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CHOLESTEROL
TEST STRIPS
0344
Test strips to use with PRIMA® meter.
PL300 (5 test strips, 1 data-chip)
PL301 (25 test strips, 1 data-chip)
PL302 (5 test strips, 1 data-chip)
PL311 (5 test strips, 1 data-chip)
INTENDED USE
Test strips are used with the PRIMA® Self-Testing Kit meter for quantitative measurement of total cholesterol in whole blood obtained from fin-
gertip. The strips are for testing outside the body (in vitro diagnostic use); intended for in home (self-testing) and point-of-care setting. Before using
these test strips please read this package insert and the PRIMA® user manual carefully.
TEST PRINCIPLE
Each test strip has been chemically pre-treated with enzymes. On each test strip there is a white application area containing reaction chemicals.
When finger-lanced blood is applied to this area, a chemical reaction takes place and the color of the strip changes. The deeper the color the higher
cholesterol level in the blood sample. The PRIMA® meter measures reflectance of light caused by this color change and interprets it into the users
cholesterol value. Your total blood cholesterol level is then displayed on the meter's LCD display.
One cholesterol data-chip (green) is provided with each container of cholesterol test strips and must be properly inserted into analyzer before any
cholesterol test can be run. The chip contains test name, calibration curve, lot number and test strip expiration date. The test measures cholesterol
from 3.3 Mmol/l (130mg/dl) to 10.2 Mmol/l (400mg/dl).
STRIP STORAGE AND HANDLING
•
Do not remove the test strips from the strip container until immediately before performing a test.
•
Check the expiry date of the test strips printed on the container. Do not use out-of-date strips.
•
After opening a new strip container, the strips are stable for 3 months - try using the strips within three months
after you first opened the container.
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This will ensure the most accurate results.
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Tightly re-cap the container immediately after removing a test strip. Exposure to light and moisture may discolor the test strip,
which may lead to false and inaccurate results.
•
Use test strip as soon as you have removed it from the container.
•
Do not cut or alter strips in any way.
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Avoid exposing the strips to extreme temperatures. Store the strip container at 5°- 30°C. Do not freeze.
•
Store the strips only in the original container. Do not combine with other strips.
•
Do not remove or discard the desiccant bag from the container.
•
Keep the strip container away from children.
•
Discard test strip after measurement is completed. Do not re-use strips.
•
Do not ingest.
HOW TO DO A TEST
Please refer to your PRIMA® digital meter's manual for step-by- step instructions how to operate a digital meter, use a lancing device and perform
a measurement.
1) Extract the green data-chip; 2) insert the data-chip; 3) open the vial; 4) take the strip; 5) immediately close the vial; 6) select the gender ("F" for
female, "M" for male); 7) select if before ("A") or after meal ("P"); 8) wash your hands; 9) insert the strip in to the meter with the green side outside;
10) check the display if there is the CH symbol and the number corresponds to the one printed on the vial; 11) get the drop of blood with the lancet;
12) apply the blood on the strip; 13) wait for the result.
TIPS FOR GETTING A GOOD DROP OF BLOOD
The PRIMA® meter and cholesterol test strips require a large hanging drop of blood. If you are new to self-testing, or have had trouble getting blood
in the past follow these steps:
•
Wash hands in warm water, rinse and dry completely. If you use a hand cream, keep in mind that almost all creams contain fat and can af-
fect the triglycerides reading and wash your hands very thoroughly and rinse carefully with clean water to obtain the most accurate results.
•
Warming your hands is always helpful with increasing blood flow to fingertips.
•
Let your arm hang down at your side briefly to allow blood flow to fingertips.
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Grasp the finger near the area to be pricked and squeeze for three seconds.
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Lance side of the fingertip and squeeze gently until you get a drop of blood.
•
Always wipe away the first drop of blood with a cotton ball or gauze. Apply the second drop to the test strip.
WHAT DOES YOUR RESULTS MEAN
The U.S. National Cholesterol Education Program (NCEP) and the Canadian Cardiovascular Society (CCS) strongly recommend to do repeated measure-
ments of cholesterol to find out one's baseline (beginning) value. At least 2 or 3 tests should be performed over a period of 2 or 3 weeks. The average of
these values will give your baseline cholesterol value. The PRIMA® meter has an option to automatically calculate an average of all the tests stored in the
meter's memory (see your manual to set up this option). You may want to see your family physician for more information on your baseline value. Never
adjust or change your medications and diet based on your total blood cholesterol value obtained by the meter – always consult with your physician first.
GUIDE TO INTERPRET TEST RESULTS
Desirable Total Blood Cholesterol
If your result is below 5.2 mmol/L (200mg/dL), your total cholesterol level is "desirable". Record your result in the log book and discuss with your phy-
sician how often you should re-test your total cholesterol. Your level may change over time, especially if you change your diet and exercise routine.
If your result is between 4.9 and 5.1 mmol/l (190-199 mg/dL), your cholesterol level is borderline normal and close to the cut-off value. You should
talk to your physician and confirm your blood cholesterol in a clinical laboratory.
Borderline-High Total Blood Cholesterol
If your test result is between 5.2 to 6.2 mmol/L (200-239 mg/dL), your total cholesterol level is "borderline-high". It means you are at increased risk
for developing a heart disease compared to those with lower levels. It doesn't mean you necessary need intensive medical attention but you should
consult with your physician.
High Total Blood Cholesterol
If your test result is above 6.2 mmol/L (240 mg/dL) you are in the "high risk" category for developing heart disease. One test is not enough to confirm
high blood cholesterol. At least 2 or 3 tests should be performed over the period of several weeks. The average of these values will determine your
true total blood cholesterol level. You should talk to your physician for a complete medical check-up. Total cholesterol is affected by diet and by
your body's metabolic state as well as your genetic makeup. A high cholesterol level is one of the major risk factors of heart disease. However, other
risk factors which can increase the likelihood of heart disease are smoking, high blood pressure, un-balanced diet high in saturated fat, obesity,
insufficient exercise, as well as alcohol abuse and diabetes. If you have any questions about your total blood cholesterol and/or risk factors, consult
with your physician.
Unusual Results
If you keep monitoring your cholesterol levels with the PRIMA® meter regularly and occasionally get unusually high or low results, there may be a
problem. First, check and review your test procedure, integrity of test strips or functionality of your meter (see your manual for a function check
with control solutions).
The following are the most common causes of unusually high or low results:
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Test strips were kept in an opened container.
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Expired test strip was used.
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Proper maintenance and handling procedure for the digital meter have not been followed.
•
The first drop of blood was applied instead of the second. The first drop usually contains
some extracellular tissue fluid that dilutes your blood drop and causes false results.
LIMITATIONS OF THE TEST
Cholesterol test strips give reliable and accurate results under the following limited conditions:
•
Measurement range 3.3-10.2 mmol/L (130-400mg/dL).
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Only fresh capillary blood should be used for testing.
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Recent acute illness, pregnancy, hormonal medications including birth control pills may change
your blood total cholesterol values. If you have any concerns consult with your physician.
•
This test system has not been validated for neonates.
•
The following medications in high concentrations can alter total cholesterol levels: Vitamin C, dopamine,
methyldopa and Tylenol (acetaminophen).
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Excessive squeezing and milking of the pricked site may cause erroneous results.
•
This test should not be used by people who are on the blood thinning medication (anticoagulants) as well as
by patients with bleeding disorders (hemophiliacs etc.).
•
The test should be performed at room temperature (10 - 35 °C).
•
The test should be performed at less than 80% humidity.
ADDITIONAL SUPPLIES
To order Cholesterol Test Strips, in the 5 or 25 strips containers (REF PL302; PL301), as well as Cholesterol Control Solution (PL308), please visit our
website: www.primahometest.com.
LIMITED WARRANTY
Manufacturer of this product warrants that the test strips will meet the specifications stated in the labeling when used in accordance with such
labeling and will be free from defects in material and workmanship until the expiration date printed on the test strips container.
SYMBOLS
In vitro diagnostic device
Read the instructions before use
Temperature limits
Expiry date (last day of the month)
Distributed by
CE marking
Do not reuse
PRIMA Lab SA
Via A. Monti 7 - 6828 Balerna (CH)
List number
Sufficient for
primahometest.com
<n> tests
Lot number
Manufactured by
Biochemical Systems International
Legal manufacturer
52100 Arezzo ITALY
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