Carrie Jo Szablowski, MLS(ASCP)1; Emily Suscha1; Corina Lindke1; Maria Shafai, MT(ASCP)1; Patrice Richter2; Michele Steinhouse, BSN3; Kristen Hanchey, MLS(ASCP)4; Deborah Mullis, MT(ASCP)5; April Mathis5; Karmen Mercer1; Keith A. Moskowitz, PhD1; James H. Anderson, MD1 Blood lipid profiles are important in cardiovascular disease (CVD) risk assessment, diagnosis, and treat- ment. Additionally, patients affected by diabetes show an increased risk for CVD. The American College of Cardiology and the American Heart Association have cooperatively published guidelines in assessing CVD risk while encouraging clinician- patient risk discussion (CPRD) to engage patients in their own CVD risk reduction and management. This shared decision-making allows for more personalized interactions and empowers the patient to continue positive lifestyle changes or make a fully informed decision in beginning statin therapy. PURPOSE The purpose of this study was to assess the performance of the PTS Diagnostics CardioChek Plus analyzer and PTS Panels® Smart Bundle at the point of care for measuring glucose (glu), total cholesterol (tChol), high-density lipoprotein (HDL), and triglycerides (trig) in an effort to facilitate real- time CPRD. METHODS Blood from 76 subjects was collected and analyzed at four facilities across the United States. Capillary blood was tested on the PTS Diagnostics CardioChek Plus analyzer using the Smart Bundle test strips, while venous blood was tested on the Beckman Coulter AU5400, UniCel® DxC 660i, Ortho VITROS® 4600, and Abbott Architect as the clinical laboratory analyzer comparators and Roche Cobas® Integra 400 Plus as the reference. Data analysis included correlation regression analysis to determine accuracy and percent difference to assess bias according to ISO 15197:2013 guidelines for glu and CAP guidelines for tChol, HDL, and trig. Clinical risk stratification was assessed using risk category cut points of glu, tChol, HDL, and trig to determine if differences resulted in a 0, 1, or 2 category change. Fisher’s Exact test was used to assess differences amongst methods. The Consensus Error Grid is used as a means of interpreting laboratory glucose values as they relate to therapeutic decisions. Zone A is defined as no effect on clinical action and Zone B is defined as altered clinical action with little to no effect on clinical outcome, while Zones C – E define altered clinical outcome CardioChek is a trademark of Polymer Technology Systems, Inc. All other product names are the property of their respective owners. © 2017 Polymer Technology Systems, Inc. LIT 001882 Rev. 1 10/17 CONCLUSION PTS Diagnostics CardioChek Plus analyzer and PTS Panels Smart Bundle lipid and glucose results were shown to be as accurate as clinical laboratory analyzers and within CAP and ISO guidelines for bias. Lipid analytes showed linear correlations equivalent with the clinical laboratory analyzers. Risk stratification revealed no statistical differences between capillary samples analyzed on the CardioChek Plus analyzer and venous blood tested on clinical laboratory analyzers. The CardioChek Plus analyzer offers accurate lipid and glucose results immediately at the point–of-care, thereby allowing clinicians real-time education and encouragement to patients managing diabetes and cardio- vascular disease. The accuracy, small sample size, and quick turnaround time make the CardioChek Plus analyzer a valuable tool for clinicians to engage patients in shared decision- making of their own healthcare. 1 PTS Diagnostics, Indianapolis, IN, 2 Orriant, Sandy, UT, 3 St. Luke’s Hospital, Chesterfield, MO, 4 UNC Lenoir Health Care, Kinston, NC, 5 Springs Memorial Hospital, Lancaster, SC Glucose and Lipid Testing Using the PTS Diagnostics CardioChek® Plus Analyzer: A Point-Of-Care Tool to Engage Patients in Clinician-Patient Risk Discussions and Encourage Healthy Lifestyles BACKGROUND CardioChek Plus Analyzer Clinical Lab Analyzers RESULT SUMMARY TABLE AVERAGE BIAS -0.33% -1.02% LINEAR REGRESSION Glucose Total Cholesterol HDL Cholesterol Triglycerides ACCURACY 2013 ISO Guideline < 100 mg/dL ± 15 mg/dL ≥ 100 mg/dL ± 15% Glucose CardioChek Plus Analyzer Clinical Lab Analyzers 0.62% -2.18% -1.74% -4.67% -5.68% 5.65% CardioChek Plus Analyzer Triglycerides CAP Guideline ± 10% CAP Guideline ± 30% CAP Guideline ± 25% Total Cholesterol HDL Cholesterol Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab Analyzers Clinical Lab Analyzers Clinical Lab Analyzers SLOPE INTERCEPT R AGREE 62 82% 66 87% 66 87% 69 91% 62 82% 69 91% 72 95% 73 96% 1 CATEGORY 14 18% 10 13% 10 13% 7 9% 14 18% 7 9% 4 5% 3 4% 2 CATEGORY 0 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 0% p value Clinical Lab Analyzers Clinical Lab Analyzers 0.5052 Glucose < 100, 100-125, ≥ 126 mg/dL 0.6079 0.1573 > 0.9999 < 200, 200-239, ≥ 240 mg/dL CardioChek Plus Analyzer Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab Analyzers < 40, 40-59, ≥ 60 mg/dL CardioChek Plus Analyzer CardioChek Plus Analyzer CLINICAL RISK STRATIFICATION 0.881 0.987 11.196 0.377 0.983 0.990 0.990 < 150, 150-199, ≥ 200 mg/dL 1.009 1.048 0.923 0.860 -5.643 -12.045 HDL Cholesterol Triglycerides 0.953 0.964 0.936 0.955 0.979 Total Cholesterol 1.685 4.121 -0.326 1.049 1.087 -7.657 Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab Analyzers CardioChek Plus Analyzer 0 10 20 30 40 -10 -20 -30 -40 50 0 100 200 300 400 150 250 350 Triglycerides Bias Plot Roche Cobas Integra 400 Plus Triglycerides (mg/dL) Triglycerides (mg/dL) CardioChek Plus Analyzer Clinical Lab Analyzers CAP 25% Bias Guideline r 0 10 20 30 40 -10 -20 -30 -40 50 100 200 300 400 150 250 350 Cholesterol Bias Plot Roche Cobas Integra 400 Plus Cholesterol (mg/dL) Cholesterol (mg/dL) CardioChek Plus Analyzer Clinical Lab Analyzers CAP 10% Bias Guideline TOTAL CHOLESTEROL HDL CHOLESTEROL TRIGLYCERIDES GLUCOSE 0 20 40 60 80 100 120 0 20 40 60 80 100 120 HDL Cholesterol Linear Regression Roche Cobas Integra 400 Plus HDL Cholesterol (mg/dL) HDL Cholesterol (mg/dL) CardioChek Plus Analyzer y = 0.923x + 1.685 Clinical Lab Analyzers y = 0.860x + 4.121 Triglycerides Linear Regression Roche Cobas Integra 400 Plus Triglycerides (mg/dL) Triglycerides (mg/dL) CardioChek Plus Analyzer y = 1.049x - 0.326 Clinical Lab Analyzers y = 1.087x - 7.657 0 100 200 300 400 0 100 200 300 400 0 100 200 300 400 500 0 100 200 300 400 500 Glucose Linear Regression Roche Cobas Integra 400 Plus Glucose (mg/dL) Glucose (mg/dL) CardioChek Plus Analyzer y = 0.881x + 11.196 Clinical Lab Analyzers y = 0.987x + 0.377 0 10 20 30 40 -10 -20 -30 -40 20 60 100 120 40 80 HDL Cholesterol Bias Plot Roche Cobas Integra 400 Plus HDL Cholesterol (mg/dL) HDL Cholesterol (mg/dL) CardioChek Plus Analyzer Clinical Lab Analyzers CAP 30% Bias Guideline n 0 100 200 300 400 0 100 200 300 400 Cholesterol Linear Regression Roche Cobas Integra 400 Plus Cholesterol (mg/dL) Cholesterol (mg/dL) CardioChek Plus Analyzer y = 1.009x - 5.643 Clinical Lab Analyzers y = 1.048x - 12.045 0 10 20 30 40 -10 -20 -30 -40 0 100 200 300 400 500 Glucose Bias Plot Roche Cobas Integra 400 Plus Glucose (mg/dL) Glucose (mg/dL) CardioChek Plus Analyzer Clinical Lab Analyzers ISO 15197:2013 Guideline