Ameristat Pharmaceuticals, Inc.   

Cholesterol Test -

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            $12.99 each + $3.95 S&H (within the U.S.)
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Cholesterol Test Contents
Test card
• Safety lancet
• Alcohol swab
• Instructions


Why test for cholesterol?

Because high blood cholesterol clogs the arteries, it is a major cause of heart disease and stroke. Controlling blood cholesterol levels can reduce the risk of heart problems. The first step is to determine one’s total cholesterol levels.

The EarlyDetect cholesterol test helps you keep track of your cholesterol levels. It is easy to use, done at home, and only one drop of blood is needed. The result shows total blood cholesterol levels.

Patient counseling tips

A clock or timer is needed for this test.

The sealed pouch containing the test card should be kept at room temperature and not be opened until the patient is ready to perform the test.

The kit should not be used after the expiration date printed on the package.

The patient should read and understand the instructions before doing the test, because the test card cannot be reused.

Changes in medication dosage or schedule should not be based on the results of the test.

If the result indicates high or borderline total cholesterol levels, the patient should consult a physician.

The test should not be performed within 3 months of a serious illness or major surgery, or within 3 weeks of a minor health problem such as influenza or diarrhea.

Pregnant women should wait until after delivery to test their cholesterol levels.


How do I use the EarlyDETECT™ Cholesterol Test kit?

Kit contains
This EarIyDETECT™ Cholesterol Kit contains:
• Sealed pouch containing the test card and a moisture absorbent packet to keep it fresh
• Safety Iancet
• Bandage
• Alcohol swab
• This set of instructions
Materials required but not provided:
• Clock or timer
• Clean tissue

Storage & stability
• Store this test kit in its sealed pouch at room temperature (15°-28°C, 59°-82°F).
• Do not use this kit after the expiration date printed on the package

Before you begin
• This EarIyDETECTTM Cholesterol Test is intended for one time use only. Therefore, it is very important that you read these instructions and understand everything you have to do before you begin the test. You must follow the instructions exactly.
• Do not open the pouch containing the test card until you are ready to perform the test.
• Verify that the expiration date printed on the package has not passed.

Intended use
The EarIyDETECT™ Cholesterol Test can be used to identify elevated total blood cholesterol levels that may lead to increased risk of coronary artery disease. All results indicating elevated total blood cholesterol levels should be verified by a health professional. In scientific terms, this test is known as solid phase chemistry, which employs the same principle as the enzymatic wet chemistries that are presently used in many hospital laboratories.

Interpreting the results
To determine your result, match the blue-green color of the Test Area with the six different color blocks that appear in the windows as you slide the color chart up and down. You will have 30 seconds to decide which color block most closely matches your test result before the Test Area begins to fade.

Note: If the Test Area is unevenly colored, match the overall color area of the Test Area to the color blocks on the sliding chart.

After determining the nearest color match, turn the card over. Your total cholesterol reading appears in the clear window marked “mg/dL” and “mmol/L”

• Desirable Range: Below 5.2 mmol/L (200 mg/dL). This is a low risk area. You should    maintain a healthy diet, exercise regularly, and monitor your cholesterol periodically.
• Borderline-High: 5.2-6.5 mmol/L (200-250 mg/dL). This is a moderate risk area. You    should not become unnecessarily alarmed, because there are other factors that must    be taken into account. Your general health, smoking habits, age, weight, and family    medical history all play a role in determining your risk of coronary artery disease. Test    yourself again in 1-8 weeks. If the result is in the borderline-high area again, see your    doctor for another assessment and advice.
• High: 6.5 mmol/L and above (250 mg/dL and above). This is a high risk area. You    should contact your doctor for further tests and advice.

Many things can cause cholesterol readings to vary, including stress, recent diet, rest, exercise, and other biological factors. It is not unusual for results in some people to vary by as much as 10% to 20% over a period of time.

Limitations of this test
• The directions must be followed exactly to provide accurate results.
• Do not open the foil packet containing the test card until you are ready to conduct the    test.
• Do not alter your medication dosage or schedule based on the results of this test.    Discuss    any medication changes with your doctor first.
• Certain rare medical conditions (such as blood bilirubin or hematocrit levels outside the    normal range) may cause your test results to be inaccurate. If you are unsure whether    this lies to you, ask your doctor.
• Cholesterol testing should not be done within three months of a serious health problem    (such as heart attack or major surgery) or within three weeks of a minor health problem    (such as influenza or diarrhea). Pregnant women should wait until after delivery to test    their cholesterol levels.
• Each test card may only be used once. Discard it after use.

This product is FDA registered and manufactured in FDA registered facilities.