Cardio Chek Plus Analyzer Accuracy and Precision Lipid

Cardio. Chek Plus Analyzer Accuracy and Precision Lipid and Glucose Testing Cardio. Chek® Plus Analyzer Lipid + e. GLUTM Test Strips Smart Bundle. TM Pack

PTS Diagnostics’ Cardio. Chek Plus® Lipid + e. GLU Test Strips Smart Bundle. TM 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’ Cardio. Chek Plus® Analyzer and Lipid + e. GLU Test Strips Smart Bundle. TM Pack Recognizing the linkage between heart attack, stroke, and diabetes, the Cardio. Chek Plus analyzer provides rapid on-site lipid panel plus glucose results to help identify atrisk individuals. Handheld and battery-powered, the Cardio. Chek 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 Cardio. Chek 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 ester + H 2 O Cholesterol + H 2 O + O 2 2 H 2 O 2 + 4 -AAP + disubstituted aniline HDL Cholesterol VLDL, HDL plasma Cholesterol ester + H 2 O Cholesterol + H 2 O + O 2 2 H 2 O 2 + 4 -AAP + disubstituted aniline Triglycerides + 3 H 2 O Glycerol + ATP Glycerol-3 -PO 4 + O 2 2 H 2 O 2 + 4 -AAP + N, N-disubstituted aniline cholesterol esterase cholesterol oxidase peroxidase lipoprotein lipase glycerol kinase glycerophosphate oxidase peroxidase Cholesterol + fatty acid Cholesterol-4 -en-one + H 2 O 2 quinoneimine dye + 4 H 2 O VLDL, depleted plasma Cholesterol + fatty acid Cholesterol-4 -en-one + H 2 O 2 quinoneimine dye + 4 H 2 O glycerol + 3 fatty acid Glycerol-3 -PO 4 + ADP Dihydroxyacetone-PO 4 + H 2 O 2 quinoneimine dye + 4 H 2 O

Principles of the e. GLU Test (Electrochemical) • The e. GLU 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 + GO x-FAD (ox) → Gluconolactone + GO x-FADH 2 (red) [above electrode] b) Kferri(ox) + GOx-FADH 2 → GOx-FAD + Kferri(red) [above electrode] c) Kferro(red) → Kferri(ox) [at electrode] 2 Fe(CN)64 - (ferro) → 2 Fe(CN)63 - (ferri) + 2 e- (detection of ferro at carbon electrode +400 m. V)

Measuring Range: PTS Panels® lipid panel test strips will provide numeric results in the following ranges: Cholesterol: 100 -400 mg/d. L (2. 59 -10. 36 mmol/L, 1 -4 g/L) HDL Cholesterol: 15 -100 mg/d. L (0. 39 -2. 59 mmol/L, 0. 15 -1 g/L) Triglycerides: 50 -500 mg/d. L (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: The electrochemical glucose test system will detect glucose levels from 40 -600 mg/d. L (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/d. L (2. 22 mmol/L, 0. 40 g/L). Results above 600 mg/d. L (33. 3 mmol/L, 6 g/L) will read “>___” (greater than measuring range).

Correlation of PTS Diagnostics’ Cardio. Chek® Plus Analyzer and Lipid + e. GLUTM Test Strips Smart Bundle. TM Pack (cholesterol) Relative to the Cobas® Integra 400 Plus Reference Method Cholesterol 350 Cardio. Chek Plus Fingerstick 300 Cardio. Chek Plus Venipuncture Cholesterol 400 250 200 150 100 50 300 250 200 150 100 50 0 100 200 Roche Cobas® Integra y = 1. 12 x – 27. 5 R- = 0. 95 n = 26 0 200 400 Roche Cobas® Integra y = 0. 93 x + 13. 5 R = 0. 91 n = 478 The linear regression data shows a strong correlation between the Cardio. Chek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ Cardio. Chek® Plus Analyzer and Lipid + e. GLUTM Test Strips Smart Bundle. TM Pack (HDL cholesterol) Relative to the Cobas® Integra 400 Plus Reference Method HDL Cholesterol 90 80 70 60 50 40 30 20 10 HDL Cholesterol 120 Cardio. Chek Plus Fingerstick CCPlus Fingerstick Cardio. Chek Plus Venipuncture CCPlus Venipuncture 100 80 60 40 20 0 0 Roche Cobas® Integra y = 1. 21 x -6. 8 R = 0. 92 n = 23 50 100 Roche Cobas® Integra y = 1. 10 x -2. 1 R = 0. 94 n = 455 The linear regression data shows a strong correlation between the Cardio. Chek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ Cardio. Chek® Plus Analyzer and Lipid + e. GLUTM Test Strips Smart Bundle. TM Pack (triglycerides) Relative to the Cobas® Integra 400 Plus Reference Method Triglycerides 450 400 250 Cardio. Chek Plus Fingerstick Cardio. Chek Plus Venipuncture 300 200 150 100 50 300 250 200 150 100 50 0 100 200 Roche Cobas® Integra 300 y = 0. 95 x -8. 8 R = 0. 99 n = 22 0 200 Roche Cobas® Integra 400 y = 1. 08 x -7. 1 R = 0. 98 n = 422 The linear regression data shows a strong correlation between the Cardio. Chek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ Cardio. Chek® Plus Analyzer and Lipid + e. GLUTM Test Strips Smart Bundle. TM Pack (e. GLU) Relative to the Cobas® Integra 400 Plus Reference Method Electrochemical Glucose 400 Cardio. Chek Plus Fingerstick 350 300 250 200 150 100 50 0 0 100 200 300 400 Roche Cobas® Integra y = 0. 873 x + 8. 668 R = 0. 95 n = 431 The linear regression data shows a strong correlation between the Cardio. Chek Plus analyzer and the reference laboratory.

Correlation of PTS Diagnostics’ Cardio. Chek® Plus Analyzer and Lipid + e. GLUTM Test Strips Smart Bundle. TM Pack Relative to the Cobas® Integra 400 Plus Reference Method Lipid Panel Total Cholesterol on CC Plus Cardio. Chek Plus 400 350 R 2 = 0. 9609 300 250 HDL on CC Plus HDL on Cardio. Chek Plus 200 R 2 = 0. 9616 150 100 Trigs on CC Plus Trigs on Cardio. Chek Plus 50 R 2 = 0. 9894 0 0 100 200 300 Roche Cobas® Integra (mg/d. L) 400 600 Cardio. Chek Plus Analyzer (mg/d. L) 450 e. GLU 500 R 2 = 0. 9931 400 300 200 100 0 0 100 200 300 400 Roche Cobas® Integra (mg/d. L) The linear regression data shows a strong correlation between the Cardio. Chek Plus analyzer and the reference laboratory. 500 600

PTS Diagnostics’ Cardio. Chek® Plus Analyzer and Lipid + e. GLU Test Strips Smart Bundle. TM Pack Precision N=50 for all levels e. Glu Test Cardio. Chek Plus analyzer Excellent precision at the low, mid and high range of the assay.

PTS Diagnostics’ Cardio. Chek Plus® Analyzer and Lipid + e. GLU Test Strips Smart Bundle. TM Pack Linearity Total Cholesterol Linearity HDL Cholesterol Linearity 140 R 2 = 0. 9833 400 350 300 250 200 150 R 2 = 0. 9968 100 50 0 0. 000 0. 200 0. 400 0. 600 0. 800 1. 000 Dilution Factor 100 Cardio. Chek Plus (mg/d. L) R 2 = 0. 9896 400 300 200 0 0. 000 R 2 = 0. 9929 0. 200 0. 400 0. 600 0. 800 Dilution Factor 60 40 1. 000 1. 200 R 2 = 0. 9991 20 700 600 100 80 0 0. 000 1. 200 Triglycerides Linearity 500 R 2 = 0. 9984 120 600 0. 200 0. 400 0. 600 0. 800 Dilution Factor 1. 000 1. 200 e. Glucose Linearity R 2 = 0. 9995 500 400 300 200 R 2 = 0. 9995 100 0 0. 000 0. 500 1. 000 Dilution Factor 1. 500 All chemistries are linear throughout the dynamic range of each assay. LIT 001716 Rev. 0 3/15 450 Cardio. Chek Plus (mg/d. L) 500