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.  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:
HDL 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: - 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  |
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