TEST RESULTS
Results are displayed in either milligrams per deciliter (mg/dL) or in milli moles per liter (mmol/L). The
mg/dL measurement is a US version, while mmol/L is used in many countries around the world. The
analyzer is preset to US units by the manufacturer. No calculation of results is necessary. To change to
INTL (mmol/L) units, please see the analyzer User Guide.
QUALITY CONTROL
Please refer to the analyzer User Guide for the proper pro cedure and materials to be used to perform
Quality Control tests. Quality Control tests are used to ensure that the system (analyzer, strips, and
MEMo Chip) is working properly. Users should run controls when results are questionable or to comply
with their own facility’s quality control requirements.
EXPECTED VALUES
Blood cholesterol levels will vary from time to time depending on food consumed, activity levels, health
status, medication dosages, stress or exercise.
The expected or reference ranges recommended are from the US National Cholesterol Education
Program (NCEP) 2001 Guidelines and are:9
•40 mg/dL and below (1.04 mmol/L) - Low (increased risk for coronary heart disease)
• 60 mg/dL and above (1.55 mmol/L and above) - igh (decreased risk of coronary heart disease)
A healthcare professional will discuss values that are specifically appropriate for each patient.
ALWAYS CONSULT A EALT CARE PROFESSIONAL BEFORE MAKING ANY C ANGES IN
TREATMENT PLANS OR MEDICATION.
MEASURING RANGE
The DL cholesterol test system will detect DL levels from 25-85 mg/dL (0.65-2.20 mmol/L) and will
display a number value for results in this range. If the display reads “<___” (less than measuring range),
the DL cholesterol level is below 25 mg/dL (0.65 mmol/L). Results above 85 mg/dL (2.20 mmol/L) will
read “ >___” (greater than measuring range). If a “ < ” or “ > ” result is displayed, always test again.
At least two measurements of DL Cholesterol on sepa rate occasions should be made before a
medical decision is made, since a single reading may not be representative of a patient’s usual DL
Cholesterol concentration.
This test does not replace a lipid panel run by a laboratory. Never make any medical decisions based
on your results. Always contact your healthcare professional for advice.
LIMITATIONS OF THE PROCEDURE
1. PRESERVATIVES: Blood samples preserved with Fluoride or Oxalate should not be used for
testing with this system. EDTA and eparin do not interfere with the test. Fresh 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 test result.
4. Bilirubin up to 10 mg/dL and hemoglobin up to 750 mg/dL do not interfere. Triglycerides up to
1000 mg/dL do not interfere.
5. EMATOCRIT: ematocrit values above 49% may incorrectly lower the test result and below
33% may incorrectly increase the test result.
6. DRUGS: Both dopamine and α-methyldopa interfered at all levels tested starting at levels of
1.75 mg/dL for dopamine and 0.625 mg/dL for α-methyldopa.
PERFORMANCE CHARACTERISTICS
1. ACCURACY:
In a two-site clinical study, correlation was established between a new modified test strip and a
previous formulation of the test strip. DL cholesterol of forty (40) subjects was measured on
both the new and the previous test strip formulation. The results for the comparison follow.
PTS PANELS DL Cholesterol New vs. Original
Number of patients = 40
Range of patient results: 29 to 83 mg/dL
slope = 0.835 y-intercept = 5.6 r = 0.96
Bias at 40 mg/dL = -1.0 mg/dL
The following three studies were performed using the original test strip formulation to which the
new test strip was compared above.
A professional clinical study was performed at three sites. DL cholesterol levels were measured
on fresh capillary blood specimens from 88 persons by healthcare professionals. The DL
Cholesterol Test Strips were compared to results from an automated DL method.
PTS PANELS DL Cholesterol vs. Automated Method
Number of patients = 88
Range of patient results: <25 to >85 mg/dL
slope = 1.1 y-intercept = -4.1 r = 0.89
Bias at 35 mg/dL = -0.2 mg/dL
In another study, the DL Cholesterol Test Strips were run by professionals on 87 patients from
four sites and results compared to those run on the same patients by the Abell-Kendall method in
a Cholesterol Reference Method Laboratory Network (CRMLN) laboratory. The results were:
PTS PANELS DL Cholesterol vs. Abell-Kendall Method
Range of patient results: <25 to 80 mg/dL
Slope = 0.85 y-intercept = 2.2 r = 0.85
bias at 35 mg/dL = -3.1 mg/dL
In a consumer study eighty-seven (87) consumers tested their DL cholesterol with the PTS
PANELS DL Test Strips. These consumer results were compared to a reference DL method
that is recommended by the Centers for Disease Control (CDC).
None of the consumers’ results in this study indicated their DL cholesterol was 35 mg/dL or
greater when their DL was below 35 mg/dL by the reference method. About 28% of consumers
in this study who tested their own DL one time obtained results less than 35 mg/dL when their
DL was 35 mg/dL or higher by the reference method. When the test was repeated, this rate
improved to 16%. This means that when you test your own DL, you may at times get results
below 40 mg/dL when your results are actually above 40 mg/dL. Duplicate testing is especially
important to confirm results below 40 mg/dL.
2. PRECISION: A laboratory professional tested twenty replicates of three levels of whole blood for
DL cholesterol. The following results were obtained:
No. of Samples 20 20 20
Mean DL Cholesterol Conc. (mg/dL) 36.4 45.5 65.0
Std. Deviation (mg/dL) 1.67 2.56 4.73
Coefficient of Variation (%) 4.59 5.63 7.28
Two lay persons tested blood at two levels of DL cholesterol with the following results:
Lay person 1 Lay person 2
No. of Samples 20 20 20 20
Mean DL Cholesterol Conc. (mg/dL) 45.8 69.4 45.2 64.3
Std. Deviation (mg/dL) 2.73 5.06 2.95 3.34
Coefficient of Variation (%) 5.97 7.29 6.52 5.19
This means that results should not vary more than about 8%.
3. INTERFERENCES: See LIMITATIONS section.
AVAILABILITY
REF/CAT NO. DESCRIPTION
1714 PTS PANELS DL Cholesterol Test Strips – 25 Tests
1715 PTS PANELS DL Cholesterol Test Strips – 6 Tests
1788 PTS PANELS DL Cholesterol Test Strips – 3 Tests
730 / 1709 CardioChek Analyzer
1708 CardioChek P•A Analyzer
722 PTS PANELS DL Cholesterol Controls – Level 1 & Level 2
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 enry, 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. National Cholesterol Education Program. Report of expert panel on detection, evaluation, and treatment of high
blood cholesterol in adults. National eart, Lung and Blood Institute, NI , Bethesda, MD, Arch. Int. Med.,
148:36-69 (1988).
6. NCCLS. User evaluation of precision performance of clinical chemistry devices: tentative guidelines.
1984:2(1):1-48.EP5-T.
7. National Cholesterol Education Program. ATP III Guidelines At-A-Glance Quick Desk Reference. National
Institutes of ealth. National eart, Lung and Blood Institute. NI Publication No. 01-3305, May 2001.
CUSTOMER SERVICE
Customer Service is available to answer questions regarding the CardioChek brand analyzers and
PTS Panels Test Strips. Outside Customer Service hours, please contact your healthcare professional.
(877) 870-5610 (8 a.m. – 5 p.m. EST, M-F toll-free inside the USA)
(317) 870-5610, FAX 1 (317) 870-5608
E-mail inforequest@cardiochek.com
© 2006 by Polymer Technology Systems, Inc.
The CardioChek brand analyzers and PTS PANELS Test Strips are manu fac tured in the US by
Polymer Technology Systems, Inc., Indianapolis, IN 46268 USA.
AUT ORIZED EUROPEAN REPRESENTATIVE
per IVDD 98/79/EC
MDSS Gmb
D-30163 annover, Germany
Explanation of Symbols
Use By/Expiration date
Batch Code/Lot number
For in vitro diagnostic use
This product fulfils the requirements
of Directive 98/79/EC on in vitro
diagnostic medical devices.
Catalog number
Consult instructions for use
Manufacturer
Store at/Temperature limitation
0197
0197
