Why do we need SD LipidoCare?

Transcription

1 SD Biosensor, Inc. Innovative Global Leader of In Vitro Diagnostics Total supplier of Blood Glucose Monitoring System and Lipid Analyzer System in vitro diagnostics test kits for Point of Care Testing with the highest quality standards.

2 Why do we need SD LipidoCare?

3 Market Situation Well-made Perform well Accurate High-cost Centralization

4 Imagine a system Emergency Situation

5 Imagine a system far from the hospital

6 Imagine a system at home

7 Imagine a system typical clinical lab.

8 Can be used in anyplace

9 Curious about SD LipidoCare?

10 Lipid/Cholesterol Analyzer System with Glucose test 7 test results with one drop of blood Portable size for testing Anytime & Anywhere Convenient Storage Condition: RT

11 Feature of Analyzer

12 Feature of Test Strip Lipid profile (Measured TC, TG, HDL and Calculated LDL, LDL/HDL, non-hdl) TC HDL (TC, HDL, non-hdl) TC TG HDL GLU TG TC Lipid Profile TC HDL HDL

13 Principle of Test Reflectance Photometry Detector captures the reflected light, converts it to an electronic signal, and translates that signal to its corresponding lipid concentration. - Becoming Darker Color means High Lipid - Becoming Lighter Color means Low Lipid

14 Principle of Test Single : 10 μl Profile : 35 μl after3 min

15 Principle of Test

16 SD LMS Lipid Management Software Program Portable Paper - Normal Thermal Paper - Label Type Also! LMS Test Report by PC Connection

17 SD LMS Heart Age This risk assessment tool uses a scoring system from a study know as the Framingham Heart Study to assess your risk of heart attack or dying of coronary heart disease in the next 10 years. It uses national guidelines known as the ATP III guidelines for assessing metabolic syndrome

18 Specification Method Lipid : Photometry Glucose : Electrochemical Calibration Code chip Measurement - Lipid Profile (Total cholesterol, Triglycerides, HDL, Calculated LDL, LDL/HDL, non-hdl) - Total Cholesterol - HDL Cholesterol Sample volume Sample Type Size Single 10 μl Multi: 35 μl Finger stick Venous- WB/Serum/Plasma (EDTA or heparin) Handheld (6.7 x 13cm) - Triglycerides - TC HDL Cholesterol Test time Glucose (5 seconds) Cholesterol (3 minutes) Measuring range - Glucose (electrochemical) TC : 100 ~ 450 mg/dl HDL : 25 ~ 95 mg/dl TG : 45 ~ 650 mg/dl Calculated LDL, LDL/HDL, non-hdl Glucose : 20 ~ 600 mg/dl Operating temperature range HCT Unit Convert Strip storage Temp. Shelf-life 18 ~ 32 C TC : 30 ~ 55 % TG : 30 ~ 55 % HDL: 30 ~ 52 % Lipid Profile: 30 ~ 52 % Yes (mg/dl - mmol/l) 2 ~ 32 C 18 months Strip Package Individual Pouch

19 Test Procedure With Capillary Tubes Step 1 Insert Code Chip match with test strip Step 2 Insert test strip into the instrument Step 3 Obtain a blood sample from a fingerstick and despense the blood Into sample well Step 4 Results in 3 minutes!

20 Evaluation Performance

21 Accuracy vs. Precision The accuracy of a measurement system is the degree of closeness of measurements of a quantity to its actual (true, reference) value. ` BIAS : Correlation Factor Evaluation factor system accuracy between reference and LipidoCare ACCURACY

22 Accuracy vs. Precision The precision of a measurement system, also called reproducibility or repeatability, is the degree to which repeated measurements under unchanged conditions show the same results. ` CV(%) : Coefficient Variation Evaluation factor of precision, Reproducibility, Repeatability PRECISION

23 Evaluation Performance 1. Overview : organized by SD Biosensor in K hospital, April ) Instrument Model Lot Qty. SD LipidoCare S3-M01~S3-M16 16 ea Cholestech AA ea CardioChek ea Hitachi 7020 Reference Machine 2) Strip Model Parameter Lot SD LipidoCare TC TG HDL Lipid Profile TTCP TTGP THDP TMSP Cholestech Lipid Profile Glu C CardioChek TC TG HDL Lipid Profile C019 E006 H007 P028

24 % Bias Accuracy (% Bias) Reference: Hitachi LipidoCare LDX CardioChek TC TG HDL

25 % CV Repeatability (% CV) LipidoCare LDX 6.0 CardioChek TC TG HDL

26 Certification

27 CE, TCF & ISO13485

28 Comparison Chart

29 Competitors CardioChek PTS Accutrend Plus Roche LDX Cholestech

30 LDX vs. SD LipidoCare Refrigerator Power System Test Time: 5 min. Room Temp. Condition Portable Battery Only 3 min.

31 Accutrend vs. SD LipidoCare Only GLU, TG, TC Easy to contaminate Inconvenient Lipid: 6 Glucose: 1 Individual Pouch Tech. structure Label type report

32 CardioChek vs. SD LipidoCare Sensitive with sunlight Package Less-accuracy Able to open & close Individual Pouch Tech. structure Best Accuracy

33 Advantages comparing with competitor Not portable Non multi-test Less accurate

34 Q&A Demonstration

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