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HealthcheX CHO Cholesterol Test Instructions

Read all instructions carefully before starting the test.

Familiarize yourself with the “HealthcheX CHO” test kit.

• Check the contents, if any of the contents are missing broken or opened, do not use the kit - return it to the place of purchase (subject to supplier terms)
• This test is for single use - for external use only – do not ingest any part of the test or any other item contained in the kit.
• Do not open the foil until you are ready to carry out the test
• Once opened, use the device within 30 minutes

HealthcheX CHO– What does it do?

The HealthcheX CHO test is a self assessment test to detect, in vitro, the concentration of total cholesterol in a blood sample obtained from a single finger prick. The kit contains one test in a sealed foil marked “HealthcheX CHO”; for assessing total cholesterol in whole blood sample only.

About Cholesterol

Cholesterol is a greasy substance, mainly produced in the liver. The body also absorbs cholesterol from food. Cholesterol is encapsulated by proteins and transported by blood. The body needs cholesterol to produce certain cells, hormones and for digestion. There are two major kinds of cholesterol: LDL-cholesterol (low-density lipo-protein) and HDL-cholesterol (high-density lipo-protein). LDL-cholesterol, also called “bad” cholesterol, may lead to “arteriosclerosis” or coating of the inside of the blood vessels which can lead to cardiovascular problems. HDL-cholesterol, also called “good” cholesterol, is capable of decreasing the cholesterol concentration in blood. A high level of cholesterol can be caused by a bad diet, excessive alcohol, smoking, overweight and lack of exercise. Diabetes may also cause increased cholesterol levels.

HealthcheX CHO– How does it work?

Once the blood sample has been added to the test well it flows through a membrane that separates the red cells from the plasma. The cholesterol present in the plasma reacts with chemicals coating the membrane resulting in a blue/purple line moving up the scale The migration distance of the coloured line is proportional to the concentration of cholesterol present in the sample. On completion of the test, the highest level that the blue/purple colour reaches on the scale is read off and this value is converted to the amount of cholesterol in the sample using the chart contained in the kit.

Contents of the kit

1. A HealthcheX CHO cholesterol test foil pouch contains a single test device (and a bag containing a desiccant which is not required to perform the test.)
2. 2 x Sterile lancets to allow a blood sample to be taken from a finger prick
3. Adhesive plaster
4. Instructions for use
5. Result conversion chart

Not included:

• A clock or timer
• A paper tissue

HealthcheX-CHO - Test Procedure

Important issues: Before you perform the test:

• Please read the instructions for use thoroughly (this leaflet).
• Make sure you have a clock or timer ready
• The reading area on the test must be white before use. If there is any visible sign of discolouring, do not use the device.
• The lancet can only be used once. Do not use the lancet until you are ready to you perform the test.
• Do not perform the test within a 4 hour period of taking 500 mg or more Vitamin C or a standard dose of Acetaminophen (e.g. Tylenol), or Naproxen. This may result in a lower than expected reading.
• Make sure that everything is at room temperature
• Before drawing the blood sample with a finger prick, wash your hands with soap and water. Rinse them well and dry them thoroughly
• Sit down and try to relax for about 5 minutes
• To increase the blood flow, rub your hands together and let your arm hang at your side for 30 seconds.
• If you are right handed, take the blood from your left hand. If you are left handed, from the right hand.
• Never use a lancet used by someone else.
• Never re-use a lancet
• Use your middle finger, or a finger that does not feel cold and is callus free.

STEP 1:

This is a very important step; read this section on how to draw a blood sample carefully. If after reading this information, you still have questions, please contact the store where you bought the test or call the helpline number listed at the end of this leaflet

• Open the pouch labelled HealthcheX CHO cholesterol test.
• Take out the test device and place on a flat horizontal surface

DO NOT PULL THE TAB UNTIL STEP 4!

STEP 2 :Drawing the blood sample.

Take the lancet, twist the coloured cap and pull it off

• Place your hand, from which you are going to take the blood, flat on the table, palm uppermost.
• Place the lancet with the opening on the side of your finger rather than the tip. Push the lancet down, at first it will travel easily, then you will feel some resistance. Continue to push until you hear a “click” and then you will feel the lancet pierce the skin. After the “click” you can remove the lancet off your finger.
• Wipe away the first drop of blood with a clean paper tissue.
• Position your finger such that the blood drop is directly over the blood well.

STEP 3: Adding blood sample to test device

• You must add enough blood within 3 minutes of piercing your finger, so the black fill circle is covered.
• Point your finger down over the blood well as shown above. Gently massage your finger from the base to the puncture several times. Squeeze and release your finger tip a few times to form a hanging blood drop. Let the drop of blood touch the bottom of blood well on the test device.
• Add more blood as quickly as possible until the black fill circle is covered. Too little Too little Correct
• You can never add too much blood.
• CAUTION: Start your clock or timing device only when the black circle in the test well is covered.
• ONCE YOU HAVE FILLED THE SAMPLE-WELL WITH BLOOD, WAIT
• Wait at least 3 minutes but not more than 4 minutes

STEP 4: (a) Activating the Test

• After waiting 3 minutes but not more than 4 minutes hold the device firmly in your hand. Pull the clear plastic tab on the right side of the device HARD until you see the entire arrow.
• Tap the device a couple of times on the surface of the table and lay it flat on the table.
• The OK indicator turns blue/purple in approximately 5 minutes from the start of the test.
• The end indicator turns green in about 10 – 12 minutes,
• Read the test result after both indicators change colour.
• If one of the indicators did not change colour, the test has not been performed correctly. Repeat the test with a new device. Once activated you cannot reuse a device.

STEP 4 (b) Reading the result.

• Read the result within 30 minutes after the OK indicator changed colour.
• Read the result under bright light. Find the very tip of the blue/purple colour bar in the measurement scale, even if fuzzy or faint.
• Use the result chart “HealthcheX CHO Test Result Chart” to find your level of cholesterol.
• Match the number of the column labelled “Test device reading” with the number in the column labelled“Cholesterol mmol/l”. This is your Cholesterol level.

IMPORTANT: The result chart that came within the test kit is specific for this lot of cholesterol tests. Use only the result chart provided with this kit. A result chart from any other kit may give an inaccurate result.

Understanding Your Cholesterol Test Result

PLEASE NOTE: A single test result should only be considered “indicative” of your cholesterol level and cannot normally be considered “diagnostic”. The result must form part of a full biochemical and clinical analysis. Bearing this in mind, if your cholesterol test result is borderline high, and you have other risk factors e.g. smoking, over weight, no exercise etc., we advise you to contact your GP or do another test after 3 to 8 weeks.

*= NCEP Guidelines III (2005)

If your result is high, please contact your GP immediately.

A high level of cholesterol is one of the most important risk factors for coronary heart disease. (A risk factor is something that increases your chances of getting the disease.)

The other major risk factors are:

• Diabetes
• Smoking
• High blood pressure, or have already had a heart attack, or angina
• Physically inactive
• Not getting enough omega-3 fats
• Not eating enough fruit and vegetables
• Being overweight or obese (very overweight)
• Drinking too much alcohol
• Having too much salt.

There is also a greater risk of heart attacks among people who have familial hyperlipidaemia – an inherited condition in which the blood cholesterol level is very high.

Questions and Answers.

What can I do to make drawing the blood easier?

• Wash hands with warm water.
• Warm hands by rubbing them together.
• Let the arm of your selected finger hang at you side for at least 30 seconds.
• Choose a finger that is callus-free.
• Lay selected hand, palm up, against the table.
• Press the finger stick device firmly against the side tip of your finger. Do not pull away when triggering the finger stick device.
• If you like, someone else can help you prick your finger.

Can both indicators change colour without giving me a correct reading?

Yes, but an inaccurate result will occur if:

• the blood well is not filled with enough blood to cover the black fill circle completely
• more than three minutes have elapsed in filling the blood well,
• you did not wait a full three minutes but not more than4 minutes before pulling the plastic tab
• you did not pull the plastic tab out far enough to see the entire arrow
• you performed the test in direct sunlight.

How accurate is the HealthcheX CHO test?

The HealthcheX CHO test is as accurate as tests used by doctors and medical labs. The HealthcheX CHO test was evaluated in professional studies throughout the U.S. When the instructions were followed carefully and all the steps were performed correctly, the accuracy, on average, was 97%.

Do I need to fast before I take the test or perform it at a specific time of day?

No. You can test yourself at any time, so fasting is not necessary. If you repeat the test, try to do so under the same conditions.

Will common foods, alcohol or medication affect my test results?

Generally not. Most substances will not interfere with the test. However, you should not perform the test within a four hour period if you have taken 500 mg or more of Vitamin C or a standard dose of acetaminophen (e.g., Tylenol) or Naproxen. This could cause a falsely low result.

LIMITS OF THE TEST

• You must follow all directions carefully to get an accurate reading.
• This HealthcheX CHO Test must only be used by adults 18 years of age and older.
• Recent illness, pregnancy, birth control pills and other conditions may change your total cholesterol level. If you are concerned or have questions, talk with your doctor.
• Using this test in direct sunlight may cause an inaccurate result.
• The HealthcheX CHO test is for in vitro diagnostic use only.
• DO NOT INGEST (swallow) any part of this kit.
• As with all diagnostic tests, therapeutic decisions should not be based on a single result or method. In the case of unexpected results, consult your healthcare professional for advice and/on further investigations if needed.
• This test is subject to the inherent variations in biological systems. This may lead to less than 100% accuracy in some cases. Occasionally, the test may produce a false positive or false negative result. Accordingly, results should be treated as a guide to whether further tests and / or advice is sought from healthcare professionals

Follow-up action

If you have difficulty performing the test or understanding the results obtained then contact the place you purchased the product from in the first instance. You should consult your healthcare professional for advice if a positive result is obtained or the test is negative but concerns persist.

WARNINGS

• Not for use by haemophiliacs or those taking medicines that thin blood (anticoagulants).
• Do not use within 1 month of convalescence from an acute illness.
• Use the test before the “Expiry” date on the package.
• Only use the test device once.
• Do not open foil pouch until you are ready to use the test.
• Use only with human finger stick blood drops.
• Not for use with any other body fluids or food, or on animal blood.
• Store between 15o and 25oC (59o and 77oF)
• Do not perform test in direct sunlight.
• Keep out of reach of children.
• Never use a finger stick device that has been used by another person.
• Do not use in the presence of hydrogen peroxide.
• Never adjust your medication based on this test. If you are on long term medication, consult your healthcare professional before carrying out and/or adjusting any therapy based solely on this test.

Discarding the kit:

After your result is known put all contents back in the original box and dispose with your daily household waste products