INTENDED USE
PTS PANELS HDL Cholesterol Test Strips provide a quanti tative measurement of High Density
Lipoprotein (HDL) Cholesterol. This system is intended to assist in screening for decreased HDL
Cholesterol, a risk factor in coronary heart disease, and is intended for in-home (self-testing) or
professional use.
SUMMARY
HDL Cholesterol, often referred to as “good cholesterol”, is an important component of a lipid profile. A
low HDL indicates increased risk of coronary heart disease, while a high HDL indicates decreased risk.
Individuals should consult their healthcare professional with any questions about HDL levels and when
to use this test. A MEMo Chip
™
is provided with each package of test strips and must be properly
inserted into the analyzer before any test can be run. The MEMo Chip contains test name, calibration
curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and
blood applied to the strip, test results are displayed in about a minute.
PRINCIPLE OF THE TEST
HDL Cholesterol test results are based on a reading of light reflected off a test strip that has changed
color after blood is applied. The deeper the color is, the higher the HDL level. The analyzer converts
this reading into an HDL result and displays it. This procedure is based on the “Trinder Method” for the
determination of cholesterol.
MATERIALS PROVIDED
• PTS PANELS HDL Cholesterol Test Strips
• MEMo Chip (contains lot-specific test strip information)
• Instructions
MATERIALS NEEDED BUT NOT PROVIDED
• CardioChek brand analyzer
• Quality Control Materials
• Lancets for fingerstick (or venous blood collection supplies)
• Alcohol wipes and/or gauze
• Capillary Blood Collector or other precision pipet for blood collection and application
CHEMICAL COMPOSITION
Each HDL Test Strip contains the following active ingredients:
Cholesterol Esterase (Microorganism). . . . . . . . . . . . . . . . . . > 0.6 I.U.
Cholesterol Oxidase (Microorganism) . . . . . . . . . . . . . . . . . . > 0.8 I.U.
Magnesium chloride hexahydrate . . . . . . . . . . . . . . . . . . . . . > 500 µg
D-sorbitol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > 3 mg
Tris buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > 150 µg
Dextran sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > 200 µg
PVA (polyvinyl alcohol) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > 300 µg
MOPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > 200 µg
Sucrose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > 500 µg
Peroxidase (Horseradish). . . . . . . . . . . . . . . . . . . . . . . . . . . . > 1 I.U.
4-aminoantipyrine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . > 12 µg
Substituted aniline derivatives . . . . . . . . . . . . . . . . . . . . . . . . > 30 µg
Each vial contains not more than 5 g silica gel desiccant.
STORAGE AND HANDLING
• Store test strip package in a cool, dry place at room temperature of 68-86°F (20-30°C). Strips may
be stored in a refrigerator at 35-46°F (2-8°C), but must be brought to room temperature before using.
Do not freeze.
• Keep away from heat and direct sunlight.
• Do not remove or discard the desiccant packet in the vial.
• Always replace vial cap immediately after removing a test strip.
• Use test strip as soon as you have removed it from the vial.
• Keep the MEMo Chip either in the analyzer or stored with the original lot of strips.
• Store the test strips in the original vial. Do not combine with other strips and do not store the
MEMo Chip in the test strip vial.
• After opening, the test strips are stable until expiration date if vial is properly stored and always
capped.
PRECAUTIONS
• For
in vitro
diagnostic use. Intended for self-testing.
• PTS PANELS Test Strips can only be used in the CardioChek brand analyzer.
• Make sure the MEMo Chip and test strip lot numbers match. Never use a MEMo Chip from a
different lot than the test strip.
• Out-of-date or expired strips cannot be used in your test system. Check vial for expiration date.
• Add all of the blood to the test strip at once. If you do not get all of the blood on the strip, do not add
blood to the same strip. Test again with a new unused test strip and fresh blood sample.
• Discard test strip after using. Strips are to be read once. Never insert or read a used test strip.
•
Do not ingest.
SPECIMEN COLLECTION AND PREPARATION
PTS PANELS Test Strips are designed for use with fresh capillary (fingerstick) whole blood. Fresh
venous whole blood collected in EDTA or heparin tubes is also an acceptable sample. To obtain a drop
of blood from a fingerstick, follow the steps listed below:
• Use of lotions and handcreams should be avoided before testing.
• Hands should be washed in warm water with antibacterial soap, rinsed and dried thoroughly.
• If you wipe the fingertip with alcohol, be sure that the alcohol dries completely before sticking the
finger.
• Use a sterile, disposable lancet to puncture the side of the fingertip.
• Wipe away the first drop of blood with a clean piece of gauze.
• Gently, without force, apply pressure to the fingertip to accumulate a drop of blood.
• Excessive squeezing of the finger may alter test results.
• See the “TESTING” section for information on how to apply the blood to the test strip.
• Discard used materials properly.
Caution: Handle and dispose of all materials coming in contact with blood according to
universal precautions and guidelines.
TESTING
IMPORTANT: Read all instructions carefully before testing.
1. Insert the MEMo Chip that matches the lot number on the
test strip vial and press one of the buttons to turn the
analyzer ON.
2. Hold the test strip by the end with the horizontal raised
lines. Insert the opposite end of the strip into analyzer.
Push the strip in as far as it will go.
3. When APPLY SAMPLE appears on the display, use a
capillary blood collector or pipet to apply 15 µL of whole
blood to the test strip blood application window.
4. In about a minute, the result will appear on the display.
Remove and discard strip. DO NOT add more blood to a
test strip that has been used.
ADDITIONAL CONSIDERATIONS
1. If no result is displayed, make sure:
–Enough blood was added to the test strip to completely fill the blood application window.
–Analyzer is ON. (If it won’t turn ON, refer to analyzer User Guide section on changing
batteries.)
–MEMo Chip is properly installed in port.
2. If you get a reading of, “<___”, “ >___” or any
unexpected result, test again.
3. See analyzer User Guide Troubleshooting section
for additional help.
4. To verify enough blood has been applied to the test
strip, remove strip after testing and check back side
of reac tion area. Reaction area should be
completely and evenly colored. If the area is not
completely and evenly colored, discard the used
test strip and test again.
PTS PANELS
™
HDL Cholesterol Test Strips
for use with CardioChek
®
Brand Analyzers
PS-002657E Rev. 0 05/06
Manufactured by
Polymer Technology Systems, Inc.
Indianapolis, IN 46268 USA
CUSTOMER SERVICE (877) 870-5610 (toll-free inside the U.S.)
(317) 870-5610 Fax (317) 870-5608
Ribs that guide the strip into
the analyzer
Blood application window
Hold strip by this end.
Enough
blood
Examples of not
enough blood
Back of
Test Strip
