CardioChek Plus Analyzer Accuracy and Precision Lipid and Glucose Testing CardioChek® Plus Analyzer Lipid + eGLUTM Test Strips Smart BundleTM Pack

PTS Diagnostics’ CardioChek Plus® Lipid + eGLU Test Strips Smart BundleTM Pack Analyzer here Portable – use in multiple exam rooms Battery operated Results in as little as 90 seconds Only requires a small drop and 40 μL of blood from finger stick Easy to use – minimal training required Reimbursable Low maintenance

PTS Diagnostics’ CardioChek Plus® Analyzer and Lipid + eGLU Test Strips Smart BundleTM Pack Recognizing the linkage between heart attack, stroke, and diabetes, the CardioChek Plus analyzer provides rapid on-site lipid panel plus glucose results to help identify at-risk individuals. Handheld and battery-powered, the CardioChek Plus analyzer requires a small blood sample from a simple fingerstick. The capability to deliver both results in as little as 90 seconds enables healthcare professionals to improve their throughput, which is particularly important in today’s health promotion environment. The CardioChek family includes products for both professional and home use and is available in many global markets.

Principles of the Lipid Test (Reflectance) Test results are based on readings of light reflected off a test strip that has changed color after blood is applied. The intensity of the color is proportional to the concentrations of cholesterol, HDL cholesterol, and triglycerides in the sample. The analyzer converts these reflectance photometry readings into cholesterol, HDL cholesterol, and triglycerides results and displays them. The enzymatic reactions that occur are listed below. Cholesterol Cholesterol ester + H2O cholesterol esterase Cholesterol + fatty acid Cholesterol + H2O + O2 cholesterol oxidase Cholesterol-4-en-one + H2O2 2H2O2 + 4-AAP + disubstituted aniline peroxidase quinoneimine dye + 4H2O HDL Cholesterol VLDL, LDL, HDL plasma VLDL, LDL, depleted plasma   Triglycerides Triglycerides + 3H2O lipoprotein lipase glycerol + 3 fatty acid Glycerol + ATP glycerol kinase Glycerol-3-PO4 + ADP Glycerol-3-PO4 + O2 glycerophosphate oxidase Dihydroxyacetone-PO4 + H2O2 2H2O2 + 4-AAP + N,N-disubstituted aniline peroxidase quinoneimine dye + 4H2O

Principles of the eGLU Test (Electrochemical) The eGLU test strips use electrochemical (amperometric) technology to produce a glucose result. When blood is applied to the test strip, the blood starts a chemical reaction that produces an electrical current. The current is converted into a glucose result and is displayed on the analyzer screen. The enzymatic reaction that occurs is listed below. Glucose a) Glucose + GOx-FAD (ox) → Gluconolactone + GOx-FADH2 (red) [above electrode] b) Kferri(ox) + GOx-FADH2 → GOx-FAD + Kferri(red) [above electrode] c) Kferro(red) → Kferri(ox) [at electrode] 2Fe(CN)64- (ferro) → 2Fe(CN)63- (ferri) + 2e- (detection of ferro at carbon electrode +400mV)  

Measuring Range Measuring Range: PTS Panels® lipid panel test strips will provide numeric results in the following ranges: Cholesterol: 100-400 mg/dL (2.59-10.36 mmol/L, 1-4 g/L) HDL Cholesterol: 15-100 mg/dL (0.39-2.59 mmol/L, 0.15-1 g/L) Triglycerides: 50-500 mg/dL (0.57-5.65 mmol/L, 0.50-5 g/L) Results below the test ranges will read “<___” (less than measuring range). Results above these ranges will read “>___” (greater than measuring range).  

Measuring Range Measuring Range: The electrochemical glucose test system will detect glucose levels from 40-600 mg/dL (2.22-33.3 mmol/L, 0.40-6 g/L) and will display a number value for results in this range. If the display reads “<___” (less than measuring range), the glucose level is below 40 mg/dL (2.22 mmol/L, 0.40 g/L). Results above 600 mg/dL (33.3 mmol/L, 6 g/L) will read “>___” (greater than measuring range).  

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (cholesterol) Relative to the Cobas® Integra 400 Plus Reference Method y = 0.93x + 13.5 R = 0.91 n = 478 y = 1.12x – 27.5 R- = 0.95 n = 26 The linear regression data shows a strong correlation between the CardioChek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (HDL cholesterol) Relative to the Cobas® Integra 400 Plus Reference Method CardioChek Plus Fingerstick CardioChek Plus Venipuncture y = 1.10x -2.1 R = 0.94 n = 455 y = 1.21x -6.8 R = 0.92 n = 23 The linear regression data shows a strong correlation between the CardioChek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (triglycerides) Relative to the Cobas® Integra 400 Plus Reference Method y = 0.95x -8.8 R = 0.99 n = 22 y = 1.08x -7.1 R = 0.98 n = 422 The linear regression data shows a strong correlation between the CardioChek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (eGLU) Relative to the Cobas® Integra 400 Plus Reference Method y = 0.873x + 8.668 R = 0.95 n = 431 The linear regression data shows a strong correlation between the CardioChek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack Relative to the Cobas® Integra 400 Plus Reference Method Total Cholesterol on CardioChek Plus HDL on CardioChek Plus Trigs on CardioChek Plus The linear regression data shows a strong correlation between the CardioChek Plus analyzer and the reference laboratory.

CardioChek Plus analyzer PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLU Test Strips Smart BundleTM Pack Precision eGlu Test CardioChek Plus analyzer N=50 for all levels Excellent precision at the low, mid and high range of the assay.

All chemistries are linear throughout the dynamic range of each assay. PTS Diagnostics’ CardioChek Plus® Analyzer and Lipid + eGLU Test Strips Smart BundleTM Pack Linearity LIT001716 Rev. 0 3/15 All chemistries are linear throughout the dynamic range of each assay.