glucose and lipid testing using the pts diagnostics ... · ˛pts diagnostics, indianapolis, in,...

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 pro� les are important in cardiovascular disease (CVD) risk assessment, diagnosis, and treat-ment. Additionally, patients a� ected 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.

PURPOSEThe 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 e� ort to facilitate real-time CPRD.

METHODSBlood 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 di� erence to assess bias according to ISO 15197:2013 guidelines for glu and CAP guidelines for tChol, HDL, and trig. Clinical risk strati� cation was assessed using risk category cut points of glu, tChol, HDL, and trig to determine if di� erences resulted in a 0, 1, or 2 category change. Fisher’s Exact test was used to assess di� erences 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

CONCLUSIONPTS 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 strati� cation revealed no statistical di� erences between capillary samples analyzed on the CardioChek Plus analyzer and venous blood tested on clinical laboratory analyzers. The CardioChek Plus analyzer o� ers 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.

1PTS Diagnostics, Indianapolis, IN, 2Orriant, Sandy, UT, 3St. Luke’s Hospital, Chester� eld, MO, 4UNC Lenoir Health Care, Kinston, NC, 5Springs 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 AnalyzerClinical Lab Analyzers

RESULT SUMMARY TABLE

AVERAGE BIAS -0.33% -1.02%

LINEAR REGRESSIONGlucose 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 Analyzers0.62%-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 AnalyzersCardioChek Plus AnalyzerClinical Lab AnalyzersCardioChek Plus AnalyzerClinical Lab AnalyzersClinical Lab Analyzers CardioChek Plus Clinical Lab AnalyzersCardioChek PlusClinical Lab AnalyzersCardioChek PlusClinical Lab AnalyzersCardioChek Plus Analyzer Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab AnalyzersCardioChek Plus AnalyzerClinical Lab AnalyzersCardioChek Plus AnalyzerClinical Lab Analyzers

SLOPEINTERCEPT

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 AnalyzersClinical Lab Analyzers

0.5052

Glucose< 100, 100-125, ≥ 126 mg/dL

0.6079 0.1573 > 0.9999

< 200, 200-239, ≥ 240 mg/dLCardioChek Plus Analyzer Clinical Lab Analyzers CardioChek Plus Analyzer Clinical Lab Analyzers

< 40, 40-59, ≥ 60 mg/dLCardioChek Plus AnalyzerCardioChek Plus Analyzer

CLINICAL RISK STRATIFICATION

0.881 0.98711.196 0.3770.983 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 -0.3261.049 1.087

-7.657

Clinical Lab AnalyzersCardioChek Plus AnalyzerClinical Lab AnalyzersCardioChek Plus AnalyzerClinical Lab AnalyzersCardioChek Plus AnalyzerClinical Lab AnalyzersCardioChek Plus Analyzer

0 20 40 60 80

010203040

-10-20-30-40

500 100 200 300 400150 250 350

Roche Cobas Integra 400 Plus Risk Category

Agree1 Category Di� p value > 0.9999

Triglycerides Clinical RiskTriglycerides Bias Plot

Roche Cobas Integra 400 Plus Triglycerides (mg/dL)

Trig

lyce

ride

s (m

g/dL

)


CAP 25% Bias Guideline

Triglycerides Linear Regression


Trig

lyce

ride

s (m

g/dL

)

CardioChek Plus Analyzer y = 1.049x - 0.326Clinical Lab Analyzers y = 1.087x - 7.657

Clinical Lab Analyzers


0 100 200 300 4000

100

200

300

400

r

0 20 40 60 80

010203040

-10-20-30-40

50 100 200 300 400150 250 3500 100 200 300 4000

100

200

300

400


Agree1 Category Di� p value 0.6079

Cholesterol Clinical Risk



Cholesterol Bias Plot

Roche Cobas Integra 400 Plus Cholesterol (mg/dL)

Chol

este

rol (

mg/

dL)



Cholesterol Linear Regression


Chol

este

rol (

mg/

dL)


TOTAL CHOLESTEROL

HDL CHOLESTEROL

TRIGLYCERIDES

GLUCOSE

0 20 40 60 80

010203040

-10-20-30-40

20 60 100 12040 800 20 40 60 80 100 1200

20

40

60

80

100

120



HDL Cholesterol Clinical RiskHDL Cholesterol Bias Plot

Roche Cobas Integra 400 Plus HDL Cholesterol (mg/dL)

HD

L Ch

oles

tero

l (m

g/dL

)



HDL Cholesterol Linear Regression


HD

L Ch

oles

tero

l (m

g/dL

)

CardioChek Plus Analyzer y = 0.923x + 1.685Clinical Lab Analyzers y = 0.860x + 4.121



0 20 40 60 80

010203040

-10-20-30-40

500 100 200 300 400150 250 350


Agree1 Category Di� p value > 0.9999

Triglycerides Clinical RiskTriglycerides Bias Plot


Trig

lyce

ride

s (m

g/dL

)



Triglycerides Linear Regression


Trig

lyce

ride

s (m

g/dL

)




0 100 200 300 4000

100

200

300

400

r

0 20 40 60 80

010203040

-10-20-30-40

0 100 200 300 400 5000 100 200 300 400 5000

100

200

300

400

500



Glucose Clinical RiskGlucose Bias Plot

Roche Cobas Integra 400 Plus Glucose (mg/dL)

Glu

cose

(mg/

dL)


ISO 15197:2013 Guideline

Glucose Linear Regression


Glu

cose

(mg/

dL)




0 20 40 60 80

010203040

-10-20-30-40

20 60 100 12040 800 20 40 60 80 100 1200

20

40

60

80

100

120



HDL Cholesterol Clinical RiskHDL Cholesterol Bias Plot


HD

L Ch

oles

tero

l (m

g/dL

)



HDL Cholesterol Linear Regression


HD

L Ch

oles

tero

l (m

g/dL

)




0 20 40 60 80

010203040

-10-20-30-40

50 100 200 300 400150 250 3500 100 200 300 4000

100

200

300

400



Cholesterol Clinical Risk



Cholesterol Bias Plot


Chol

este

rol (

mg/

dL)



Cholesterol Linear Regression


Chol

este

rol (

mg/

dL)


0 20 40 60 80

010203040

-10-20-30-40

0 100 200 300 400 5000 100 200 300 400 5000

100

200

300

400

500



Glucose Clinical RiskGlucose Bias Plot


Glu

cose

(mg/

dL)


ISO 15197:2013 Guideline

Glucose Linear Regression


Glu

cose

(mg/

dL)




glucose and lipid testing using the pts diagnostics ... · ˛pts diagnostics, indianapolis, in,...

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