Analytical evaluation of a new point of care system for measuring cardiac Troponin I.

OBJECTIVES Point-of-care cardiac troponin testing with adequate analytical performances has the potential to improve chest pain patients flow in the emergency department. We present the analytical evaluation of the newly developed Philips Minicare cTnI point-of-care immunoassay. DESIGN & METHODS Li-heparin whole blood and plasma were used to perform analytical studies. The sample type comparison study was performed at 4 different hospitals. The 99th percentile upper reference limit (URL) study was performed using Li-heparin plasma, Li-heparin whole blood and capillary blood samples from 750 healthy adults, aging from 18 to 86years. RESULTS Limit of the blank, limit of detection and limit of quantitation at 20% coefficient of variation (CV) were determined to be 8.5ng/L, 18ng/L and 38ng/L respectively without significant differences between whole blood and plasma for LoQ. Cross-reactivity and interferences were minimal and no high-dose hook was observed. Total CV was found to be from 7.3% to 12% for cTnI concentrations between 109.6 and 6135.4ng/L. CV at the 99th percentile URL was 18.6%. The sample type comparison study between capillary blood, Li-heparin whole blood and Li-heparin plasma samples demonstrated correlation coefficients between 0.99 and 1.00 with slopes between 1.03 and 1.08. The method comparison between Minicare cTnI and Beckman Coulter Access, AccuTnI+3 demonstrated a correlation coefficient of 0.973 with a slope of 1.09. The 99th percentile URL of a healthy population was calculated to be 43ng/L with no significant difference between genders or sample types. CONCLUSIONS The Minicare cTnI assay is a sensitive and precise, clinical usable test for determination of cTnI concentration that can be used in a near-patient setting as an aid in the diagnosis of acute myocardial infarction.

[1]  J. Attia,et al.  Point of care troponin decreases time in the emergency department for patients with possible acute coronary syndrome: a randomised controlled trial , 2010, Emergency Medicine Journal.

[2]  K. Rooney,et al.  Point-of-care testing in the overcrowded emergency department – can it make a difference? , 2014, Critical Care.

[3]  D. Altman,et al.  STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT , 1986, The Lancet.

[4]  L. Lind,et al.  The applied statistical approach highly influences the 99th percentile of cardiac troponin I. , 2016, Clinical biochemistry.

[5]  Jeroen J. Bax,et al.  2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). , 2011, European heart journal.

[6]  Michael Christ,et al.  Cardiac troponin: a critical review of the case for point-of-care testing in the ED. , 2012, The American journal of emergency medicine.

[7]  L. Neyses,et al.  Kardiologische Aspekte der präoperativen Risikostratifizierung , 2011 .

[8]  F. Apple,et al.  The global need to define normality: the 99th percentile value of cardiac troponin. , 2014, Clinical chemistry.

[9]  Fred S Apple,et al.  National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes. , 2007, Circulation.

[10]  Jeroen J. Bax,et al.  ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation , 2012 .

[11]  P. Rahko.  Rapid evaluation of chest pain in the emergency department. , 2014, JAMA internal medicine.

[12]  W. D. Johnson,et al.  Use of Pearson’s Chi-Square for Testing Equality of Percentile Profiles across Multiple Populations , 2015, Open journal of statistics.

[13]  Fred S Apple,et al.  Third universal definition of myocardial infarction , 2012 .

[14]  Marco H Hefti,et al.  Rapid, high sensitivity, point-of-care test for cardiac troponin based on optomagnetic biosensor. , 2010, Clinica chimica acta; international journal of clinical chemistry.

[15]  A. Jaffe,et al.  2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. , 2014, Circulation.

[16]  J. Alpert,et al.  Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction , 2008 .

[17]  Mwj Menno Prins,et al.  Rapid integrated biosensor for multiplexed immunoassays based on actuated magnetic nanoparticles. , 2009, Lab on a chip.

[18]  W. Bablok,et al.  A New Biometrical Procedure for Testing the Equality of Measurements from Two Different Analytical Methods. Application of linear regression procedures for method comparison studies in Clinical Chemistry, Part I , 1983, Journal of clinical chemistry and clinical biochemistry. Zeitschrift fur klinische Chemie und klinische Biochemie.

[19]  J M Bland,et al.  Statistical methods for assessing agreement between two methods of clinical measurement , 1986 .

[20]  A. Jaffe,et al.  The third Universal Definition of Myocardial Infarction--moving forward. , 2012, Clinical chemistry.

[21]  F. Apple,et al.  Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction , 2015, Clinical chemistry and laboratory medicine.