| CardioChek Technical Data |
| The following studies were conducted in the UK. |
| Analysis of the MDA Report on the LDX (1995), and MHRA on the CardioChek (2005) and the CEP Report on Lipid Analysers (2009). Sensitivity and Specificity of the Total Cholesterol / HDL Cholesterol classification of Lipid Results |
| |
|
Sensitivity |
Specificity |
| Result |
CardioChek |
LDX |
CardioChek |
LDX |
TC/HDL Ratio > 5.0
|
90% |
80% |
74% |
99% |
| Total Cholesterol >= 5.2 and/or TC/HDL Ratio > 5.0 |
98% |
94% |
55% |
89% |
| Total Cholesterol >= 6.5 and TC/HDL Ratio > 5.0 |
93% |
80% |
85% |
98% |
|
| Conclusion |
The CardioChek system is more accurate in placing patients into CVD risk categories when the CHO/HDL ratio is used than the LDX system.
The table below summarizes the features and benefits of the CardioChek PA when compared to the Cholestech LDX. The remainder of this document will then summarize several investigation reports compiled on both instruments to provide an in-depth technical and operational comparison for both point-of-care instruments. Feature comparison colour coding is used as below. |
| |
CardioCheck PA v Cholestech LDX |
 |
Category Winner |
 |
Both Instruments Comparable |
 |
Beaten in Category |
|
| Category |
CardiChek PA |
Cholestech LDX |
| Technology |
Reflectance |
Reflectance |
| CRMLN certified |
Yes |
Yes |
| test menu |
Panels: |
Panels: |
|
 |
Lipid=CHO/HDL/TRIG/Calc HDL and Calc CHO/HDL ratio |
|
CHO/HDL and Calc CHO/HDL ratio |
|
HDL/Trig/Glucose and calc CHO/HDL ratio |
| |
|
| Single: |
|
Total Cholestrol |
|
HDL-Cholestrol |
|
Triglyceride |
|
Glucose |
|
Ketones |
|
Creatinine |
|
Direct LDL |
|
|
Lipid |
|
Lipid & GLU |
|
CHO/HDL |
|
CHO/HDL/GLU |
|
ALT/AST |
| |
|
| Single: |
|
hs-CRP |
|
| List Price |
£479 |
£1,250 without printer |
| Reagent Price |
Dual Test Strips(25cnt): £106.37 = £4.26 per test
Triple Panel Strips(15cnt):£ 67.20 = £4.48 per test |
Dual Test Cassettes(10cnt): £76.45= £7.65 per test
Triple Panel Cassettes(10cnt): £85.0 =£8.50 per test |
| Reagent Storage |
Room Temperature |
Room Temperature for 30 days 2-8°C up to expiration date |
Analytical Measureable Range:
Total Cholestrol
HDL Cholestrol
Triglycerides
Direct LDL
Units = mmol/L |
2.59-10.36
0.39-2.59
0.56-5.65
1.30-5.18- |
2.58-12.52
0.39-2.59
0.51-7.34
Test not available on LDX |
| Lot Specific Calibration |
Lot Specific MEMo chip supplied with test strips |
Encoded on cassette magnetc strip |
| Sample type |
Capillary or venous whole blood |
Capillary or venous whole blood plasma or serum |
| Sample Voulme |
15-40 microliters |
35 microliters |
| Measurement time |
2 minutes or less
*average lipid panel time:1.31 minutes |
5 minutes or greater
*average lipid panel time: 5.27minutes |
| Heamatocrit Range |
30-45 |
up to 52 |
| Memory |
200 results= 30 per analyte for both patient and control values |
Last result only |
| Operating Temperature |
18-35°C |
20-30° C |
| Power supply |
2 x 1.5v AAA betteries |
9v Power cord for main adapter(does not operate on battery power) |
| Weight |
122g |
1kg |
|
| |
Clinical Decision Points
Introduction
The following information and tables were compiled from the September 2009 NHS CEP Buyer’s Guide, the 2005 MHRA Report on the CardioChek system and the 1995 MHRA report on the LDX system. The below clinical decision tables are calculated by using the linear regression statistics obtained by the 2009 NHS CEP Buyer’s Guide and 1995/2005 MHRA Reports, where the formula y=mx+b is used to establish an overall relationship between (X)- the reference lab and (Y)- the point of care instrument. From this comparison equation a slope and intercept is obtained, each of these statistical values are used to then accurately predict what the point-of-care instrument result will be at an analyte value that relates to clinical decision’s when assessing an individuals Cardiac Risk Factor. Below is an example of how the formula is used to predict clinical values:
Point-of-Care Predicted Value= Slope (clinical decision value) + Intercept |
2009 NHS Buyers Guide Clinical Decision Points |
Cholesterol
CardioChek PA Linear Regression: Y= 0.72x + 1.76
Cholestech LDX Linear Regression: Y= 0.95x + 0.11
|
| Clinical Decision Point : Cholesterol |
CardioChek PA Value |
Cholestech LDX Value |
| 4.1 mmol/L |
4.71 |
4.01 |
| 5.2 mmol/L |
5.40 |
5.05 |
| 6.2 mmol/L |
6.22 |
6.00 |
| 7.2 mmol/L |
7.00 |
6.95 |
|
| |
HDL Cholesterol
CardioChek PA Linear Regression: Y= 1.02x + -0.06
Cholestech LDX Linear Regression: Y= 0.93x + 0.16 |
| Clinical Decision Point : Cholesterol |
CardioChek PA Value |
Cholestech LDX Value |
| 1.04 mmol/L |
1.12 |
1.13 |
| 1.55 mmol/L |
1.52 |
1.60 |
| 2.07 mmol/L |
2.05 |
2.09 |
| 2.59 mmol/L |
2.58 |
2.57 |
|
|
2005 CardioChek PA MHRA Evaluation Report 05051 |
Cholesterol
CardioChek PA Linear Regression: Y= 0.76x + 1.52 |
| Clinical Decision Point: Cholesterol |
CardioChek PA Value |
4.1 mmol/L |
4.64 |
5.2 mmol/L |
5.47 |
6.2 mmol/L |
6.23 |
7.2 mmol/L |
7.00 |
|
| |
HDL Cholesterol
CardioChek PA Linear Regression: Y= 1.02x + -0.06 |
| Clinical Decision Point: Cholesterol |
CardioChek PA Value |
1.04 mmol/L |
1.13 |
1.55 mmol/L |
1.60 |
2.07 mmol/L |
2.09 |
2.59 mmol/L |
2.57 |
|
|
1995 Cholestech LDX MDA Evaluation Report: MDA/95/23 |
Cholesterol
Cholestech LDX Linear Regression: Y= 0.95x + 0.11 |
| Clinical Decision Point: Cholesterol |
Cholestech LDX Value |
4.1 mmol/L |
4.01 |
5.2 mmol/L |
5.05 |
6.2 mmol/L |
6.00 |
7.2 mmol/L |
6.95 |
|
| |
HDL Cholesterol
Cholestech LDX Linear Regression: Y= 0.93x + 0.16 |
| Clinical Decision Point: Cholesterol |
Cholestech LDX Value |
1.04 mmol/L |
1.00 |
1.55 mmol/L |
1.52 |
2.07 mmol/L |
2.05 |
2.59 mmol/L |
2.58 |
|
|
Summary |
It is evident that based upon the information in the above tables that both the CardioChek PA and Cholestech LDX are both suitable point-of-care instruments for cardiac risk screening. This is based upon both instruments accurately placing individuals based upon clinical decision points relative to cardiac risk assessment and further clinical follow-up. As a result of both instruments accurately placing individuals with and without risk it is important to consider overall benefits based on platform capabilities and specifications. Some various capabilities to keep in mind when determining which point-of-care cholesterol measuring device is right for you are as follows: |
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Overall price for both instrument and reagents |
|
Ease of use |
|
Portability |
|
Size of test menu |
|
Power source |
|
Test completion time |
|
Reagent storage |
|
Sample size and source |
|
Overall weight if shipping to various locations for testing |
|
| |
Once one has compared the specifications of each point-of-care instrument an educated and technically sound decision can be made as to which device best suits their application.
References:
NHS CEP Buyers Guide: Point-of-Care testing for cholesterol measurement, CEP 09020
MHRA Report 05051 2005: Polymer Technology Systems CardioChek PA Lipid System
MDA Evaluation Report 1995: Cholestech LDX Lipid Analyzer, MDA/95/23 |
CardioChek PA Technical Specification |
| Technical Specification |
Measuring theory |
Reflectance photometry |
Test range |
Cholestrol: 2.59- 10.36mmol/L, hdl:0.39-2.59mmol/L, ldl:1.29-5.18mmol/L, triglycerides: 0.57-5.65mmol/L, glucose: 1.11-3.33mmol/L |
measuring temperature |
18-35°C |
measuring method |
spectrophotometry |
| measuring time |
1.6 minutes (full lipid), 45 seconds (glucose) |
| sample |
whole blood. 15-40µl |
|
|
CardioCheck Technical Data Sheet
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