Analytical performance and clinical results of a fully automated MEIA system for brain natriuretic peptide assay: comparison with a point of care testing method

2004 ◽  
Vol 42 (10) ◽  
Author(s):  
Simona Storti ◽  
Concetta Prontera ◽  
Michele Emdin ◽  
Claudio Passino ◽  
Paola Prati ◽  
...  
Keyword(s):  
Brain Natriuretic Peptide ◽  
Natriuretic Peptide ◽  
Point Of Care ◽  
Clinical Results ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Testing Method ◽  
Significant Bias ◽  
Microparticle Enzyme Immunoassay ◽  
Method R

AbstractThe aim of this study was to evaluate the analytical performance of a recently available immunoassay for brain natriuretic peptide (BNP), based on microparticle enzyme immunoassay (MEIA, AxSYM System, Abbott Laboratories), whose analytical characteristics and clinical results were compared with those of a point of care testing (POCT) method (TRIAGE system, Biosite Diagnostics). The within-run and total imprecision of the MEIA system were 18.4% and 19.8% at 21 ng/l, 8.0% and 14.8% at 183 ng/l, and 5.7% and 14.0% at 319 ng/l, respectively. The detection limit of the MEIA system was tested by repeatedly measuring (n = 20) the 0 calibrator in four different runs; a mean +3 SD value of 5.6 ± 4.8 ng/l (range 1.8–12.6 ng/l) was obtained. A close linear relationship (MEIA = –22.5 + 1.71 POCT method, R = 0.950, n = 296) was found (BNP concentration: 5–5500 ng/l), with a significant bias (mean difference: 164.8 ng/l, p < 0.0001). Mean BNP concentration measured in 94 reference subjects (57 women and 37 men; mean age 43.5 ± 14.0 years) was higher with MEIA than POCT, (25.9 ± 32.7 ng/l vs. 11.7 ± 8.9 ng/l, p < 0.0001). The same trend was observed also in 202 cardiac patients (620.6 ± 1082.2 ng/l vs. 386.1 ± 594.5 ng/l, p < 0.0001). Our data suggest that MEIA and POCT have quite similar analytical performance but different clinical results. Then, different reference values, as well as cut-off values, should be taken into account for the clinical use of these two immunoassays.

scholarly journals A systematic evaluation of immunoassay point-of-care testing to define impact on patients’ outcomes

2017 ◽  
Vol 54 (4) ◽  
pp. 420-431 ◽  
Author(s):  
Valentina Pecoraro ◽  
Giuseppe Banfi ◽  
Luca Germagnoli ◽  
Tommaso Trenti
Keyword(s):  
Brain Natriuretic Peptide ◽  
Natriuretic Peptide ◽  
Sensitivity And Specificity ◽  
Point Of Care ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
C Reactive Protein ◽  
Neutrophil Gelatinase Associated Lipocalin ◽  
Reactive Protein ◽  
Neutrophil Gelatinase

Background Point-of-care testing has been developed to provide rapid test results. Most published studies focus on analytical performance, neglecting its impact on patient outcomes. Objective To review the analytical performance and accuracy of point-of-care testing specifically planned for immunoassay and to evaluate the impact of faster results on patient management. Methods A search of electronic databases for studies reporting immunoassay results obtained in both point-of-care testing and central laboratory scenarios was performed. Data were extracted concerning the study details, and the methodological quality was assessed. The analytical characteristics and diagnostic accuracy of six points-of-care testing: troponin, procalcitonin, parathyroid hormone, brain natriuretic peptide, C-reactive protein and neutrophil gelatinase-associated lipocalin were evaluated. Results A total of 116 scientific papers were analysed. Studies measuring procalcitonin, parathyroid hormone and neutrophil gelatinase-associated lipocalin reported a limited impact on diagnostic decisions. Seven studies measuring C-reactive protein claimed a significant reduction of antibiotic prescription. Several authors evaluated brain natriuretic peptide or troponin reporting faster decision-making without any improvement in clinical outcome. Forty-four per cent of studies reported analytical data, showing satisfactory correlations between results obtained through point-of-care testing and central laboratory setting. Half of studies defined the diagnostic accuracy of point-of-care testing as acceptable for troponin (median sensitivity and specificity: 74% and 94%, respectively), brain natriuretic peptide (median sensitivity and specificity: 82% and 88%, respectively) and C-reactive protein (median sensitivity and specificity 85%). Conclusions Point-of-care testing immunoassay results seem to be reliable and accurate for troponin, brain natriuretic peptide and C-reactive protein. The satisfactory analytical performance, together with an excellent practicability, suggests that it could be a consistent tool in clinical practice, but data are lacking regarding the patient outcomes.

scholarly journals Evaluation of point-of-care testing for brain natriuretic peptide in the out-patient clinic

2015 ◽  
Vol 24 ◽  
pp. S79
Author(s):  
M. Matthews ◽  
R. Doughty ◽  
H. McGrinder ◽  
J. Hannah ◽  
A. Meisner
Keyword(s):  
Brain Natriuretic Peptide ◽  
Natriuretic Peptide ◽  
Point Of Care ◽  
Point Of Care Testing

scholarly journals Comparison of a Fully Automated Immunoassay with a Point-of-Care Testing Method for B-Type Natriuretic Peptide

2005 ◽  
Vol 51 (7) ◽  
pp. 1274-1276 ◽  
Author(s):  
Concetta Prontera ◽  
Simona Storti ◽  
Michele Emdin ◽  
Claudio Passino ◽  
Luc Zyw ◽  
...  
Keyword(s):  
Natriuretic Peptide ◽  
Point Of Care ◽  
Point Of Care Testing ◽  
Testing Method ◽  
Automated Immunoassay

Performance Evaluation and Multicenter Consistency Study of Smartphone-based Hipee S2 Point-of-care Testing Urine Dipstick Analyser: Evaluation Study (Preprint)

2021 ◽  
Author(s):  
Qiang Zhang ◽  
Guoqing Wang ◽  
Xiaolong Zong ◽  
Jinghua Sun
Keyword(s):  
Health Management ◽  
Clinical Performance ◽  
Point Of Care ◽  
Method Comparison ◽  
Evaluation Study ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Urine Dipstick ◽  
Quantitative Results ◽  
Carry Over

BACKGROUND With advances in mobile technology, smartphone-based point-of-care testing (POCT) urinalysis hold great potential for disease screening and health management for clinicians and individual users. The POCT devices need to have good analytical and clinical performance, but data are lacking. OBJECTIVE The purpose of this study is to evaluate the analytical performance of smartphone-based Hipee S2 POCT urine dipstick analyser. METHODS A total of 1,603 urine samples from three hospitals were collected. Precision, drift, carry-over, interference, and method comparison of Hipee S2 were evaluated. RESULTS The precision for each parameter, assessed by control materials, was acceptable. No sample carry-over or drift was observed. Ascorbate solution with 1 g/L had an inhibitory effect for the haemoglobin test. Agreement for specific gravity (SG) varied between moderate to substantial, for pondus hydrogenii (pH) was moderate, and for other parameters varied between substantial to excellent, on comparing the results obtained by Hipee S2 with those measured by laboratory reference analysers. The semi-quantitative results of microalbumin and creatinine were highly correlated with the quantitative results. CONCLUSIONS Hipee S2 POCT urine analyser showed acceptable analytical performance as a semi-quantitative method. It serves as a convenient alternate device for clinicians and individual users for urinalysis and health management.

P4454N-terminal pro-brain natriuretic peptide and resistance to chronic therapy with 75 mg acetylsalicylic acid assessed by point-of-care test - prospective single center study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K M Cygulska ◽  
Ł Figiel ◽  
D Slawek ◽  
A Karzkowiak ◽  
M Wraga ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Secondary Prevention ◽  
Brain Natriuretic Peptide ◽  
Acetylsalicylic Acid ◽  
Natriuretic Peptide ◽  
Predictive Value ◽  
Independent Predictor ◽  
Point Of Care ◽  
Left Ventricular ◽  
Left Ventricular Ejection

Abstract Background Acetylsalicylic acid (ASA) remains the principal medication for secondary prevention of atherosclerotic complications. Resistance to ASA (ASAres) is multifactorial and results in insufficient reduction of platelet reactivity through incomplete inhibition of thromboxane A2 (TXA2) synthesis. There is controversy regarding the optimal preventive ASA dose with common daily use of 75 mg in many European countries. Purpose The aim of our study is to reassess the prevalence and predictors of ASAres in contemporary cohort of coronary disease (CAD) patients (pts) on stable therapy with 75 mg ASA. Methods We studied 205 patients (36,6% females) with stable CAD and concomitant atherosclerotic disease history (ischemic stroke 10,2%, peripheral vascular disease 8,3%,) and type 2 diabetes in 39,5% on stable regimen 75 mg ASA for a minimum of 1 month (mean age 68,2±9,7 years, mean BMI 27,3±4,7 kg/m2). ASAres was defined as ARU (aspirin reaction unit) ≥550 using point-of-care VerifyNow Aspirin test. Exclusion criteria were: recent (up to 2 months) acute coronary syndrome, cancer, dermatological disease, epilepsy or other chronic neurological diseases, exacerbation of allergic disease, rheumatoid arthritis, periodontal disease, alcoholism, drug addiction, vegetarianism, veganism and other specific diets, and known thrombophilia. The population received standard concomitant preventive treatments including RAA blockade in 88,3%, beta-blockers in 85,9%, statins in 93,2%, and proton pump inhibitors (PPI) in 65,4%. History of infarction was present in 37% and mean left ventricular ejection fraction was 47% (18–75%). Results ASAres was detected in 11,7% of patients. Modest but significant correlations (Spearman's coefficient of rank correlation rho) were detected between ARU and C-reactive protein (CRP) (rs=0,15; p=0,030), N-terminal pro-brain natriuretic peptide (NT-proBNP) (rs=0,15; p=0,039), body weight (rs=0,22; p=0,0014), BMI (rs=0,207, p=0,0029). No significant differences in ASAres we found with regard to sex, other risk factors or concomitant medication, including PPI. However, in ASAres pts median concentrations of NT-proBNP were significantly higher (median 311 vs. 646pg/ml; p=0,046). In multivariate analysis NT-proBNP emerged as the only independent predictor of ASAres (AUC=0,626; p=0,027 with threshold value of 327,3 pg/ml resulting with negative predictive value of 16,98% and positive predictive value of 93,95% for ASAres). Conclusion ASAres has significant prevalence in this secondary prevention CAD cohort treated with 75 mg daily dose. NT-proBNP was identified as the only independent predictor in multivariate analysis. This finding may be important especially for pts with heart failure of ischemic etiology. The implications of switching into 100 mg or higher ASA doses remain to be investigated. Acknowledgement/Funding study was supported from unrestricted research grant from Aflofarm SA

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