the report of test results (door-to-international normalized ratio time) between point-of-care testing for the prothrombin time international normalized ratio and central laboratory testing for the prothrombin time international normalized ratio. In patients who underwent thrombolysis, we compared the time interval from arrival to thrombolysis (door-to-needle time) between the current study population and historic cohort at our center. Results: In the 155 patients included in the study, the median door-to-international normalized ratio time was 9.0 min (interquartile range, 5.0–12.0 min) for point-of-care testing for the prothrombin time international normalized ratio and 46.0 min (interquartile range, 38.0–55.0 min) for central laboratory testing for the prothrombin time international normalized ratio (p < 0.001). The intraclass correlation coefficient between point-of-care testing for the prothrombin time international normalized ratio and central laboratory testing for the prothrombin time international normalized ratio was 0.975 (95% confidence interval: 0.966–0.982). Forty-nine of the 155 patients underwent intravenous thrombolysis. The door-to-needle time was significantly decreased after implementation of point-of-care testing for the prothrombin time international normalized ratio (median, 23.0 min; interquartile range, 16.0–29.8 vs median, 46.0 min; interquartile range, 33.5–50.5 min). Conclusion: Utilization of point-of-care testing for the prothrombin time international normalized ratio was feasible in the management of patients with acute ischemic stroke. Point-of-care testing for the prothrombin time international normalized ratio was quick and reliable and had a pivotal role in expediting thrombolysis.


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.


2010 ◽  
Vol 56 (10) ◽  
pp. 1618-1626 ◽  
Author(s):  
Una Ø Sølvik ◽  
Per H Petersen ◽  
Grete Monsen ◽  
Anne V Stavelin ◽  
Sverre Sandberg

BACKGROUND Observed differences between results obtained from comparison of instruments used to measure international normalized ratio (INR) have been higher than expected from the imprecision of the instruments. In this study the variation of these differences was divided into subcomponents, and each of the subcomponents was estimated. METHODS Blood samples were collected at 4 different patient visits from each of 36 outpatients who were receiving warfarin treatment and were included in the study. INR was determined on 1 laboratory instrument (STA Compact®) and 3 point-of-care instruments (Simple Simon®PT, CoaguChek®XS, and INRatio™). All 4 INR instruments were compared in pairs. Linear regression was used to correct for systematic deviations. The remaining variation of the differences was subdivided into between-subject, within-subject, and analytical variation in an ANOVA nested design. RESULTS The mean difference between instruments varied between 1.0% and 14.3%. Between-subject variation of the differences (expressed as CV) varied between 3.3% and 7.4%, whereas within-subject variation of the differences was approximately 5% for all 6 comparisons. The analytical imprecision of the differences varied between 3.8% and 8.6%. CONCLUSIONS The differences in INR between instruments were subdivided into calibration differences, between- and within-subject variation, and analytical imprecision. The magnitude of each subcomponent was estimated. Within results for individual patients the difference in INR between 2 instruments varied over time. The reasons for the between- and within-subject variations of the differences can probably be ascribed to different patient-specific effects in the patient plasma. To minimize this variation in a monitoring situation, each site and patient should use results from only 1 type of instrument.


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