Accuracy of Point of Care Testing in Patients on Dual Anticoagulation During Initiation of Anticoagulation or Bridging,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3360-3360
Author(s):  
Anja B Drebes ◽  
Paul Priest ◽  
Shaila Bates ◽  
Lida Moghaddam ◽  
Edward GD Tuddenham ◽  
...  

Abstract Abstract 3360 Background: Point-of-care testing (POCT) is widely used for monitoring of the international normalized ratio (INR) in patients on oral anticoagulation with a vitamin-K antagonist (VKA) and numerous clinical studies have assessed the accuracy of this method in comparison with INR results from venous blood samples analysed in the laboratory. There is however a paucity of clinical data to support the use of POCT in patients on dual anticoagulation with low molecular weight heparin (LMWH) and a VKA during initiation of anticoagulation or bridging after a surgical procedure. Aim: To test the hypothesis whether therapeutic doses of LMWH interfere with INR measurements when using a POCT system during times of dual anticoagulation with LMWH and a VKA. To further investigate whether the effect is most pronounced once LMWH has reached peak plasma levels and less evident 10 hours and more after administration of LMWH. Methods: We prospectively collected 160 consecutive venous blood samples from patients on therapeutic doses of LMWH - Tinzaparin (175 IU/kg once daily) and a VKA commonly warfarin for INR testing in our laboratory. At the same time all patients had their INR determined on capillary blood collected by finger prick using a CoaguChek XS Pro and INR test strips with the same lot number (Roche Diagnostics Ltd, UK). 60 blood samples were collected within 3–6 hours after administration of LMWH (group 1) and 100 samples were collected 10 hours or more after the last injection of LMWH (group 2). For each sample the dose and time of the last injection of LMWH was recorded along with the time of the venepuncture and the result of the capillary INR. To ensure that we had a wide variation in the plasma concentrations of LMWH we carried out anti-Xa testing on a cross-section of venous samples The dosing advice for Warfarin was based on the INR result of the venous blood sample processed in the laboratory. Results: The correlation coefficient between the POCT INR and the laboratory INR was 0.98 in group 1 and 0.97 in group 2. In the Bland Altman analysis for group 1 the mean 95% confidence interval (CI) was 0.03 (range+/− 1.96 SD: −0.26 to +0.32) and for group 2 the mean 95% CI was 0.00 (range −0.28 to +0.29). These results are comparable to results of our internal quality control between POCT INR and laboratory INR in patients on VKA alone with a mean 95% CI of −0.02 (range −0.26 to +0.29). The mean INR was 1.8 by both methods in group 1 and 1.7 by both methods in group 2 and anti-Xa levels ranged from 0 to1.19 U/mL. A variation in the result of the POCT INR and laboratory INR of 0.5 or greater is thought to affect dosing decisions for Warfarin. Such a variation was observed in 3% (2/60) in group 1 and 2% (2/100) in group 2. Conclusion: There was good accuracy of the INR obtained with the POCT system used and this was not affected by the timing of the administration of LMWH in relation to testing. Disclosures: No relevant conflicts of interest to declare.

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 58 (3) ◽  
pp. 445-455
Author(s):  
Annette Baumstark ◽  
Nina Jendrike ◽  
Ulrike Kamecke ◽  
Christina Liebing ◽  
Stefan Pleus ◽  
...  

AbstractBackgroundThe professional-use systems HemoCue® Glucose 201+ (HC201+) and HemoCue® Glucose 201 RT (HC201RT) are widely used for point-of-care testing (POCT) of blood glucose (BG). HC201RT utilizes unit-use microcuvettes which can be stored at room temperature, whereas HC201+ microcuvettes have to be stored at <8 °C. In this study, system accuracy of HC201+ and HC201RT was evaluated using capillary and venous blood samples.MethodsFor each system, two reagent system lots were evaluated within a period of 2 years based on testing procedures of ISO 15197:2013, a standard applicable for self-monitoring of blood glucose (SMBG) systems. For each reagent system lot, the investigation was performed by using 100 capillary and 95 to 99 venous blood samples. Comparison measurements were performed with a hexokinase laboratory method. Accuracy criteria of ISO 15197:2013 and POCT12-A3 were applied. In addition, bias was analyzed according to Bland and Altman, and error grid analysis was performed.ResultsWhen measuring capillary samples, both systems fulfilled accuracy requirements of ISO 15197:2013 and POCT12-A3 with the investigated reagent system lots. When measuring venous samples, only HC201+ fulfilled these requirements. Bias between HC201+ and reference measurements was more consistent over venous and capillary samples and microcuvette lots than for HC201RT. Error grid analysis showed that clinical actions might have been different depending on which system was used.ConclusionsIn this study, HC201+ showed a high level of accuracy irrespective of the sample type (capillary or venous). In contrast, HC201RT measurement results were markedly affected by the type of sample.


1976 ◽  
Vol 81 (3) ◽  
pp. 673-679 ◽  
Author(s):  
Hugo Scaglia ◽  
Martha Medina ◽  
Ada L. Pinto-Ferreira ◽  
Guadalupe Vazques ◽  
Carlos Gual ◽  
...  

ABSTRACT The plasma concentrations and episodic fluctuations of immunoreactive FSH and LH as well as the pituitary sensitivity to LH-RH stimulation were evaluated in post-menopausal women. The subjects were divided into 4 groups according to age. Group 1: 60–70 years old (n=11), group 2: 70–80 years old (n=22), group 3: 80–90 years old (n=31) and group 4: 90–100 years old (n=8). Standards used in gonadotrophin radioimmunoassays included the LER-907 preparation and a pooled post-menopausal serum. Since it was found that circulating gonadotrophins have an immunological pattern different from that shown by the pituitary preparation, the results were expressed in mIU/ml calculated accordingly to the immunological behaviour of pooled post-menopausal sera. The mean (± se) plasma levels of FSH (mIU/ml) were: group 1: 105.9 ± 9.5, group 2: 149.3 ± 10.5, group 3: 124.8 ± 7.1 and group 4: 149.4 ± 25.3. The mean (± se) plasma levels of LH (mIU/ml) were: group 1: 81.9 ± 12.5, group 2: 95.4 ± 9.9, group 3: 84.3 ± 7.7 and group 4: 113.5 ± 19.1. No statistically significant differences were observed among the 4 groups. One patient from each group was randomly selected in order to evaluate their LH and FSH episodic release as well as their pituitary responsiveness to exogenous stimulation. A pulsatile plasma pattern of gonadotrophin and a normal pituitary response to LH-RH injection were observed in the 4 patients studied. The results are interpreted as demonstrating that normal pituitary gonadotrophin function and pituitary reserve and responsiveness to exogenous stimulation are maintained in women of advanced age.


2019 ◽  
Vol 14 (5) ◽  
pp. 883-889
Author(s):  
William D. Arnold ◽  
Kenneth Kupfer ◽  
Randie R. Little ◽  
Meera Amar ◽  
Barry Horowitz ◽  
...  

Background: Point-of-care (POC) hemoglobin A1c (HbA1c) testing has advantages over laboratory testing, but some questions have remained regarding the accuracy and precision of these methods. The accuracy and the precision of the POC Afinion™ HbA1c Dx test were investigated. Methods: Samples spanning the assay range were collected from prospectively enrolled subjects at three clinical sites. The accuracy of the POC test using fingerstick and venous whole blood samples was estimated via correlation and bias with respect to values obtained by an NGSP secondary reference laboratory (SRL). The precision of the POC test using fingerstick samples was estimated from duplicate results by calculating the coefficient of variation (CV) and standard deviation (SD), and separated into its components using analysis of variance (ANOVA). The precision of the POC test using venous blood was evaluated from samples run in four replicates on each of three test cartridge lots, twice per day for 10 consecutive days. The SD and CV by study site and overall were calculated. Results: Across the assay range, POC test results from fingerstick and venous whole blood samples were highly correlated with results from the NGSP SRL ( r = .99). The mean bias was −0.021% HbA1c (−0.346% relative) using fingerstick samples and −0.005% HbA1c (−0.093% relative) using venous samples. Imprecision ranged from 0.62% to 1.93% CV for fingerstick samples and 1.11% to 1.69% CV for venous samples. Conclusions: The results indicate that the POC test evaluated here is accurate and precise using both fingerstick and venous whole blood.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Florian Härtig ◽  
Andreas Peter ◽  
Charlotte Spencer ◽  
Matthias Ebner ◽  
Christine S Zürn ◽  
...  

Introduction: Non-vitamin K antagonist oral anticoagulants (NOAC) are increasingly replacing vitamin K antagonists for prevention of thromboembolism in atrial fibrillation (AF) and venous thrombosis. Ischemic stroke rate in NOAC-treated AF-patients is 1-2% per year. Subsequently, stroke physicians face a growing number of NOAC-treated patients with acute stroke. Rapid assessment of coagulation in NOAC-treated patients is vital prior to thrombolysis, but existing point-of-care testing (POCT) is suboptimal. For the first time we evaluate NOAC-specific POCT. Hypothesis: Ecarin clotting time (ECT)- and anti-Xa activity-POCT accurately predict plasma concentrations of dabigatran and apixaban/edoxaban/rivaroxaban. Methods: 80 patients receiving first NOAC-dose and 80 already on NOAC-treatment will be enrolled (N=40 for each NOAC). Subjects receiving other anticoagulants will be excluded. 6 blood samples will be collected from each patient: before drug intake, 30min, 1, 2, and 8h after intake, and before next dose. NOAC-concentrations will be measured by mass spectrometry. Results (preliminary): Until now 138 blood samples of 23 dabigatran-treated patients were analyzed. Dabigatran-concentrations ranged from 0-371ng/mL. ECT-POCT ranged from 20-219s. Pearson’s correlation coefficient showed strong correlation for ECT-POCT and dabigatran-concentrations (r=0.94, p<0.001). Dabigatran-concentrations >50ng/mL (threshold for thrombolysis according to expert recommendation) were detected by ECT-POCT (>50s) with 100% sensitivity and 82% specificity. Baseline-samples not containing any dabigatran yielded normal ECT-POCT. Conclusions: This is the first study evaluating NOAC-specific POCT. Preliminary results show excellent correlation for ECT-POCT and dabigatran; relevant dabigatran-concentrations were detected in 100%. More pioneering results on NOAC-specific POCT will be presented.


2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Hooman Khorshidi ◽  
Saeed Raoofi ◽  
Rafat Bagheri ◽  
Hodasadat Banihashemi

Objectives. The mechanical properties of membranes are important factors in the success of treatment and clinical handling. The goal of this study was to compare the mechanical properties of early leukocyte- and platelet-rich fibrin (L-PRF) versus PRGF/Endoret membrane.Materials and Methods.In this experimental study, membranes were obtained from 10 healthy male volunteers. After obtaining 20 cc venous blood from each volunteer, 10 cc was used to prepare early L-PRF (group 1) and the rest was used to get a membrane by PRGF-Endoret system (group 2). Tensile loads were applied to specimens using universal testing machine. Tensile strength, stiffness, and toughness of the two groups of membranes were calculated and compared by pairedt-test.Results. The mean tensile strength and toughness were higher in group 1 with a significant difference (P<0.05). The mean stiffness in group 1 was also higher but not statistically significant (P>0.05).Conclusions.The results showed that early L-PRF membranes had stronger mechanical properties than membranes produced by PRGF-Endoret system. Early L-PRF membranes might have easier clinical handling and could be a more proper scaffold in periodontal regenerative procedures. The real results of the current L-PRF should be in fact much higher than what is reported here.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Florian J Härtig ◽  
Andreas Peter ◽  
Charlotte Spencer ◽  
Matthias Ebner ◽  
Christine Meyer-Zuern ◽  
...  

Introduction: Non-vitamin K antagonist oral anticoagulants (NOAC) are increasingly replacing vitamin K antagonists for prevention of thromboembolism in atrial fibrillation (AF). Despite treatment, stroke rate in NOAC-treated AF-patients remains 1-2% per year. Subsequently, stroke physicians face a growing number of NOAC-treated patients with acute stroke. Rapid assessment of coagulation in NOAC-treated patients is vital prior to thrombolysis or reversal therapy, but existing point-of-care testing (POCT) is suboptimal. For the first time we evaluate NOAC-specific POCT. Hypothesis: Ecarin clotting time (ECT)- and anti-Xa activity (ENOX)-POCT predict plasma concentrations of dabigatran and apixaban/edoxaban/rivaroxaban. Methods: 80 patients receiving first NOAC-dose and 80 already on NOAC-treatment are enrolled in the SPOCT-NOAC I trial (N=40 for each NOAC). Subjects receiving other anticoagulants are excluded. Six blood samples are collected from each patient: before drug intake, 30min, 1, 2, and 8h after intake, and before next dose. NOAC-concentrations are measured by mass spectrometry. Results: 240 blood samples of 40 dabigatran-treated patients were analyzed. Dabigatran-concentrations ranged from 0-274ng/mL. ECT-POCT ranged from 20-196s. Pearson’s correlation coefficient showed strong correlation between ECT-POCT and dabigatran-concentrations (r=0.87). Performance was improved through the use of citrated in place of non-citrated whole blood (r=0.93). Dabigatran-concentrations >50ng/mL (threshold for thrombolysis according to expert recommendation) were detected by ECT-POCT >50s with 98% sensitivity and 79% specificity. Baseline-samples not containing any dabigatran yielded normal ECT values. Conclusions: This is the first study evaluating NOAC-specific POCT. Final results in the dabigatran group of SPOCT-NOAC show excellent correlation between ECT-POCT and dabigatran plasma concentrations; performance of ECT-POCT is even increased through the use of citrated whole blood. Relevant dabigatran-concentrations are detected with excellent sensitivity and specificity. In addition to ECT-POCT, we will present data on ENOX-POCT from apixaban-, edoxaban- and rivaroxaban-treated patients.


1989 ◽  
Vol 49 (1) ◽  
pp. 103-107 ◽  
Author(s):  
D. P. Fordham ◽  
G. A. Lincoln ◽  
E. Ssewannyana ◽  
R. G. Rodway

ABSTRACTThe effects of the routine stressful stimuli of handling, transport and slaughter on the plasma concentrations of cortisol and β-endorphin have been studied in lambs. Blood samples were obtained from group 1 lambs after rounding up, after transport and at slaughter. Group 2 lambs were treated similarly except that blood was collected only at slaughter. Group 3 lambs served as controls and were blood sampled twice daily for 5 days to accustom them to handling before being slaughtered. Plasma cortisol and β-endorphin concentrations were increased above control levels by rounding up and transport, and were further increased at slaughter. Group 3 lambs, however, had very much lower β-endorphin levels at slaughter than the other two groups, although their cortisol levels were similar, β-endorphin concentrations declined during the 5-day blood sampling period in group 3 animals but cortisol levels were unchanged. The results suggest that although levels of both hormones are increased by stress, they are not necessarily released concomitantly.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Marija Dionizovik-Dimanovski ◽  
Allison P Levin ◽  
Kanika P Mody ◽  
Erica Simonich ◽  
Justin Fried ◽  
...  

Background: Long-term anticoagulation therapy with warfarin is used in pts. with continuous-flow LVAD (CF-LVAD) to minimize the occurrence of thromboembolic events. Patient self-testing (PST) of INR with home monitoring devices has been shown to improve time within therapeutic INR range as well as patient satisfaction in other settings. However, PST devices have never been tested in pts. with CF-LVADs. The purpose of this study was to determine the reliability of PST devices in patients supported with CF-LVADs. Methods: A correlation study was performed in 50 CF-LVAD pts. who were on stable warfarin therapy for a minimum of 3 weeks. Simultaneous INR values were determined from capillary whole blood samples using the Alere home monitoring PST device and venous blood samples processed in the core laboratory at a large volume CF-LVAD center. Hematocrit, liver function tests, TSH, and amiodarone use were also recorded on patients due to their propensity to affect warfarin metabolism and INR results. Results: Fifty LVAD pts with a mean age of 60 (±14) years were included in the study. Forty-one (82%) were male, and the mean time on CF-LVAD support at the time of INR measurement was 12 months, ranging from 1 to 56 months. There was a moderate correlation between the venous and capillary INR values with a correlation coefficient of 0.83 (r 2 =0.68, p<0.001; Fig 1a). The median difference between the methods was 0.39, with 44/50 pts. having higher INRs with Alere (Fig 1b). Results remained the same after controlling for the use of amiodarone, abnormal hematocrit and liver enzymes, creatinine and TSH. Conclusion: Point of care testing with Alere consistently overestimates INR when compared to conventional laboratory testing in CF-LVAD patients. While our data requires large scale validation, similar results have been reported with point of care testing in other patient populations. Once validated, failure to adjust for this difference may lead to unintentional subterapeutic INR.


2020 ◽  
Vol 3 (4) ◽  
pp. 162-169
Author(s):  
Ahmed Elmelhat ◽  
Essam Elbourai ◽  
Hany Dewedar ◽  
Taghrid Elgergawi ◽  
Maryam Alkhanbouli ◽  
...  

<b><i>Introduction:</i></b> The predominant coagulation abnormalities in patients with coronavirus disease 2019 (COVID-19) suggest a hypercoagulable state and are consistent with uncontrolled clinical observations of an increased risk of venous thromboembolism. <b><i>Aim and Objectives:</i></b> To compare the effect of prophylactic versus therapeutic doses of enoxaparin in the treatment of severe cases of COVID-19 infection. <b><i>Materials and Methods:</i></b> This was a retrospective observational study conducted at Latifa hospital, Dubai. Fifty-nine patients enrolled from March to June 2020 and divided into 2 groups: patients who received the prophylactic dose of enoxaparin (group 1) and patients who received the therapeutic dose of enoxaparin (group 2). <b><i>Results:</i></b> The mean age of all cases was 47.2 ± 10.4 years, while the mean weight was 76.4 ± 13.4 kg. Males represented 79.7% of cases. Blood group “O” was the most frequent blood group (40.9%). None of the cases were smokers or using alcohol. Bronchial asthma, lung diseases, diabetes mellitus, hypertension, CKD, cardiac disease, thyroid disease, and immunodeficiency were present in 1.7, 1.7, 39, 27.1, 5.1, 1.7, 5.1, and 1.7% respectively. There was no significant difference between both study groups regarding personal and medical characteristics, except for hypertension where 35.9% of group 2 (therapeutic) cases were hypertensive compared to 10% of group 1 cases (prophylactic). There was a significant difference between both study groups regarding inflammatory markers improvement duration, duration of MV and O<sub>2</sub> support duration, with longer duration among (therapeutic) group 2 cases compared to group 1 cases (prophylactic). There was a highly significant difference between both study groups regarding ICU admission, as 64% of group 1 cases were admitted compared to 25% of group 1 cases. Similarly, 38.5% of group 2 cases needed MV compared to only 10% of group 1 cases, which was statistically significant. There was no significant difference between both groups regarding bleeding tendency and mortality (<i>p</i> value 0.54). <b><i>Conclusion:</i></b> Our results showed that use of prophylactic dose of enoxaparin might have some benefits compared to the therapeutic dose in terms of less duration of ICU and hospital stay, duration of oxygen support, need and duration of MV, and normalization of inflammatory markers. However, there was no significant difference between the 2 regimens regarding the mortality.


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