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.

scholarly journals Performance of the microINR Point-of-Care System Used by Self-Testing Patients: A Multicenter Clinical Trial

TH Open ◽  
2021 ◽  
Vol 05 (04) ◽  
pp. e577-e584
Author(s):  
Majed A. Refaai ◽  
Alan K. Jacobson ◽  
Jack C. Rosenfeld ◽  
Robert R. Orr
Keyword(s):  
Point Of Care ◽  
Venous Blood ◽  
International Normalized Ratio ◽  
System A ◽  
Medical Centers ◽  
Accuracy And Precision ◽  
Self Testing ◽  
Point Of Care System ◽  
Anticoagulated Patients ◽  
Laboratory Analyzer

Abstract Introduction Anticoagulation monitoring is a major practical and clinical challenge. We assessed the performance of the microINR system in patient self-testing (PST). Methods This study was performed at four US medical centers. After the training visit of warfarin anticoagulated patients (n = 117) on microINR system, PST was performed at home and in two visits to the medical centers. At the medical centers, both PST and healthcare professionals (HCPs) performed duplicate tests with the microINR System. A venous blood sample for the laboratory testing was also extracted. Accuracy and precision were assessed. Results The comparison between microINR PST results and microINR HCP results revealed an equivalence with a slope of 1.00 (95% confidence interval [CI]: 1.00–1.00), and an intercept of 0.00 (95% CI: 0.00–0.00). When compared with the laboratory analyzer, microINR PST results also showed good correlation with a slope of 0.94 (95% CI: 0.86–1.04) and an intercept of 0.14 (95% CI: -0.09–0.34). Predicted bias values at international normalized ratio (INR) 2.0, 3.5, and 4.5 were 0% against HCP and ≤2.5% against the laboratory. Analytical agreement with both HCP and laboratory was 100% according to ISO17593 and 99.1 and 100% according to CLSI POCT14 with HCP and laboratory, respectively. Clinical agreement with HCP regarding 2.0–4.0 as INR therapeutic range was 98% (within range). The precision (coefficient of variation) of microINR system used by PST was comparable to HCP. Conclusion The microINR results when used by self-testing patients show satisfactory concordance to both HCP results and laboratory analyzer. The microINR system is adequate for self-testing use.

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.

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.

scholarly journals Point-of-care microvolume cytometer measures platelet counts with high accuracy from capillary blood

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0256423
Author(s):  
William M. Dickerson ◽  
Rebecca Yu ◽  
Helena U. Westergren ◽  
Jonathan Paraskos ◽  
Philipp Schatz ◽  
...  
Keyword(s):  
Point Of Care ◽  
Venous Blood ◽  
Reference Method ◽  
Time Data ◽  
Platelet Recovery ◽  
Blood Samples ◽  
Impedance Analyzer ◽  
Platelet Counts ◽  
Platelet Antibodies ◽  
Care Assessment

Background Point-of-care (PoC) testing of platelet count (PLT) provides real-time data for rapid decision making. The goal of this study is to evaluate the accuracy and precision of platelet counting using a new microvolume (8 μL), absolute counting, 1.5 kg cytometry-based blood analyzer, the rHEALTH ONE (rHEALTH) in comparison with the International Society of Laboratory Hematology (ISLH) platelet method, which uses a cytometer and an impedance analyzer. Methods Inclusion eligibility were healthy adults (M/F) ages 18–80 for donation of fingerprick and venous blood samples. Samples were from a random N = 31 volunteers from a single U.S. site. Samples were serially diluted to test thrombocytopenic ranges. Interfering substances and conditions were tested, including RBC fragments, platelet fragments, cholesterol, triglycerides, lipids, anti-platelet antibodies, and temperature. Results The concordance between the rHEALTH and ISLH methods had a slope = 1.030 and R2 = 0.9684. The rHEALTH method showed a correlation between capillary and venous blood samples (slope = 0.9514 and R2 = 0.9684). Certain interferents changed platelet recovery: RBC fragments and anti-platelet antibodies with the ISLH method; platelet fragments and anti-platelet antibodies on the rHEALTH; and RBC fragments, platelets fragments, triglycerides and LDL on the clinical impedance analyzer. The rHEALTH’s precision ranged from 3.1–8.0%, and the ISLH from 1.0–10.5%. Conclusions The rHEALTH method provides similar results with the reference method and good correlation between adult capillary and venous blood samples. This demonstrates the ability of the rHEALTH to provide point-of-care assessment of normal and thrombocytopenic platelet counts from fingerprick blood with high precision and limited interferences.

Measurement accuracy of two professional-use systems for point-of-care testing of blood glucose

2020 ◽  
Vol 58 (3) ◽  
pp. 445-455
Author(s):  
Annette Baumstark ◽  
Nina Jendrike ◽  
Ulrike Kamecke ◽  
Christina Liebing ◽  
Stefan Pleus ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Point Of Care ◽  
Venous Blood ◽  
Laboratory Method ◽  
Sample Type ◽  
Point Of Care Testing ◽  
Blood Samples ◽  
Testing Procedures ◽  
Grid Analysis ◽  
Error Grid

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.

scholarly journals Fingerstick Precision and Total Error of a Point-of-Care HbA1c Test

2019 ◽  
Vol 14 (5) ◽  
pp. 890-895 ◽  
Author(s):  
William D. Arnold ◽  
Kenneth Kupfer ◽  
Monica Hvidsten Swensen ◽  
Kyle S. Fortner ◽  
Harold E. Bays ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
Total Error ◽  
Venous Blood ◽  
Undiagnosed Diabetes ◽  
Components Of Variance ◽  
Blood Samples ◽  
High Hba1c ◽  
Prior Investigation ◽  
Whole Blood Samples

Background: Point-of-care (POC) HbA1c tests hold the promise of reducing the rates of undiagnosed diabetes, provided they exhibit acceptable analytical performance. The precision and total error of the POC (Afinion™ HbA1c Dx) test were investigated using whole blood samples obtained by fingerstick and venipuncture. Methods: Fingerstick samples spanning the assay range were collected from 61 subjects at three representative POC sites. At each site, six fingerstick samples were obtained from each subject and tested on the POC test across two (Afinion AS100) instruments. Repeatability, between-operator, and between-instrument components of variance were calculated using analysis of variance (ANOVA). Four venous samples (low, threshold, medium, and high HbA1c) were measured in duplicate across three instruments using three reagent lots, twice per day over 20-days. Repeatability, between-run, between-day, between-lot, and between-instrument components of variance were calculated. These fingerstick and venous blood results, combined with estimates of imprecision and bias from a prior investigation, allowed for the calculation of the total coefficient of variation (CV) and total error of the POC test using fingerstick and venous whole blood samples. Results: The total imprecision ranged from 1.30% to 2.03% CV using fingerstick samples and from 1.31% to 1.64% CV using venous samples. The total error ranged from 2.87% to 4.75% using fingerstick samples and from 2.93% to 3.80% using venous samples. Conclusions: The POC test evaluated here is precise across its measuring range using both fingerstick and venous whole blood. The calculated total error of the test is well under the accepted quality requirement of ≤6%.

Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia

2020 ◽  
Vol 66 (6) ◽  
pp. 630-636
Author(s):  
Bhargavi Kamineni ◽  
Anusha Tanniru ◽  
Venkateshwarlu Vardhelli ◽  
Deepak Sharma ◽  
Dinesh Pawale ◽  
...  
Keyword(s):  
Point Of Care ◽  
Low Cost ◽  
Venous Blood ◽  
P Value ◽  
Moderate Degree ◽  
Cross Sectional ◽  
System A ◽  
The Mean ◽  
Sample Transfer ◽  
Severe Hyperbilirubinemia

Abstract Introduction Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. Objective To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry. Design/methods In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. Results Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g. The median age at enrollment was 68.5 h (interquartile range: 48–92). Bilistick was accurate only in 54.5% infants in measuring TB within ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r = 0.457; 95% CI: 0.339–0.561, p value &lt; 0.001). Bland–Altman analysis showed a mean difference of 0.5 mg/dl (SD ± 4.4) with limits of agreement between −8.2 and +9.1 mg/dl. Conclusion Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate.

scholarly journals Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Xiaofan Lu ◽  
Hanxiao Sun ◽  
Haicong Li ◽  
Wei Xia ◽  
Hao Wu ◽  
...  
Keyword(s):  
Point Of Care ◽  
Venous Blood ◽  
Method Comparison ◽  
Hemoglobin Concentration ◽  
Hiv Positive ◽  
Reference Standard ◽  
Blood Samples ◽  
Deming Regression ◽  
Hematology Analyzer ◽  
Hiv Negative

Abstract This study aimed to compare the performance of the BD FACSPresto system with the conventional standard-of-care technologies for the measurement of absolute CD4 count (AbsCD4), CD4 percentage (CD4%) and total hemoglobin concentration (Hb) in capillary and venous blood samples of HIV-negative and HIV-positive subjects. A total of 1304 participants were included in this prospective cohort study. Both venous and capillary blood samples were analyzed using the BD FACSPresto system and the results were compared against the BD FACSCalibur for enumerating AbsCD4 and CD4% and Sysmex XT-4000i hematology analyzer for determining Hb levels. Method comparison studies were performed using Deming regression and Bland–Altman plots. The Deming regression analyses comparing the accuracy of the BD FACSPresto system with the reference standard technologies demonstrated a significant linear correlation between the AbsCD4, CD4%, and Hb values generated by the two platforms. The 95% CI of the slopes for AbsCD4, CD4%, and Hb levels were 0.94–0.99, 0.99–1.01 and 0.86–0.93, respectively (P < 0.001). Bland–Altman plots for AbsCD4, CD4%, and Hb levels demonstrated close agreement between the BD FACSPresto system and the reference standards for all study participants. The performance and accuracy of BD FACSPresto system was comparable to the reference standard technologies. The BD FACSPresto system can be used interchangeably with BD FACSCalibur platform for CD4 and Sysmex XT-4000i hematology analyzer for Hb concentrations in resource-limited settings thus, improving accessibility to point-of-care testing services.

scholarly journals Accuracy and Precision of a Point-of-Care HbA1c Test

2019 ◽  
Vol 14 (5) ◽  
pp. 883-889
Author(s):  
William D. Arnold ◽  
Kenneth Kupfer ◽  
Randie R. Little ◽  
Meera Amar ◽  
Barry Horowitz ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
Venous Blood ◽  
Reference Laboratory ◽  
Test Results ◽  
Blood Samples ◽  
Accuracy And Precision ◽  
The Mean ◽  
Whole Blood Samples ◽  
Highly Correlated

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.

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