CardioChek PA User manual

INSTALL
MEMO-CHIP
RUN TEST MEMORY UTILITY SETTINGS
This section is
concerned
with running
client blood
tests
This section is
used to
recall
previous
results
This section is
used to
conduct the
OPTICS
CHECK
This section is
used to
adjust time,
date & units
INSERT STRIP
APPLY
TESTING
CHEM
CONTROL
EXIT
CHECK STRIP
RUN
CLEAR
MEMORY
PRINT
SOUND
SET TIME
EXIT
SET DATE
UNITS
EXIT
Using the CardioChek®PA Analyser
The Navigation Menu





Use this selection to undertake an OPTICS CHECK
at the beginning of every day when you plan to
conduct tests.
Use this selection to CONDUCT CLIENT BLOOD TESTS. When you have
inserted a strip, the display will automatically change to APPLY SAMPLE.
Once the sample is applied, the display will change to TESTING.
Use this selection to RECALL client results. Useful if the analyser switches
off during the health check or you need to refer back to previous tests.
The previous 30 test results are stores by date and time.
RESULTS
2½ mins
Quick Guide

@healthdiags
www.healthdiagnostics.co.uk
Quick Guide
• Turn CardioChek unit on by pressing or the next button, the unit will display
install memo chip. Do not insert the Memo chip at this stage.
• Press the “Next” button three times and the unit will display utility.
• Press “Enter” button and the unit will display check strip.
• Insert the grey optics check strip with strip guides facing upwards, as shown, and press
the “Enter” button.
• The unit will conduct test and display passed. The unit has
passed the optics check strip test. Remove the check strip
and store safely.
• Press the “Next” button until you see the word exit and
then press the “Enter” button.
• This takes you back to the main menu. Press THE “Next”
button until you see the word run test.Now put your
memo chip in and use the machine for testing.
What happens if the check strip fails?
If when conducting an optics check, the unit displays failed inspect the check strip and
make sure the strip is not dirty or damaged. Clean the CardioChek optical window with a
soft, lint-free, damp cloth and allow to dry, then test again with the second grey optics
check strip supplied with your unit. Further strips can be purchased from Health Diagnostics.
These are classed as a consumable item and should be replaced every 6 months or before
depending on the level of usage.
If the unit fails again, please email [e-mail]
Conducting an optics check test - CardioChek
Side 1 of 1
IMPORTANT INFORMATION
When inserting and removing the optics check strip and any of the test strips you must keep them as
flat as possible and DO NOT INSERT AT AN ANGLE. Failure to follow this procedure may result in damage
to the plastic locators on either side of the optical window

Quick Guide
Side 1 of 1
CardioChek error messages and what they mean
LOW TEMP
Device is below acceptable operating temperature.
Move to warmer environment and test after device reaches optimal temperature
(20 –27 °C). If the strips are stored in same location as unit, the strips will also need
to be brought to the same temperature. Do not place unit or strips on a direct
heat source, e.g. radiator
FAILED
Displayed
during optics
check test
The analyser may need cleaning or the optics check strip is dirty or damaged.
Wipe the optics strip, clean analyser slot with a clean, damp, lint-free cloth. Use
your alternate optics check strip. If check strip still fails call Health Diagnostics.
TEST ERROR
Insufficient sample has been added to test strip.
Test again with a new test strip and make sure the correct volume of sample is
used. Check you are using the correct size pipette for the strip being used. Fill to
the line, with no air bubbles present.
MEMO CHIP
ERROR
Memo chip is defective. Use another Memo chip from the same lot.
TEST
ABORTED
Test strip was not properly inserted or was removed before test was complete.
Test again with fresh test strip.
INSTALL MEMO
CHIP
Memo chip is not properly inserted or is defective. Remove memo chip and insert
again. If same error, try a new memo chip ensuring it has the same code as the
strips to be used.
EXPIRED LOT
Tests strips are expired, wrong memo chip is inserted or the date is not set
correctly. Check test strip expiry date and make sure correct memo chip
inserted. Check date setting on CardioChek analyser.
REPLACE
BATTERIES
Batteries need to be replaced. Replace both batteries with new high quality AAA
batteries. (The analyser will not run tests until batteries are replaced).
Result reads
< (less than)
Result is below the measuring range of the test. If the patient has symptoms call a
healthcare professional immediately. Repeat the test. Run controls and confirm
controls are in range.
Result reads
> (greater than)
Result is above the measuring range of the test. If the patient has symptoms call a
healthcare professional immediately. Repeat the test. Run controls and confirm
controls are in range.
If you experience any difficulties that you have trouble rectifying yourself, please
contact our support team on: [e-mail].
Quick Guide
@healthdiags
www.healthdiagnostics.co.uk

Quick Guide
Preparing to test
Remember to:
• Put gloves on.
• Have cotton swab or tissue ready.
• Prepare lancet - single usage, protective cover removed.
• Prepare 1 x 40µL plastic pipette (or 40µL heparin tube and plunger).
• Prepare a plaster for puncture wound (hypoallergenic).
• Orange memo chip for test to be conducted and checked against the batch to
ensure they are within date.
• CardioChek analyser, switched on and optics checked (grey strip).
• Have clinical waste sack within easy reach.
• Have sharps bin within easy reach.
• Finally take out orange and black test strip, not more than 2 minutes before
applying sample.
Conducting a TC/HDL/Glucose test
Side 1 of 2

@healthdiags
www.healthdiagnostics.co.uk
Conducting a TC/HDL/Glucose test
When conducting a combined TC/HDL/Glucose test you must not use the first droplet of
blood. Wipe the first droplet of blood away with a cotton swab or tissue. Gently massage the
finger to obtain the second droplet of blood, sufficient to fill a 40µL pipette. You must not press
around the puncture wound as this will alter the composition of the sample.
• Ensure you have the Orange memo chip in the machine and
Orange & Black test strip is inserted in the unit.
• Use a new disposable lancet to puncture skin (see finger stick
technique fact sheet for full instructions on how to obtain a blood
sample).
• Gently massage the finger and ensure you get a large droplet of blood before
drawing the blood into the pipette/tube.
• Place the 40µL pipette/tube into the droplet and fill to the line. The blood is drawn up
automatically by capillary action. Fill quickly, without air pockets.
• To express the blood out of the pipette/tube, squeeze the bulb on the plastic
capillary pipette or push the black plunger down if using glass tubes with plungers,
ensuring all of the blood is pipetted onto the strip.
• Press the button to RUN THE TEST. The test takes approximately 2½ minutes and
then the results are displayed.
Once the test has completed the machine will beep. The results will appear in the
following order, Total Cholesterol, HDL Cholesterol, Glucose, and finally the TC/HDL Ratio.
To scroll through results press the button, making a note of each result as it appears.
REMEMBER...
• CONDUCT AN OPTICS CHECK AT THE BEGINNING OF EACH DAY BEFORE USING THE ANALYSER.
• MAKE SURE YOU HAVE THE CORRECT STRIP.
• DON’TFORGET TO WIPE AWAY THE FIRST DROPLET OF BLOOD.
• WAIT FOR THE NEXT DROPLET TO FORM BEFORE PIPETTING -YOU WANT TO FILL THE TUBE QUICKLY, NOT A
LITTLE AT ATIME, IN ORDER TO AVOID AIR POCKETS AND UNDER FILLING THE TUBE.
• IF YOU DON’TAPPLY ENOUGH BLOOD TO THE TEST STRIP THE TEST WILL BE VOID, SO IF YOU THINK YOU HAVE
NOT COLLECTED ENOUGH, BEFORE APPLYING TO THE TEST STRIP, WIPE THE WOUND AGAIN, TAKE ANEW
PIPETTE, AND TAKE ANEW SAMPLE.
Side 2 of 2

Quick Guide
Preparing to test
Remember to:
• Put gloves on.
• Have cotton swab or tissue ready.
• Prepare lancet—single usage, protective cover removed.
• Prepare 1 x 30µL plastic pipette (or 30µL heparin tube and plunger).
• Prepare plaster for puncture wound (hypoallergenic).
• Green memo chip for test to be conducted and checked against the batch to
ensure they are within date.
• Cholesterol analyser, switched on and optics checked (grey strip).
• Have clinical waste sack within easy reach.
• Have sharps bin within easy reach.
• Finally take out a green test strip, not more than 2 minutes before applying sample.
Conducting a TC/HDL test
Side 1 of 2

Conducting a TC/HDL test
When conducting a combined TC/HDL test you must not use the first droplet of blood. Wipe
the first droplet of blood away with a cotton swab or tissue. Gently massage the finger to
obtain the second droplet of blood, sufficient to fill a 30µL heparin tube. You must not press
around the puncture wound as this will alter the composition of the sample.
• Ensure you have the Green memo chip in the machine and Green
test strip is inserted in the analyser.
• Use a new disposable lancet to puncture skin (see finger stick
technique fact sheet for full instructions on how to obtain blood
sample).
• Gently massage the finger and ensure you get a large droplet of blood before
drawing the blood into the pipette/tube.
• Place the 30µL pipette/tube into the droplet and fill to the line. The blood is drawn up
automatically by capillary action. Fill quickly, without air pockets.
• To express the blood out of the pipette/tube, squeeze the bulb on the plastic
capillary pipette or push the black plunger down if using glass tubes with plungers,
ensuring all of the blood is pipetted onto the strip.
• Press the button to RUN THE TEST. The test takes approximately 2½ minutes and
then the results are displayed.
Once the test has completed the machine will beep. The results will appear in the
following order, Total Cholesterol, HDL Cholesterol and finally the TC/HDL Ratio. To scroll
through results press the button, making a note of each result as it appears.
REMEMBER...
• CONDUCT AN OPTICS CHECK AT THE BEGINNING OF EACH DAY BEFORE USING THE ANALYSER.
• MAKE SURE YOU HAVE THE CORRECT STRIP.
• DON’TFORGET TO WIPE AWAY THE FIRST DROPLET OF BLOOD.
• WAIT FOR THE NEXT DROPLET TO FORM BEFORE PIPETTING -YOU WANT TO FILL THE TUBE QUICKLY, NOT A
LITTLE AT ATIME, IN ORDER TO AVOID AIR POCKETS AND UNDER FILLING THE PIPETTE.
• IF YOU DON’TAPPLY ENOUGH BLOOD TO THE TEST STRIP THE TEST WILL BE VOID, SO IF YOU THINK YOU HAVE
NOT COLLECTED ENOUGH, BEFORE APPLYING TO THE TEST STRIP, WIPE THE WOUND AGAIN, TAKE ANEW
PIPETTE, AND TAKE ANEW SAMPLE.
Side 2 of 2
@healthdiags
www.healthdiagnostics.co.uk

Quick Guide
Check the test strips and the memo chip match for each test to be
conducted. Check the strips have not expired (date and code on the side of
the tube)
Prepare for the test by setting out
1. Correct size pipettes for the strips being use
• 15µL pipettes for single test strips (cholesterol only or, glucose only)
• 30µL pipettes for dual combined strips (TC/HDL and TC/GLU)
• 40µL pipettes for triple combined strips (TC/HDL/GLU)
2. Test strip and memo chip (check expiry dates)
3. Lancet, swab and plaster
Procedure
1) Choose the index finger on the non-dominant hand.
2) Ensure finger is clean, wipe with dry cotton swab/tissue. If finger is dirty ask
patient to wash hands.
3) Twist off the protective cover on the lancet (do not pull, the grey plastic
shield will come away).
4) Press the lancet firmly against the finger and fire the lancet. Do not lift the
lancet away until it has fired properly.
5) Dispose of the lancet immediately in the appropriate clinical waste
container.
6) Wait for the first droplet to form. It may take a few seconds so be patient.
This first droplet must be wiped away.
7) Gently massage the finger from the base upwards, avoiding applying
pressure to the site around the finger prick.
8) Hold the finger applying even pressure along the length of the client’s
finger as the droplet forms.
9) Hold the pipette between two fingers ensuring you don’t squeeze the
pipette bulb when using the plastic pipettes and don’t cover the hole
near the fill line.
10) Place the end of the pipette into the droplet. Avoid touching the skin
especially avoid scraping it along the skin, in an attempt to scoop up
blood. Capillary action will automatically draw the blood up the tube.
You must fill to the line.
Side 1 of 2
TIP If the finger appears to have stopped bleeding, wipe the finger firmly with a
cotton swab or tissue and re-apply an even pressure.
Conducting a finger stick test

@healthdiags
www.healthdiagnostics.co.uk
Conducting a finger stick test
11) Once you have filled the pipette, ask the client to press the swab firmly against their puncture
wound whilst you finish testing.
12) Position the filled pipette over the ‘well’ on the test strip and squeeze the pipette bulb to dispense
the sample into the ‘well’.
13) If the blood doesn’t come out, place a finger gently over the small hole, which is located on one
side of the pipette in line with the fill line, and then squeeze the bulb of the pipette. Blocking off this
hole ensures the pipette is emptied fully. Dispose of the pipette in the appropriate waste sack/bin.
14) Take the strip out of the analyser and turn it over to check that there has been a reaction for each
analyte. One or more circles on the underside of the strip will have turned a shade of blue
(depending on the test strip). If you have a test error, check if there are any white patches within
any of the coloured circles, as this indicates that the reaction was not complete. This could be due
to under fill or the blood sample being left in the pipette too long before dispensing.
15) Offer a plaster for the client’s finger if necessary - ask if they are allergic to plasters.
16) Write down the results once the test is complete - this takes approximately 2½ minutes.
17) Dispose of all clinical waste appropriately.
•
REMEMBER THESE TIPS...
• DON’TFORGET TO SWITCH THE MACHINE ON.
• CONDUCT AN OPTICS CHECK AT THE BEGINNING OF EACH DAY BEFORE USING THE ANALYSER.
• MAKE SURE YOU HAVE THE CORRECT STRIP AND MEMO CHIP IN PLACE BEFORE CONDUCTING THE TEST.
• DON’TFORGET TO WIPE AWAY THE FIRST DROPLET OF BLOOD.
• WAIT FOR THE NEXT DROPLET TO FORM BEFORE PIPETTING (YOU WANT TO FILL THE TUBE QUICKLY, NOT ALITTLE
AT ATIME, IN ORDER TO AVOID AIR POCKETS AND UNDER FILLING THE PIPETTE.
• IFTHE BLOOD DOES NOT COME OUT AUTOMATICALLY WHEN YOU GENTLY SQUEEZE THE BULB OF THE PIPETTE,
DO NOT RELEASE THE PRESSURE BUT PUT YOUR FINGER OVER THE HOLE ON THE FILLING LINE AND CONTINUE TO
SQUEEZE THE BULB.
• IFYOU DON’TAPPLY ENOUGH BLOOD TO THE STRIPS THE TEST WILL BE VOID, SO IF YOU THINK YOU HAVE NOT
COLLECTED ENOUGH, BEFORE APPLYING TO THE TEST STRIP, WIPE THE WOUND AGAIN AND TAKE ANEW PIPETTE
AND TAKE ANEW SAMPLE.
• CLEAN THE AREA BELOW THE TEST STRIP REGULARLY WITH ALINT FREE CLOTH.
Side 2 of 2

Quick Guide
Side 2 of 2
It is important to eliminate as many of the operator and storage issues as possible before
carrying out any test.
The environment
• The unit and strips need to be at ambient room temperature (no less than 20°C), to
enable accurate readings. If the temperature in the consulting room is too low, the results
will be lower than expected. Do not try to accelerate the warming-up of the analyser or
strips by putting on a direct heat source like a radiator. The strips will take longer than the
unit to be at the correct temperature.
• The manufacturer states that ‘direct light’ may adversely affect test results. Avoid storing
or using the analyser in direct light, such as sunlight, spotlight, under a lamp or by a
window.
The analyser
• The unit must be optics checked using the grey strip
supplied. At the beginning of the day, when in use.
• The glass analyser panel, where the red lights are, must be
kept clean and scratch free at all times. Clean with an
alcohol swab and dry with a lint free cloth. Ensure there
are no smears on the glass.
• Batteries should be changed regularly (every 200 tests) or
when indicated to do so by the unit.
Storage
• All strips should be kept in the plastic tubes with the silica bag and with the lid fully closed
at all times to maintain the correct storage conditions. Atmospheric moisture will
compromise the strips.
• Avoid extremes of hot and cold temperatures as this can seriously affect the chemistry on
the strips.
• Once the strips have been opened they should be stored carefully and ideally be used
within 3 –6 months. The strips contain sensitive chemicals and they can degrade over
time.
• Avoid removal of the strips too prematurely. Only remove the strip just prior to collecting
blood sample.
• Do not store memo chip in the tube with the strips as this may cause contamination of
strips and damage to the chip.
CardioChek Accuracy Tips
Side 1 of 2
Glass analyser
panel

@healthdiags
www.healthdiagnostics.co.uk
CardioChek Accuracy Tips
Testing
• Swabbing the finger with alcohol can leave residue on the finger and can affect the
sample by up to 30%.
• Therefore, avoid using alcohol swabs and use a dry cotton swab or tissue. If the client’s
finger is dirty, ask them to wash and dry their hands.
• Ensure that the first blood droplet is wiped away and not used. This first droplet can be
contaminated, so use the second droplet only.
• The correct volume of blood must be collected as under or over filling may affect the
results: Check it is full to the fill line and there are no air pockets.
15 µL (microlitres) for the single test strips.
30 µL for the dual combined test strips.
40 µL for the triple combined test strips.
• Avoid leaving the blood in the pipette for too long before pipetting, as coagulation or
clotting will occur.
• The full blood sample must be pipetted into the well on the strip.
Start the test immediately after adding the sample. If the test does not start automatically,
you should press to 'RUN TEST'. If the testing is delayed, it will mean the accuracy of the
results may be affected.
Side 2 of 2

Quick Guide
Conducting a Quality Assurance test
Side 1 of 2
To ensure the continuing accuracy of your CardioChek PA analyser, the WEQAS (Wales
External Quality Assurance Scheme) provides monthly external Quality Assurance test
samples. Please note for best results the sample should be used on the day you receive it. If
you are unable to use the serum sample on the day, it can be refrigerated and must be used
within 14 days.
What you need:
• CardioChek PA® analyser •Serum sample received
from WEQAS
• MiniPet® pipette and tip •TC & HDL cholesterol
supplied when you joined the QA scheme combined cassette x 1
30 minutes before testing
• Remove the serum sample from fridge and remove it from the
transport packaging.
• Remove test cassette from the fridge but do not remove from foil
pouch.
• Allow serum to reach room temperature (20°C). This should take
MINIMUM of 30 minutes. Do not accelerate this by putting them near
a heat source e.g. radiator.
Preparing for analysis
• Switch on the analyser and conduct an ‘Optic Check’ on the
device.
• Wearing gloves remove the strip from the tub and place it in the
CardioChek.
Don’t forget to reseal the tub of strips
• Prepare the MiniPet® by placing a tip firmly on the end. A new disposable micropipette
TIP is supplied with each sample.
• Mix the sample by gently inverting 5-6 times followed by swirling gently for 5-10 seconds
(continued overleaf)
Use your green 40µL Minipet®
with TC/HDL/Glucose strips
Use your purple 30µL Minipet®
with TC/HDL strips
Version 2.0

@healthdiags
www.healthdiagnostics.co.uk
Conducting a Quality Assurance test
Analysing the sample
• The test must be conducted within 2 minutes of removing the strip
from its tub.
• Insert the microchip in the CardioChek (if necessary) and use the
menu to access the normal blood sample process, as if you were
testing a client.
• Insert the microchip into the CardioChek Place the cassette in the
LDX® analyser and press RUN.
• To draw up the sample, push in the plunger on the Minipet® as far
as it will go.
• Insert the pipette tip to the bottom of the vial and slowly release the
plunger to draw an accurate volume of serum into the pipette tip.
To ensure no air is drawn into the sample, ensure the tip remains at
the bottom of the vial.
• You should only use a sample which is free from air bubbles
• When correctly filled, place the pipette over the sample ‘well’ on
the strip.
• Push down on the plunger in one continuous action so the entire
sample is released into the well.
• DO NOT RELEASE THE PLUNGER until you have lifted the pipette tip
from the well otherwise some sample may be drawn back up into
the pipette tip, and an incorrect volume will have been applied to
the test strip.
• Make a note of each result and see the next page for instructions
on how to submit to the laboratory.
• Remove the strip from the analyser and check that the circles on
bottom are coloured purple. If testing TC/HDL/Glu, three of the
circles will be coloured purple. This indicates that the QA material
has been correctly sampled and reacted fully.
• Dispose of the strip in clinical waste.
• Retain your Minipet® micropipette for future use
• Please note there will be a charge if the pipette holder—the Minipet® is disposed of in
error
Side 2 of 2

Quick Guide
Submitting Quality Assurance results
Side 1 of 2
• Results MUST be submitted by the deadline stated in the WEQAS schedule—within 14 days
• External Quality Assurance serum samples are normally dispatched on the first Monday of
every month and usually arrive on the Tuesday. You will be told by email if this varies.
• The sample is stable for 14 days and must be used before it expires.
• When possible, conduct the test on the day the sample arrives.
• Late returns will be recorded and will not be included in performance monitoring reports.
• If you received a test error (e.g. “Reaction did not occur”):
• Look up the error in the ‘Error messages and what they mean’ quick guide to establish
why the error occurred.
• If an error has occurred, please submit the error received to the lab.
• Should your analyser be inadvertently set to the incorrect units-of-measure for the UK, you
will still be able to upload your QA results to WEQAS, as the QA process is also checking the
operator’s level of knowledge and understanding. The standard UK units cholesterol are
millimoles per litre —mmol/L.
• Record keeping - every operator must keep a record of patient results, test cassette lot and
operator identity. Contact Health Diagnostics for a copy of the record sheet. Alternatively
this information is collected automatically when USB cable is used from the LDX to Health
Options® .
Submitting Quality Assurance Test results
When you have conducted a QA test:
• Open the reporting website: www.cuesee.com
• Use the username and password which were allocated to you to log in.
• Enter the results relevant to the test cassette you are using e.g. Total cholesterol
and HDL cholesterol.
• After submitting your results dispose of the sample and pipette tip in the clinical
waste.
• QA results will be available on the website in the forth week on each month.
• Please check each month to see how your analyser(s) performed
Version 2.0

@healthdiags
www.healthdiagnostics.co.uk
Side 2 of 2
Unacceptable Quality Assurance results
What happens if the test returns unacceptable results?
1. If one or more analytes are reported as ‘unacceptable’ on ONE ISOLATED
OCCASION, contact Health Diagnostics on [email protected]o.uk
2. If one or more analytes are reported as ‘unacceptable’ (Non-Compliant) OR
the results HAVE NOT BEEN SUBMITTED (NR) on TWO CONSECUTIVE MONTHS,
YOU MUST STOP USING THE ANALYSER IMMEDIATELY
and contact Health Diagnostics on 01244 669 700
Unacceptable Results
Conducting a QA test requires precision and care. Failure to follow the guidelines may result in one
or more of the analyte results falling outside the acceptable range. The list below highlights some of
the possible causes:
• The sample was not stored correctly before use. It must be refrigerated immediately on receipt
if the test is not conducted straight away. The whole blood sample must be brought up to
room temperature before conducting the test and it must be used within 5 days
• The sample was used outside the expiry period (max. 14 days in a refrigerator).
• The sample was not brought up to room temperature before using.
• The serum was not mixed sufficiently before using. Serum can separate on standing and needs
to be mixed according to the instructions in the QA test guide.
• The strip was not at room temperature before conducting the QA test.
• The unit failed the optics check test.
• The strips had not been stored correctly. They need to be stored at room temperature in their
airtight container. Once opened, all strips in the tub must be used within three months.
• The strip was out of airtight container for too long before the sample was applied. The sample
should be applied within 2 minutes of removing the strip form the tub.
• The sample size applied to the strip was not correct i.e. under or over filled.
• Some of the sample was inadvertently drawn back by the Minipet® by releasing the plunger
while still in the well in the cassette.
• The unit was set to ‘Control’ rather than ‘Whole blood’. The WEQAS serum sample should be
tested as if it were ‘Whole Blood’.

Quick Guide
Clinical background
Side 1 of 2
CardioChek®PA is a portable analyser that measures lipids (and glucose) in whole blood. The test strips are
impregnated with enzymes which on contact with blood “react with the cholesterol” and in doing so
develop a colour pigment at the bottom of the test strip. The colour density is proportional to the amount
of cholesterol in the blood. CardioChek monitors ambient temperature and will not test if the temperature
is less than 18°C. This is a safety mechanism to ensure quality results. If the temperature is below 18°C, the
display will show “Low Temp” the system needs to be brought up to 18°C to allow testing to start, please
remember to warm up the test strips too, as these are the most important part of the testing system. These
can be warmed in your pocket (in the tub and not as an individual strip) to gently bring them up to room
temperature. High temperatures are less of a problem as the operating temperature range is between
18-35°C.
Variation
In any biochemical test, we must accept that there will be some variability, cholesterol levels are dynamic
and change from minute to minute depending on food intake and metabolic function. With regard to
cholesterol, there is a set of guidelines on acceptable variation, developed by the National Cholesterol
Education Programme (NCEP) in the USA. The acceptable variation has been set at:
Total Cholesterol: ± 8.9% HDL Cholesterol: ± 13%
The rule of thumb for acceptable variation is ± 10% so if you measure a cholesterol at 4.8mmol/L, the
acceptable variability is between 4.32-5.28mmol/L. This might seem a wide variability but it does not
actually change the clinical interpretation for the patient. This has been set for the whole diagnostic
industry, not just for CardioChek, but for all methods of measuring cholesterol levels. This covers laboratory
testing systems to point of care systems.
Measuring range
CardioChek has been calibrated to the Roche Integra, laboratory analyser. The measuring range for
CardioChek in whole blood is set out below:
•Total Cholesterol: 2.59 - 10.36mmol/L
•HDL Cholesterol: 0.39 - 2.59mmol/L
•Glucose: 1.11 - 33.3mmol/L
Measurements outside the ranges above will be displayed with a < (less than) symbol in front of the lowest
result measured and a > (greater than) symbol in front of the highest result
measured.
Expected Values
The Department of Health has established a set of guidelines with regard to the levels of measured
cholesterol and HDL cholesterol for the UK. This is based on a screening service and a traffic light system for
detection.
•Below 5mmol/L for total cholesterol, and above 1.02 mmol/L for men and 1.20mmol/L for women for HDL
cholesterol with the ratio of TC/HDL ≤ 5
•Between 5 - 6.5mmol/L for total cholesterol and less than 1.02 for men and 1.20mmol/L for women with
the TC/HDL ratio being ≥ 5
•Above 6.5mmol/L for total cholesterol with HDL levels being below 1.02mmol/L for men
and 1.2mmol/L for women and the ratio of TC/HDL ≥ 6
Guidelines based on the manufacturer’s (PTS Systems Inc.) documentation

Clinical background
Side 2 of 2
Interpretation of results
The guidelines set out above are for the detection and risk assessment of developing cardiovascular
disease. There is some common sense that should be applied in interpreting the results. As a screening
device, CardioChek is an accurate system for the detection of normal, higher than normal and
pathologically high. A single test measurement should not be used for diagnosis. If the patient
measured is higher than the guidelines suggest, a second test should be carried out up to 48 hours after
the initial test, if the result is below 6.5mmol/L, the advice for the patient should be to adjust lifestyle
through reduction of smoking and alcohol consumption and also through diet and exercise. The
patient then should ideally be re-tested 6-8 weeks later to see if there are improvements. If the patient is
persistently reading above 6.5mmol/L, a sample should be sent to the local laboratory for final
confirmation before any kind of intervention takes place or therapy prescribed to lower the risks to
CVD.
In the grey area of just above 5mmol/L, the TC/HDL ratio must take a key role to allow the clinician to
provide the best course of action with the patient. If the ratio is below 5, this indicates that the HDL
levels are much higher and they should be offering some cardio-protection, and therefore a change to
lifestyle would be the best way forward. Other factors also affect the risk assessment, blood pressure,
BMI, smoking and alcohol habits; the cholesterol measurement must take its place as one risk factor
amongst others in the overall review. If the TC/HDL ratio is above 5, this indicates an increased risk, and
advice should be provided to encourage the patient to take action for themselves to reduce the risk of
developing CVD.
Common causes of error
Point of care equipment is only as good as the operator
• When the unit is used incorrectly, it will not produce acceptable results
• When used appropriately it will provide consistent, high quality results adding value to the patient
experience
• Getting as much out of any training and reading any accompanying materials is critical to your
success
Blood sampling
• There should be no stress in achieving the right sample volume with the
correct technique.
• Always wipe the first drop away, this contains tissue fluid and is not
representative of blood.
• Always make sure the finger is clean and dry.
• Clotted blood will not work well, so if the sampling takes more than a
minute, dispose of the pipette correctly and try again.
• Always wear gloves to minimise infection risk.
CardioChek® PA
• Out of operating temperature or test strips not brought to room temperature.
• Using a test strip from a different batch.
• It is unaffected in normal light conditions, but excessive light will affect the result. Please shade the
system from direct sunlight or bright lights in close proximity to the analyser.
PTS Cholesterol Test strips
• Too cold, will produce lower results as enzymes not at correct temperature.
• Using the wrong batch in CardioChek.
• Using strips that are out-of-date.
• Poorly stored strips. Once opened they ideally should be used within 3 months.
Guidelines based on the manufacturer’s (PTS Systems Inc) documentation
@healthdiags
www.healthdiagnostics.co.uk

Quick Guide
Communicating risk
The QRISK2® CVD risk calculator is an algorithm or formula used to show clients how their
current health status affects their cardiovascular health. Health Options® can be used to
show a client their ‘absolute’ risk and their ‘what if you change’ risk.
What is absolute risk?
Absolute risk is a calculated risk assessment which indicates the statistical likelihood of an
individual having a cardiovascular event (stroke, transient ischaemic attack, myocardial
infarction, heart attack or angina) during the next 10 years. It indicates the risk of a CVD
event if the current situation remains unmodified or untreated.
The calculation is derived from population studies and compares the current client’s
measured parameters with those of diagnosed patients. The measured biometric and clinical
parameters used in the calculation are: age, gender, total and HDL cholesterol, blood
pressure, smoking status, ethnicity and family history.
Example QRISK2 screen.
A client with a current absolute risk of 19.4% has
been shown the benefits of reducing blood
pressure, cholesterol and losing weight. Note the
second ‘what if you change’ risk line on the chart
(in pink); the client’s risk has fallen to 11% and their
heart age has fallen from 55 to 48.
The purple line
shows the
current risk score
The pink line shows the
impact of lifestyle
changes
The calculated absolute risk value in the example is 19.4% (the number in the circle, bottom
left). This means that in a population of 100 people with the same age, gender, ethnicity and
health status as the client, it is predicted that 19.4 of those people are likely to have a heart
attack or stroke in the next 10 years. This can also be expressed as a 1 in 5 chance, which
may be easier to understand than a percentage.
The QRISK® Heart Age (number in the circle, bottom right) indicates the client’s calculated
‘heart age’. The higher their absolute risk, the greater their heart age will be. The heart age
value shows the age at which you’d expect a typical person of the same gender and
ethnicity to attain these results.
Side 1 of 2 Version 0.1

@healthdiags
www.healthdiagnostics.co.uk
Communicating risk
What is the ‘what if you change’ risk?
In addition to calculating a client’s current absolute risk, Health Options can show the effect
of a person changing their modifiable risk factors and the impact this could have on their
CVD risk. This has proven to be a highly motivational tool that can be used to signpost clients
to other services such as smoking cessation, getting active and weight management.
•The best way to use the ‘what if you change’ function is to discuss realistic and
achievable changes to the client’s lifestyle which could impact on the results. (e.g. eating
less saturated fat and increasing activity will impact on weight, BP and cholesterol).
•Be aware that some changes will have a significant impact on risk and some will have a
minor effect. Changing a smoker to an ex-smoker, reducing cholesterol and blood
pressure all have a significant impact on the ‘what if’ risk score and ‘what if’ heart age.
Losing weight (and therefore BMI) however has a relatively small impact on a risk score.
The
benefits of losing weight by eating healthily and being more active are reflected in the
measurements which have a greater impact on risk e.g. cholesterol and blood pressure.
Smokers and Ex-smokers
•Smoking has a significant impact on CVD risk. The benefits of stopping smoking are well
documented, however, in reality there is still some persistent risk from having smoked even
after stopping for 5 years. You should therefore recognise that an ex-smoker’s risk is still
going to be between that of a current smoker and a non-smoker.
Alcohol
•Whilst there is no facility to modify alcohol within the QRISK2® calculation (as it is not
directly included in the calculation), excessive alcohol consumption is known to
negatively impact BP and cholesterol. Impaired liver and kidney function can lead to a
number of other health problems. Alcohol affects the skin causing premature ageing and
wrinkles. Alcohol is also fattening and contributes to weight gain and central obesity.
Activity
•Whilst regular moderate physical activity is known to reduce the risk of CVD, there are
issues with the accurately reporting the amount we do and the affect it has. As a result,
activity is not directly included in the QRISK2® calculation. Regular aerobic activity
however will help with weight reduction, improve stamina, boost HDL cholesterol, reduce
stress and improve bone density. Those who engage in regular activity also tend to eat
more healthily which can lead to an improvement in the individuals lipid profile and blood
pressure readings.
Side 2 of 2