Cardiocheck

Why a Cardiocheck?

“Because high cholesterol is responsible for more than half of the annual 125,000 deaths from coronary heart disease in the UK, yet only 14% of adults are aware that cholesterol is a risk factor.

In just two minutes you can track cholesterol levels. Be sure with the CardioChek PA Blood Analyser. The World’s first portable direct LDL cholesterol test.

The higher the blood cholesterol level, the greater the risk for developing heart disease or heart attack. The CardioChek® PA Blood Analyser is the first and only system that provides personal, at-home or point-of-care testing of total cholesterol, HDL cholesterol and triglycerides.

Multi-panel Tests

LIPID PANEL – Total Cholesterol, HDL Cholesterol, Triglycerides, LDL Cholesterol (calculated)
METABOLIC CHEMISTRY PANEL – HDL Cholesterol, Triglycerides, Glucose CVD PANEL – Total Cholesterol, HDL Cholesterol, Glucose
GENERAL SCREENING PANEL – Total Cholesterol, HDL Cholesterol

All of the above are available as single test panels too!

See the complete Cardiochek Panel Test Range here

Includes:
1 x CardioChek Blood Analyser
1 x CardioChek Check Strip

Product Description

Why CardioChek

• Innovative – Runs on portable hand-held device
• Fast – Results in one to two minutes
• Flexible – Suitable for multiple clinical applications
• Accurate – CE marked / FDA cleared / CLIA waived
• Convenient – Test at point-of-care, no fasting, no refrigeration
• Cost-effective – No expensive lab analysis or follow-up consultation delay
• Fully automated – Simply pipette a single sample onto test strip
• Memory log – Stores up to 200 results – date and time stamped

Remember that high cholesterol itself does not have symptoms, so unless you test, you won’t know if your cholesterol levels are too high. Frequent testing doesn’t have to mean frequent doctor’s appointments. Using the CardioChek® PA Analyser and test strips can help you stay on track between doctor appointments. It’s like using a scale when you are trying to lose weight.

Why Wait and Worry?

Checking your numbers gives you peace of mind, helps you make informed decisions, and lets you know if your heart health regimen is working.

Recommended cholesterol levels

• Total Cholesterol should be less than 5.2mmol/L
• HDL Cholesterol should be greater than 1 in men and 1.2mmol/L in women
• Triglyceride is best done on a fasting sample and should be less than 1.7mmol/L
• Glucose should be greater than 4 but less than 7 in a fasting sample, and less than or equal to 9mmol/L 2 hours after a meal

Know Your Cholesterol

Remember that high cholesterol itself does not have symptoms, so unless you test, you won’t know if your cholesterol levels are too high. Frequent testing doesn’t have to mean frequent doctor’s appointments. Using the CardioChek® PA Analyser and test strips can help you stay on track between doctor appointments. It’s like using a scale when you are trying to lose weight.

Why Wait and Worry?

Checking your numbers gives you peace of mind, helps you make informed decisions, and lets you know if your heart health regimen is working.

Cholesterol Definitions

Total Cholesterol

Your total cholesterol level is the sum of all the types of cholesterol in yoour blood. The higher your total cholesterol, the greater yoour risk for heart disease. A total cholesterol level of under 5.18 mmol/L (200 mg/dL) is desirable.

HDL (Good) Cholesterol

HDL cholesterol is known as “good” cholesterol because high levels of HDL can protect against heart attack. Medical experts believe that HDL carries cholesterol away from the arteries and removes excess cholesterol from arterial plaque, slowing its buildup. Levels greater than, or equal to, 1.04mmol/L in men and 1.20mmol/L in females are considered healthy, whilst levels LOWER than these are considered to place individuals into the ‘at risk’ category.

LDL (Bad) Cholesterol

When LDL (bad) cholesterol circulates in the blood, it can slowly build up in the inner walls of the arteries that feed the heart and brain. This ‘plaque’ is a thick, hard deposit that can narrow the arteries and make them less flexible. Heart attack or stroke can result if a clot forms or an artery is blocked. An LDL cholesterol below 2.59 mmol/L (100 mg/dL) is optimal.

<p.Triglycerides

Triglycerides are a form of fat that the body uses to store energy. Elevated triglycerides can be due to physical inactivity, cigarette smoking, excess alcohol consumption, being overweight/obese, and a diet very high in carbohydrates. Triglyceride levels of less than 1.70 mmol/L (150 mg/dL) are desirable.

Cholesterol Ranges

Total Cholesterol

• Less than 5.18 mmol/L = Lower Risk
• 5.18 to 6.19 mmol/L = Borderline High
• 6.20 mmol/L and above = Higher Risk

HDL (Good) Cholesterol
• Less than 1.04 mmol/L = At Risk
• 1.04 to 1.52 mmol/L = Borderline
• 1.55 mmol/L and above = Optimal

LDL (Bad) Cholesterol
• Less than 2.59 mmol/L = Optimal
• 2.60 to 3.34 mmol/L = Near Optimal
• 3.35 to 4.11 mmol/L = Borderline High
• 4.12 to 4.89 mmol/L = High

• 4.90 mmol/L and above = Very High

Triglycerides
• Less than 1.69 mmol/L = Normal
• 1.70 to 2.24 mmol/L = Borderline High
• 2.25 to 5.63 mmol/L = High
• 5.64 mmol/L and above = Very High

Test Procedure

Performing a CardioChek test couldn’t be easier.
• Take a 15-40µl fingerprick sample
• Dispense the blood sample onto the relevant test strip
• Read the results. Simple!

Data

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

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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

Cardiochek PA Blood Analyser - BHR PRO 2013-07-09 11-59-51

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

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HDL Cholesterol
CardioChek PA Linear Regression: Y= 1.02x + -0.06
Cholestech LDX Linear Regression: Y= 0.93x + 0.16

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2005 CardioChek PA MHRA Evaluation Report 05051

Cholesterol
CardioChek PA Linear Regression: Y= 0.76x + 1.52

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HDL Cholesterol
CardioChek PA Linear Regression: Y= 1.02x + -0.06

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1995 Cholestech LDX MDA Evaluation Report: MDA/95/23

Cholesterol
Cholestech LDX Linear Regression: Y= 0.95x + 0.11

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HDL Cholesterol
Cholestech LDX Linear Regression: Y= 0.93x + 0.16

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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

CardioChek PA Technical Specification

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FAQs

How is a blood sample collected?
A small drop of fingerstick whole blood must be collected using a lancet and plastic blood collector provided in the test strip package.

How much blood is needed for each test strip?
Single chemistry tests (Cholesterol, HDL, and Triglycerides), require 15µl of whole blood. Plastic blood collector collects exact amount of blood required for the test.

How are the settings changed on the CardioChek analyser (i.e. time, date, language, etc.)?To change the settings on the CardioChek analyser, go to the USER SET prompt and press the “Enter” button and simply follow the prompts.

How is LDL cholesterol calculated?
First, test cholesterol, HDL cholesterol and triglycerides using new, unused test strips. Then use the following formula to calculate your estimated LDL cholesterol:
Estimated LDL Cholesterol = Total Cholesterol – HDL Cholesterol – (Triglycerides ÷ 5)

NOTE: To calculate your estimated LDL cholesterol, you must fast for 9 hours prior to testing triglycerides. Never calculate an LDL if test results are outside the range of the CardioChek analyser (denoted by a < or > on the results screen) or if your triglycerides are >400.

What if “<”,”>” is displayed on screen or other unexpected results occur?
• Results are above or below measuring range.
• High temperatures affect the strips. Be sure the vial of strips has not been stored in extreme conditions.
• Be sure the vial has been tightly capped immediately after removing any test strips. The test strips should not be removed from the vial until they are ready to be used because the strips are adversely affected by humidity. Remove one strip at a time and recap vial tightly.
• Be sure whole blood was used.
• Be sure an adequate sample size was used. Too much or too little blood may give an inaccurate result. The plastic blood collector ensures accurate volume.
• Be sure blood was applied to the test strip with the test strip already inserted in the analyser.
• Check to see if the batteries need to be replaced.
• Use a check strip, provided in the kit, and make sure it passes.
• Clean the optical glass in the analyser where the strip is inserted (see instructions for proper cleaning in the user manual). Also, make sure the optical glass is scratch free.
• Check the back of the strip after testing. The membrane must be a uniform color. If there are any blotches, the test results may be affected. Test again with a fresh, unused test strip.

What if the analyser reads ‘CHECK STRIP FAILED’?
• Inspect the optical glass in the analyser where the test strip is inserted. It should be clean, dry and free from fingerprints. If not, clean with alcohol wipe and dry immediately with gauze or lint-free cloth or tissue.
• Check to see if the check strip (gray plastic strip that comes with analyser) is damaged or dirty. If so, clean with soap and water or alcohol wipe, or replace.
• Be sure the check strip has been inserted right side up.
• Be sure the meter has not been dropped or stored in extreme conditions.
• Be sure the analyser is being operated inside, away from direct sun or lamp light.
• Check to see if the batteries need to be replaced.

What if the CardioChek analyser will not recognize the Memo Chip?
• Be sure the Memo Chip was installed properly. The notched side of the Memo Chip faces up.
• Be sure the chip was inserted before the analyzer was turned on. If not, press the “Enter” button twice so the analyzer can recognize that the Memo Chip has been inserted.

Case Studies

Leicester PCT
The Leicester PCT project has been a complete success and is the model being adopted by many other PCTs across Britain. The project has been written up and is now considered to be the gold standard by the UK National Screening Committee (NSC) and published as ‘The Handbook for Vascular Risk Assessment, Risk Reduction and Risk Management’ in March 2008. Further copies of this book can be obtained from www.screening.nhs.uk/vascular.

The population of Leicester is 300,000 of which 17,000 are Diabetic. 40% are of ethnic origin, 25% are Obese, 25% are Smokers and 17% Abuse Alcohol.

Death rates from all forms of illness are 20% higher than would be expected and Leicester is 20th most deprived area in Britain. The Leicester PCT introduced a Cardiovascular Health Check Scheme. The CardioChek PA was used to provide the lipid profile for all patients involved in the scheme.

The scheme involved Pharmacists and other Healthcare professionals targeting groups most at risk including middle aged men from ethnic group. The protocol involved an I.T. Health Screen Questionnaire relating to Weight, Height, Medication, and Smoking etc.

The test were performed by the Professional who then lifestyle advice and possible referral to GP.

Captured results were sent to PCT for collation.

North Tyneside PCT
The government identified men over 50 in deprived areas as a priority for health improvement initiatives. North Tyneside PCT decided to set up a project based on high street pharmacies to screen such men for CHD. The PCT pharmacy team took the lead developing the programme, recruiting pharmacists and arranging training. Clinical Chemistry at North Tyneside General Hospital (NTGH) was asked for assistance in selecting and using the point of care testing devices for blood glucose, total and HDL cholesterol. Others in the team were a secondary-care dietician, consultant community cardiologist, vascular disease nurse specialist and a GP.

The CardioChek was selected for lipid tests. Training in use of the meters was given by company representatives to the participants. 18 high street pharmacies joined the project, and sessions were also held in venues such as community halls and working men’s clubs.

This project is continuously being refined and is still ongoing.

Islington PCT
On 11th August 2008, 11 pharmacies in the most deprived areas of Islington, London were commissioned by the Islington Primary Care Trust for a 6-month pilot assessing cardiovascular risk using Cardiochek for lipid tests.

Islington is the first borough in the country to implement this pilot pharmacy-based screening project, leading the way in taking steps to widen access to health advice and to combat the prevalence of CVD in the borough

Rachel Tyndall, Islington PCT’s Chief Executive (12th August 2008).

Mid Essex PCT
Lyn Mowforth (Health Promotion Advisor, Mid Essex PCT) regularly organises public health awareness events with over 3,000 attendees, many of which wish to have their cholesterol checked. As many as 140 members of the public are tested in a single day at an event. Lyn said her CardioChek PAs were fantastic for promoting health to the general population.

Lyn was able to identify those with raised risk factors and advise them on healthy lifestyle choices, while referring the most at risk to their GPs. Portability, ease of use and reliability are the main factors to consider when choosing a lipid analyser for projects such as this.

Surrey PCT
Liz Patroe (Service Improvement Manager for Surrey Heart and Stroke Network) uses the CardioChek PA for primary care based health checks. The Surrey Heart and Stroke Network aims to identify the patients most at risk of a future, significant cardiovascular event using the Qrisk2 algorithm. CardioChek PA is the analyser of choice to provide all the lipid profiling for the patients. The work being carried out in Surrey has revealed some surprising results, especially regarding health discrepancies between male and female patients.

Asda
Asda have taken the decision to improve their testing service by including total cholesterol and HDL cholesterol testing into their current scheme of blood glucose, pressure and BMI. Thus, they will commence a programme on 2nd January 2010, offering a cardiovascular programme in line with the Department of Health’s requirements into 2010.

For the first two months Asda will offer a free testing service to the public in pharmacy which will include blood pressure, blood glucose, a BMI estimation and cholesterol tests. After the initial period; Asda plan on charging a nominal fee to cover the cost of the operator and testing equipment. Asda have funded the project internally as part of the business development of pharmacy.

Each store is being trained at present with a high level of motivation and enthusiasm to start in the New Year.

Coventry PCT
In Coventry over half the adult population is overweight and 23% are clinically obese. Of the children aged 5-15 yrs living in Coventry, 28% of girls and 22% of boys are overweight. 18.5% are obese. 60% of the population eat less than 5 portions of fresh fruit and vegetables per day. Only 22% of the population travel to work on foot, bicycle or public transport.

In January 2007, a new pilot study was launched by Coventry Teaching Primary Care Trust using the skills of pharmacists to offer lifestyle advice for people to manage their weight over the long term. The scheme, “Management of obesity with associated risk factors”, provides an individualised, pharmacist-led service for patients with a body mass index of 30 to 35, with at least one diagnosed or established risk factor, such as hypertension, type 2 diabetes, raised total cholesterol or waist circumference greater than 102cm for men and 88cm for women. During the pilot, 10 pharmacies in Coventry provided the weight management service, with a target of helping 15 patients per pharmacy during the 12 months. The weight management service was set up collaboratively with a number of stakeholders including the Department of Health, five pharmaceutical companies (including BHR), Unichem Professional Services and leading obesity experts including Dr Terry Maguire.

After 6 months, around 140 overweight individuals have been recruited to the scheme and some 400 follow-up appointments had taken place.

Thirty of the patients who completed the first year of the Coventry Community Pharmacy Weight Management Project shed a combined total of around 20 stones (127.3kg), supported by regular

visits to their local chemists to be weight and get helpful tips. Many of them also lowered their blood pressure and cholesterol levels as a result.

Ashwin Hindocha, owner of Mount Nod Pharmacy in Coventry, shares his enthusiasm for the 12-month scheme. He points out that the response from patients has been excellent: “We have been fortunate in the sense that they do want to lose weight — they started with a positive outlook.” Mr Hindocha stresses that the scheme is about health management, not just about obesity and losing weight, and underlines the importance of conveying this thoroughly to the participants. The patients and pharmacists look at other risk factors such as diabetes, cholesterol, blood pressure or any related medication that the patient is on. For example:

They look at their cholesterol and they want to do something about it.

Sainsburys
The Sainsburys Cardiovascular health checks programme started in April 2009 with a plan to test 75,000 people across the UK, offer lifestyle advice and increase sales of Flora ProActive. The campaign ran till August 2009 when the 75,000 tests were completed. The tests were offered to all the public. This proactive screening programme was funded by Unilever to increase awareness of the risks of high cholesterol and the value of using cholesterol lowering foods. A free cholesterol test throughout the 189 Sainsbury’s stores where there was a pharmacy present together with discount vouchers for product and posters to market the campaign.

Sainsbury’s used the triple test strip providing total cholesterol, HDL-cholesterol and blood glucose to provide a substantial cardiovascular screen. The benefit of the triple test strip with CardioChek was the immediate result, the impact to the customer and it met N.I.C.E guidelines on cholesterol testing which is a minimum of total cholesterol and HDL-cholesterol. The traffic light system was used, and customers found to have cholesterol between 5.0mmol/L and 6.5 mmol/L and a HDL of less than 1mmol/L were given dietary and lifestyle advice whilst those with a cholesterol level greater than 6.5mmol/L were referred to their General Practitioner immediately.

Feedback from the pharmacy team at Sainsbury’s is that this campaign has been the single most successful in their history and has brought pharmacy much closer to the core business through the provision of testing and advisory services adding clear value to both Sainsbury’s and the customer alike.

75,000 people across the UK have been screened for CVD risk, and where necessary signposted to the GP for follow up. The service has been very positively received by pharmacy and customer, and in the eyes of Sainsbury’s corporation, has provided a very valuable ethical service to the customer: to guide people into living healthier lives through proper lifestyle advice both through better eating habits and also increased physical activity levels.

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