scholarly journals Using a fingerstick test for haematological monitoring in patients treated with clozapine

2021 ◽  
Vol 11 ◽  
pp. 204512532110008
Author(s):  
Matthew Atkins ◽  
Philip McGuire ◽  
Bhirundra Balgobin ◽  
Pravinkumar Patel ◽  
David Taylor
Keyword(s):  
Regression Analysis ◽  
Confidence Interval ◽  
Blood Cell ◽  
Point Of Care ◽  
Venous Blood ◽  
Capillary Blood ◽  
Test Results ◽  
Capillary Method ◽  
Capillary Sample ◽  
Venous Sample

Background Treatment with clozapine requires regular blood monitoring in order to minimise the risk of agranulocytosis. The demands on patients and clinicians associated with monitoring may be reduced by using point-of-care, as opposed to lab-based assessments. We assessed the utility of a device that can measure white blood cell (WBC) and neutrophil counts by capillary fingerstick blood. Method The performance of a small, portable device (HemoCue® WBC DIFF System) was compared with that of a widely used laboratory analyser (ADVIA® 2120i) for measuring WBC and neutrophil counts. Patients with schizophrenia who were being treated with clozapine ( n = 201) provided a fingerstick capillary sample and a venous sample for the respective assays. Results WBC counts and neutrophil counts from venous blood as determined by ADVIA 2120i, ranged from 3.0 × 109/l to 19.5 × 109/l, and 1.2 × 109/l to 15.9 × 109/l, respectively. There was a strong correlation between the results from venous and the capillary sample methods (WBC: R = 0.89, neutrophil: R = 0.92). By Passing–Bablok regression analysis, the slope of the association between ADVIA® 2120i and HemoCue WBC DIFF for WBC was 1.0 [95% confidence interval (CI) 0.944–1.086], with intercept at −0.9 (95% CI −1.43 to −0.45). For neutrophils, the slope was 0.870 (95% CI 0.817–0.923), with intercept at −0.19 (95% CI −0.43 to 0.02). Overall, mean biases of −0.95 × 109/l for WBC, and −0.91 × 109/l for neutrophils were observed for the capillary blood method compared with the venous blood method. Below the clinical cutoff intervals for clozapine monitoring WBC (<3.5 × 109/l) and neutrophils (<1.5 × 109/l) these biases were −1.1 × 109/l for WBC, and −0.25 × 109/l for neutrophils. Conclusion Results from the capillary blood HemoCue WBC DIFF analyser compared well with the venous blood ADVIA 2120i analyser for determining WBC and neutrophil counts. There was a slight overall bias, with the capillary method reporting lower values for both measures. Fingerstick point-of-care analysis is suitable for monitoring blood counts in patients on clozapine, although confirmatory standard venous testing is recommended for test results falling below accepted thresholds.

Point-of-care measurement of clozapine concentration using a finger-stick blood sample

2021 ◽  
pp. 026988112199156
Author(s):  
David Taylor ◽  
Matthew Atkins ◽  
Robert Harland ◽  
Irina Baburina ◽  
James H MacCabe ◽  
...  
Keyword(s):  
Blood Sample ◽  
Point Of Care ◽  
Venous Blood ◽  
Laboratory Method ◽  
Capillary Blood ◽  
Strong Positive Correlation ◽  
Blood Samples ◽  
Clozapine Concentration ◽  
Capillary Sample ◽  
Finger Stick

Background: The use of clozapine demands regular monitoring of clozapine plasma concentrations and of white blood cell parameters. The delay between sending blood samples for analysis and receiving the results hinders clinical care. Point-of-care testing (POCT) can provide drug assay results within a few minutes. Aim: This study aimed to investigate the utility of a novel point-of-care device that can measure clozapine concentrations using capillary blood samples collected via a finger stick. Method: During a five-week period starting in June 2019 eligible patients were asked to provide a finger-stick capillary sample in addition to their usual venous blood sample. Samples were analysed by the novel point-of-care device and by the standard laboratory method. Capillary blood samples were tested by the MyCare™ Insite POCT analyser, and a quantitative measurement of clozapine concentration was provided within six minutes. Results: A total of 309 patients agreed to measurements by the two methods. Analysis revealed clozapine concentrations in venous blood as determined by the laboratory method ranged from 20 to 1310 ng/mL and by POCT from 7 to 1425 ng/mL. There was a strong positive correlation ( R = 0.89) between the results from the venous and the capillary sample methods. The slope of the association between standard assay and MyCare™ Insite was 1.0 with an intercept of –21 ng/mL, indicating minimal bias. Conclusion: Clozapine concentrations can be accurately measured at the point of care using capillary blood samples collected via a finger stick. This approach may be more acceptable than venous sampling to patients and, with almost instant results available, more useful to clinicians.

A Comparison of Venous versus Capillary Blood Samples when Measuring Blood Glucose Using a Point-of-Care, Capillary-Based Glucometer

2019 ◽  
Vol 34 (05) ◽  
pp. 506-509
Author(s):  
Jessica Topping ◽  
Matthew Reardon ◽  
Jake Coleman ◽  
Brian Hunter ◽  
Haruka Shojima-Perera ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Point Of Care ◽  
Research Question ◽  
Venous Blood ◽  
Hospital Setting ◽  
Capillary Blood ◽  
Needle Stick Injury ◽  
Blood Samples ◽  
Significant Difference ◽  
Venous Sample

AbstractBackground:Blood glucose level (BGL) is routinely assessed by paramedics in the out-of-hospital setting. Most commonly, BGL is measured using a blood sample of capillary origin analyzed by a hand-held, point-of-care glucometer. In some clinical circumstances, the capillary sample may be replaced by blood of venous origin. Given most point-of-care glucometers are engineered to analyze capillary blood samples, the use of venous blood instead of capillary may lead to inaccurate or misleading measurements.Hypothesis/Problem:The aim of this prospective study was to compare mean difference in BGL between venous and capillary blood from healthy volunteers when measured using a capillary-based, hand-held, point-of-care glucometer.Methods:Using a prospective observational comparison design, 36 healthy participants provided paired samples of blood, one venous and the other capillary, taken near simultaneously. The BGL values were similar between the two groups. The capillary group had a range of 4.3mmol/l, with the lowest value being 4.4mmol/l and 8.7mmol/l the highest. The venous group had a range of 2.7mmol/l, with the lowest value being 4.1mmol/l and 7.0mmol/l the highest.For the primary research question, the mean BGL for the venous sample group was 5.3mmol/l (SD = 0.6), compared to 5.6mmol/l (SD = 0.8) for the capillary group. This represented a statistically significant difference of 0.3mmol/l (P = .04), but it did not reach the a priori established point of clinical significance (1.0mmol/l). Pearson’s correlation coefficient for capillary versus venous indicated moderate correlation (r = 0.42).Conclusion:In healthy, non-fasted people in a non-clinical setting, a statistically significant, but not clinically significant, difference was found between venous- and capillary-derived BGL when measured using a point-of-care, capillary-based glucometer. Correlation between the two was moderate. In this context, using venous samples in a capillary-based glucometer is reasonable providing the venous sample can be gathered without exposure of the clinician to risk of needle-stick injury. In clinical settings where physiological derangement or acute illness is present, capillary sampling would remain the optimal approach.

scholarly journals Point-of-care testing for bacterial infection in diabetic foot ulcers: a prospective cohort study

2020 ◽  
Vol 29 (11) ◽  
pp. 649-657
Author(s):  
Leon Jonker ◽  
Danielle Smith ◽  
Emma Mark ◽  
Jose Schutter ◽  
Sarah Thornthwaite ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Wound Infection ◽  
Diabetic Foot ◽  
Host Response ◽  
Point Of Care ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Test Results ◽  
Infection Detection ◽  
Test Result

Objective: To appraise the performance of a new point-of-care wound infection detection kit in diabetic foot ulcers (DFUs), using clinician opinion as the primary comparator. The proprietary swab-based chromatic Glycologic (Glycologic Ltd., UK) detection kit used in this study is designed to detect host response to pathogenic levels of bacteria in wounds. Method: In high-risk podiatry clinics, patients with DFUs were recruited and infection detection kit test results compared with initial clinician opinion. Chi-squared tests, principal component analysis (PCA) and multiple regression analysis were performed to determine which variables were possibly associated with infection. The variables considered were patients' wound parameters, wider vascular comorbidity and demographics. Results: A total of 136 patients, providing 383 wound swabs, were included in the study. Total agreement in terms of DFU wound assessment for infection—between podiatrists' clinical opinion and Glycologic kit test result—was observed in 79% of cases (301/383). For 56 of the 349 negative infection detection kit test results (16%), podiatrists identified a ‘possible’ or ‘definite’ infection. Conversely, in 14 of the 307 cases (4.6%) where podiatrists deemed the wound ‘not infected’, the infection detection kit test showed a colour change. Regression analysis and PCA showed that clinical signs of wound infection, namely erythema, purulence and odour, were all significantly associated with both a positive clinical opinion and infection detection kit test result. However, in the case of the infection detection kit, a patient's number of lesions and vascular comorbidities were also significantly correlated with a positive test result. Conclusion: A host response to critical pathological levels of bioburden in a wound—as detected with the infection detection kit—may partly be determined by an individual patient's (vascular) health and therefore be person-specific. Further research is indicated to determine the relationship between an infection detection kit test result and the microbiological status of the wound.

scholarly journals Capillary blood tests may overestimate ketosis: triangulation between three different measures of β-hydroxybutyrate

2020 ◽  
Vol 318 (2) ◽  
pp. E184-E188 ◽  
Author(s):  
Jakob Norgren ◽  
Shireen Sindi ◽  
Anna Sandebring-Matton ◽  
Ingemar Kåreholt ◽  
Ulrika Akenine ◽  
...  
Keyword(s):  
Regression Models ◽  
Ketone Body ◽  
Point Of Care ◽  
Venous Blood ◽  
Capillary Blood ◽  
Dietary Interventions ◽  
Healthy Older Adults ◽  
Time Points ◽  
Blood Tests ◽  
Good Agreement

The ketone body β-hydroxybutyrate (BHB), assessed by a point-of-care meter in venous whole blood (BHBv), was used as the main outcome in a study on nutritional ketosis in healthy older adults. Two other BHB measures were also used in the study for validation and exploratory purposes, and here we report findings on correlation and agreement between those three methods. Ketosis in the range of 0–1.5 mmol/L was induced in 15 healthy volunteers by intake of medium-chain fatty acids after a 12-h fast. BHBv was assessed at 12 time points for 4 h. The same point-of-care meter was also used to test capillary blood (BHBc) at three time points, and a laboratory test determined total ketones (TK) in plasma (BHBp + acetoacetate) at four time points. A total of 180 cases included simultaneous data on BHBv, BHBc, BHBp, and TK. TK correlated with BHBp (Pearson’s r = 0.99), BHBv ( r = 0.91), and BHBc ( r = 0.91), all P < 0.0001. BHBv and BHBp had good agreement in absolute values. However, the slope between BHBc and BHBv, measured with the same device, was in the range of 0.64–0.78 in different regression models, indicating substantially higher BHB concentrations in capillary versus venous blood. We conclude that all three methods are valid to detect relative changes in ketosis, but our results highlight the importance of method considerations and the possible need to adjust cutoffs, e.g., in the management of ketoacidosis and in the evaluation and comparison of dietary interventions.

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 A method comparison study of a point-of-care blood gas analyser with a laboratory auto-analyser for the determination of potassium concentrations during hyperkalaemia in patients with kidney disease

2020 ◽  
Vol 30 (3) ◽  
pp. 432-438
Author(s):  
Mogamat-Yazied Chothia ◽  
Patricia Kassum ◽  
Annalise Zemlin
Keyword(s):  
Regression Analysis ◽  
Systematic Error ◽  
Potassium Concentration ◽  
Point Of Care ◽  
Venous Blood ◽  
Mean Difference ◽  
Renal Unit ◽  
Blood Gas ◽  
Altman Analysis ◽  
Bland Altman Analysis

Introduction: Hyperkalaemia is a common electrolyte disorder that may cause life-threatening cardiac arrythmias. We aimed to determine the agreement of potassium concentrations between GEM premier 3500 point-of-care blood gas analyser (POC-BGA) and Roche Cobas 6000 c501 autoanalyser in patients with hyperkalaemia. Methods: A prospective, cross-sectional study of all consecutive adult patients referred to the Renal Unit with a serum potassium concentration ≥ 5.5 mmol/L was performed. A total of 59 paired venous blood samples were included in the final statistical analysis. Passing-Bablok regression and Bland Altman analysis were used to compare the two methods. Results: The median laboratory auto-analyser potassium concentration was 6.1 (5.9-7.1) mmol/L as compared to the POC-BGA potassium concentration of 5.7 (5.5-6.8) mmol/L with a mean difference of - 0.43 mmol/L and 95% upper and lower limits of agreement of 0.35 mmol/L and - 1.21 mmol/L, respectively. Regression analysis revealed proportional systematic error. Test for linearity did not indicate significant deviation (P = 0.297). Conclusion: Although regression analysis indicated proportional systematic error, on Bland Altman analysis, the mean difference appeared to remain relatively constant across the potassium range that was evaluated. Therefore, in patients presenting to the emergency department with a clinical suspicion of hyperkalaemia, POC-BGA potassium concentrations may be considered a surrogate for laboratory auto-analyser measurements once clinicians have been cautioned about this difference.

scholarly journals Head to head comparisons in performance of CD4 point–of-care assays: A Bayesian meta-analysis (2000-2013)

2014 ◽  
Author(s):  
Samantha Wilkinson ◽  
Tiago Chiavegatti ◽  
Benedicte Nauche ◽  
Given Names Deactivated Family Name Deactivated ◽  
Nitika Pant Pai
Keyword(s):  
Flow Cytometry ◽  
Point Of Care ◽  
Meta Analysis ◽  
Venous Blood ◽  
Capillary Blood ◽  
Sufficient Data ◽  
Bayesian Hierarchical ◽  
Cell Counts ◽  
Meta Analyses ◽  
Cd4 Cell

Background: Timely detection, staging, treatment initiation are pertinent to controlling HIV Infection. CD4+ cell-based point-of-care (POC) devices offer the potential to rapidly stage patients, and decide on initiating treatment, but a comparative evaluation of their performance has not yet been performed. With this in mind, we conducted a systematic review and meta-analyses. Methods: For the period Jan 2000 to April 2015, 19 databases were systematically searched, 6619 citations retrieved, and 25 articles selected. Diagnostic performance was compared across devices (i.e., PIMA, CyFlow, miniPOC, MBioCD4 System) and across specimens (i.e., capillary blood vs. venous blood). A Bayesian approach was used to meta-analyze the data. The primary outcome, the Bland-Altman (BA) mean bias (which represents agreement between cell counts from POC device and flow cytometry), was analyzed with a Bayesian hierarchical normal model. Findings: We performed a head-to-head comparison of two point-of-care devices, PIMA and PointCareNOW CD4. PIMA appears to perform better vs. PointCareNOW with venous samples (BA mean bias: -9.5 cells/μL; 95% CrI:-37.71 to 18.27 vs. 139.3 cells/μL; 95% CrI:-0.85 to 267.4, mean difference = 148.8, 95% CrI: 11.8, 285.8); however, PIMA’s best performed when used with capillary samples (BA mean bias: 2.2 cells/μL; 95% CrI:-19.32 to 23.6). Sufficient data was available to allow pooling of sensitivity and specificity data only at the 350 cells/μL cutoff. For PIMA device sensitivity 91.6 (84.7 to 95.5) and specificity was 94.8 (90.1 to 97.3) respectively. There was not sufficient data to allow comparisons between any other devices. Conclusions: PIMA device was comparable to flow cytometry. The estimated differences between the CD4+ cell counts of the device and the reference was small and best estimated in capillary blood specimens. As the evidence stands, the PointCareNOW device will need to improve prior to widespread use and more data on MBio and MiniPOC are needed. Findings inform implementation of PIMA and improvements in other CD4 POC device prior to recommending widespread use.

Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients

2020 ◽  
Author(s):  
Christopher A Jankowski ◽  
Anthony M Casapao ◽  
Sandra Siller ◽  
Carmen Isache ◽  
Kelia V Cani ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Treatment Plan ◽  
Venous Blood ◽  
Chronically Ill ◽  
Capillary Blood ◽  
Care Providers ◽  
Paired Samples ◽  
Capillary Sample ◽  
Blood Specimens ◽  
Chronically Ill Patients

Abstract Objectives Patient compliance with laboratory testing is one of the most underrecognized challenges in developing a treatment plan for acute and chronically ill patients. The ability to offer alternatives to standard venipuncture blood draws would greatly increase a laboratory’s ability to provide testing to patients and health care providers. Methods We performed a prospective observational study on paired venous and fingerstick capillary blood samples from admitted patients undergoing vancomycin therapy. Paired specimens were analyzed for vancomycin and a basic metabolic panel (BMP: calcium, carbon dioxide, chloride, potassium, sodium, creatinine, glucose, serum urea nitrogen) on the core laboratory’s automated chemistry and immunochemistry platforms. Results A total of 59 paired fingerstick and venous blood specimens from 56 unique inpatients were analyzed. Paired samples were comparable for all the analytes tested with the exception of bicarbonate and potassium, which were significantly different among the capillary sample group. Patients required multiple fingers be lanced in 15% of cases to obtain sufficient blood to carry out the testing. Capillary sample rejection rates due to insufficient volumes were as high as 30% in the initial 30 patients enrolled in the study. Conclusions Vancomycin and the BMP, with the exception of potassium and bicarbonate, were determined to be analytically comparable. However, significant preanalytical issues should preclude laboratories and providers from more widespread adoption of fingerstick-derived capillary blood as an alternative sampling method except in the most extenuating of circumstances.

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.

Point-of-care haemoglobin measurement in pooled capillary blood by a portable autoanalyser: comparison with venous blood haemoglobin measured by reference methods in cross-sectional and longitudinal studies

2021 ◽  
pp. 1-27
Author(s):  
Teena Dasi ◽  
Ravindranadh Palika ◽  
Raghu Pullakhandham ◽  
Little Flower Augustine ◽  
Naveen K. Boiroju ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Point Of Care ◽  
Venous Blood ◽  
Cross Sectional Study ◽  
Capillary Blood ◽  
Sectional Study ◽  
Limits Of Agreement ◽  
Cross Sectional ◽  
Reference Methods ◽  
Hb C

Abstract Population-based surveys commonly use point-of-care (POC) methods with capillary blood samples for estimating haemoglobin (Hb) concentrations; these estimates need to be validated by comparison with reference methods using venous blood. In a cross-sectional study in 748 participants (17-86y, 708 women, Hb: 5.1 to 18.2 g/dL) from Hyderabad, India, we validated Hb measured from a pooled capillary blood sample by a POC autoanalyser (Horiba ABX Micros 60OT, Hb-C-AA) by comparison with venous blood Hb measured by two reference methods: POC autoanalyser (Hb-V-AA) and cyanmethemoglobin method (Hb-V-CM). These comparisons also allowed estimation of blood sample related and equipment related differences in the Hb estimates. We also conducted a longitudinal study in 426 participants (17-21y) to measure differences in the Hb response to iron folate treatment by the capillary blood POC method compared to the reference methods. In the cross-sectional study, Bland Altman analyses showed trivial differences between source of blood (Hb-C-AA and Hb-V-AA; mean difference, limits of agreement: 0.1, -0.8 to 1.0 g/dL) and between analytical methods (Hb-V-AA and Hb-V-CM; mean difference, limits of agreement :< 0.1, −1.8 to 1.8 g/dL). Cross-sectional anaemia prevalence estimated using Hb-C-AA did not differ significantly from Hb-V-CM or Hb-V-AA. In the longitudinal study, the Hb increment in response to IFA intervention was not different when using Hb-C-AA (1.6 ± 1.7 g/dL) compared to Hb-V-AA (1.7± 1.7g/dL) and Hb-V-CM (1.7± 1.7 g/dL). The pooled capillary blood–autoanalyzer method (Hb-C-AA) offers a practical and accurate way forward for POC screening of anaemia.

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