Intended Use

PTS PANELS CHOL+GLU Test Panel test strips measure total cholesterol and glucose in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipid metabolism disorders. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia and of pancreatic islet cell carcinoma. This test may be run by healthcare professionals and, under the guidance of a healthcare provider, individuals at home can measure their own cholesterol and obtain a glucose result at the same time. Those testing at home should use this product at the frequency that their doctor recommends testing for cholesterol. This does not replace a glucose meter.

SUMMARY

PTS PANELS CHOL+GLU Test Panel test strips measure total cholesterol, and glucose in whole blood with the CardioChek P•A Analyzer. 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 two minutes.

PRINCIPLES OF THE TEST

When blood is applied to a test strip, the blood reacts to produce color that is read by the analyzer using reflectance photometry. The amount of color produced is proportional to the concentration.

MATERIALS PROVIDED

• Vial of test strips and desiccant
• MEMo Chip (contains lot-specific test strip information)
• Instructions

MATERIALS NEEDED BUT NOT PROVIDED

• CardioChek PA analyzer
• Quality Control Materials
• Lancets for fingerstick (or venous blood collection supplies)
• Alcohol wipes and/or gauze
• Capillary blood collectors, capillary tubes or other precision pipet for blood collection and application

CHEMICAL COMPOSITION

Each CHOL+GLU Test Panel test strip contains the following active ingredients:

• Cholesterol Esterase (Microorganism) . . . ≥ 0.6 I.U.
• Cholesterol Oxidase (Microorganism) . . . ≥ 0.4 I.U.
• Peroxidase (Horseradish) . . . ≥ 1 I.U.
• 4-aminoantipyrine . . . ≥ 15 µg
• Substituted aniline derivatives . . . ≥ 20 µg
• Glucose oxidase (Aspergillus niger) . . . ≥ 0.2 I.U.
• N, N-disubstituted aniline . . . ≥ 15 µg

Each vial contains not more than 5g 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.
• CHOL+GLU Test Panel test strips can only be used in the CardioChek PA 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 one time. 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 and 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. Dispose of lancets in a closed container, such as a sharps container. 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 25-30 µL of whole blood to the test strip blood application window.

4. In about two minutes, the CHOL result will appear on the display. (To display GLU, press the (NEXT) button.) 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 reaction 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.

TEST RESULTS

Results are displayed in either milligrams per deciliter (mg/dL) or in millimoles per liter (mmol/L). The mg/dL measurement is a US version, while mmol/L is used in many countries around the world. The CardioChek PA is preset to US units by the manufacturer. No calculation of results is necessary. To change to INTL (mmol/L) units, please see CardioChek PA User Guide.

CALIBRATION AND QUALITY CONTROL

Quality Control tests are used to ensure that the total system (analyzer, strips, MEMo Chip) is working properly and that the test results are accurate and reliable within the limits of the system. Users should run controls at least monthly or with each new lot of test strips, when results are questionable or to comply with their own facility's quality control requirements. See the CardioChek PA User Guide for instructions on how to run controls. The CardioChek PA is factory calibrated before it is packaged. Use the Check Strip supplied to verify that the analyzer's electronics and optics are working properly. The Check Strip is NOT a Quality Control test. Please refer to the CardioChek PA User Guide for the proper procedure to be used to perform a Quality Control test.

EXPECTED VALUES

Cholesterol - The expected or reference ranges recommended are from the US National Cholesterol Education Program (NCEP) 2001 Guidelines₉ and are:

• Below 200 mg/dL (5.18 mmol/L) - desirable
• 200-239 mg/dL (5.18-6.20 mmol/L) - borderline to high
• 240 mg/dL (6.21 mmol/L) and above - high
• *CHD (Coronary Heart Disease)

The frequency of home cholesterol testing should be determined in consultation with your physician.

Glucose - Blood glucose levels will vary from time to time depending on food consumed, activity levels, health status, medication dosages, stress or exercise. Your physician or healthcare professional will discuss "target values" (that is, highs and lows) specifically appropriate for you. A glucose level below 50 mg/dL (2.78 mmol/L) or above 240 mg/dL (13.32 mmol/L) may indicate a serious medical condition. If your test result should fall below 50 mg/dL (2.78 mmol/L) or exceed 240 mg/dL (13.32 mmol/L), you should contact your physician or healthcare professional as soon as possible. Expected values are for a fasting person, who does not have diabetes are: 70-105 mg/dL (3.9-5.8 mmol/L).₆

MEASURING RANGE

CHOL+GLU Test Panel test strips will provide numeric results in the following ranges

Cholesterol: 100-400 mg/dL (1.3 - 10.36 mmol/L)

Glucose: 20-600 mg/dL (1.11 - 33.3 mmol/L)

Results below the range will read, "LOW" or "<___" (less than the measuring range). Results above this range will read, "HIGH" or ">___" (greater than the measuring range). IMPORTANT: If you get a result of "LOW", "<___" (less than), "HIGH", ">___" (greater than) or an unexpected result for any test, test again with a new unused test strip.

LIMITATIONS OF THE PROCEDURE

Studies were performed to test for substances that may interfere with these tests. The results are below.

1. PRESERVATIVES: Blood samples preserved with Fluoride or Oxalate should not be used for testing with this system. EDTA and Heparin do not interfere with the test. Fingerstick whole blood is the specimen of choice.

2. NEONATAL USE: This product has not been tested using neonatal blood. Until testing is done this test system should not be used on neonatal blood samples.

3. METABOLITES: Reducing substances such as Vitamin C may falsely decrease the cholesterol test result. This test system is specific for glucose. Other sugars and other reducing substances such as Vitamin C at normal blood concentrations have no significant effect on test results.

4. HEMATOCRIT: Hematocrit values above 55% and below 30% may incorrectly lower the glucose results. Hematocrits above 50% for lower than 30% may incorrectly lower the cholesterol results.

5. Bilirubin up to 20 mg/dL and hemoglobin up to 200 mg/dL do not interfere.

6. ALTITUDE: Testing at altitudes up to 5280 feet has no effect on glucose results.

7. DEHYDRATION: Severe dehydration and excessive water loss may produce falsely low glucose results.

PERFORMANCE CHARACTERISTICS

1. ACCURACY:

Cholesterol - Results from clinical studies comparing the PTS PANELS Test Strips to the Cholesterol Reference Method Laboratory Network (CRMLN) serum methods are listed below:

PTS PANELS Cholesterol vs. Abell-Kendall traceable method
n = 125 samples
range of samples tested: 125 to >400 mg/dL
y = 1.01x -1.83
r = 0.91

Glucose - PTS PANELS Glucose Test strip results are calibrated to provide plasma glucose values. The Glucose Test Strips were calibrated to an automated glucose hexokinase laboratory method run on plasma samples. In a method comparison to a leading commercially available glucose system (a biosensor glucose dehydrogenase method) that is calibrated to provide "plasma-like" values₅, the results below show that the PTS PANELS Glucose Test Strips compare well. This means that the PTS PANELS Glucose Test Strips should compare well to a laboratory plasma method:

PTS PANELS Glucose vs. Commercially Available Glucose System
Number of patients = 120
slope = 0.951
y-intercept = 5.36
r = 0.99

CHOL+GLU - The CHOL+GLU Test Panel test strips were run by professionals using a CardioChek P•A and the results were compared to results from PTS PANELS single analyte Cholesterol and Glucose Test Strips. The results were as follows:

Cholesterol Comparison
n = 112 samples
y = 0.895x +21.4
r = 0.905
bias at 200 mg/dL = +0.20%
bias at 240 mg/dL = -1.58%

Glucose Comparison
n = 113 samples
y = 1.017x -5.3
r = 0.986
bias at 80 mg/dL = -4.93%
bias at 126 mg/dL = -2.51%

The Chol+Glu Test Panel test strips compare well to the PTS PANELS Cholesterol and Glucose Test Strips.

2. PRECISION

Laboratory professionals tested two levels of whole blood for cholesterol and glucose using Chol+Glu Test Panel test strips. The following results were obtained:

Cholesterol
No. of Observations (n) 20 20 20
Mean Chol Conc. (mg/dL) 158.1 196.7 217.4
Std. Deviation (mg/dL) 9.1 11.7 8.1
Coefficient of Variation (%) 5.76 5.95 3.73

Glucose
No. of Observations (n) 20 20 20
Mean Glu Conc. (mg/dL) 44.8 59.0 249.5
Std. Deviation (mg/dL) 3.9 3.2 8.2
Coefficient of Variation (%) 8.71 5.42 3.29

3. INTERFERENCE

See Limitations Section.
CLIA INFORMATION (US only)
Complexity Categorization: Waived

REFERENCES

1. Data on file, Polymer Technology Systems, Inc., Indianapolis, IN 46268.
2. Clinical Diagnosis and Management by Laboratory Methods, Eighteenth Edition, John Bernard Henry, Editor,. W.B. Saunders Company, Philadelphia, 1991.
3. NCCLS Proposed Guideline EP6-P, Evaluation of the Linearity of Quantitative Analytical Methods. Villanova, PA: National Committee for Clinical Laboratory Standards, 1986.
4. NCCLS Tentative Guideline EP7-T. Interference Testing in Clinical Chemistry. Villanova, PA: National Committee for Clinical Laboratory Standards, 1986.
5. NCCLS Evaluation of Precision Performance of Clinical Chemistry Devices: Approved Guideline. 1999:19(2):1-48.EP5-A.
6. Tietz, NW: Textbook of Clinical Chemistry, W.B. Saunders Co., Philadelphia, PA 1986 pp. 1271-1279, 1821.
7. Young, DL, et. Al., Effects of Drugs on Clinical Laboratory Tests, AACC Press, Wash., D.C., 1990.
8. National Cholesterol Education Program 2001 Guidelines, National Institutes of Health, National Heart, Lung and Blood Institute, May, 2001.
9. ATP III NCEP Guidelines for CHD Risk. JAMA. 2001. 285:2486-2509.
10. Castelli, WP, et al. Circulation 1983. 67(4): 730-734.