Stanford University and Palo Alto YMCA Cardiac Rehabilitation: "A total of 251 patients with broad demographic diversity of age, gender, and cholesterol values were included in the
study ... When CholesTrack AccuMeter was compared to Abell-Kendall ... the correlation coefficient was 0.96, and the
maximum
estimated bias did not exceed 1%."
Superko R, Berra K, Rudd C. Alternate site monitoring of blood cholesterol. Oral presentation at the national
conference on cholesterol and high blood pressure control. Washington, DC, 1991
University of Maryland: "CholesTrack
AccuMeter
demonstrated average bias less than 3%."
Gregory LC, Duh SH, Christenson RH. An evaluation of total cholesterol
measurements by desktop analyzers. Accepted for presentation at the 44th
National Meeting of the American Association for Clinical Chemistry, July 19-23,
1992. Chicago IL
Pacific Biometrics
Laboratories: "CholesTrack
AccuMeter
... performance is quite good with reported CVs in the 4-5% range and
acceptable accuracy on fingerstick whole blood compared with the Abell-Kendall
reference method."
Warnick GR. Compact analysis systems cholesterol, triglycerides and high density
lipoprotein cholesterol. Current Opinion in Lipidology 1991:2:343-8.
University of Virginia: "Samples
were collected from 100 ambulatory donors (and) accuracy was evaluated by
comparison to the venous plasma results from a CDC standardized enzymatic
cholesterol (method). Average bias for total cholesterol was within +
2. 1 %."
Miller G. Performance of generation total and HDL cholesterol compact
measurement systems. Accepted for poster publication at the 1992 National
Meeting of the American Association for Clinical Chemistry, July 1923. Chicago
IL
University Hospital, Nantes,
France/Milan Italy: "Accuracy
was good, with a high correlation with the reference method (Bias -2% at 150
mg/dL, -1% at 200 mg/dL, -0.4% at 249 mg/dL)."
Pezzo M Luraschi P, Ceriotti F, Bonini PA, Truchaud A,. Evaluation of a
non-instrumented quantitative test system for cholesterol determination.
Abstract presented at ATB '92 satellite meeting, Milan Italy. 1991
Palo Alto Cardiac
Rehabilitation: "TCHOL
levels ranged from 123-372 mg/dL ... both the CholesTrack AccuMeter and the Abell-Kendall
gave similar risk assessment for CHD."
Rudd C, et al. Self-testing of blood cholesterol. Paper presented at World
Congress of Cardiac Rehabilitation. Bordeaux France. 1992
ChemTrak Research
Laboratories: "The
CholesTrack AccuMeter Cholesterol test provides accurate, quantitative results on FS (fingerstick)
blood comparable to the Abell-Kendall reference method on venous serum."
Ammirati, E, et al. Chemical evaluation of fingerstick sampling vs. venous blood
sampling in total cholesterol measurements. Abstract accepted for presentation
at the 44th National Meeting of the American Association for Clinical Chemistry,
July 19-23, 1992. Chicago IL
Hampshire Pediatric, Manchester
New Hampshire: "The
CholesTrack AccuMeter ... produce(s) precise and accurate measurements that fall within
the 3% to 5% CV and analytic bias values established by the NCEP."
Schuman AJ A guide to office cholesterol testing. Contemporary Pediatrics 1991;
8:17-42.
ChemTrak Research
Laboratories: "When
the CholesTrack AccuMeter was compared against the in-house Boehringer Mannheim High
Performance Assay 'results for 74 patients' samples shows... a correlation
coefficient of 0.97."
Allen MPI DeLizza A, Ramel U, Jeong H, Singh P. A non-instrumented quantitative
test system and its application for determining cholesterol concentration in
whole blood. Clin Chem 1990, 36:1591-6
SAMLS Singapore Association
for Medical Laboratory Sciences: "The
CholesTrack AccuMeter Cholesterol correlates well with our established laboratory method
(Kodak Ektachem) (r = 0.9497). The availability of such a rapid cholesterol
procedure might facilitate the diagnosis of patients with lipid disorders."
Yuen Mark CS, Aw TC. A rapid non- cholesterol assay. Abstract accepted for
poster publication at the 3rd Scientific Meeting, Singapore. November 15, 1992.
ChemTrak Research
Laboratories: "CholesTrack
AccuMeter
technology is feasible for the quantitative measurement of HDL cholesterol. We
plan to continue optimizing this instrument-free prototype type for whole blood
HDL so that it can be tested in a multiple-site clinical evaluation in the near
future. We also expect to continue expanding this technology measure a wide
range of analytes with clinical interest, including immunoassays of
disease-associated markets." Victor YS Liu, Tayyean Lin, Wayne Schrier, Michael Allen and Prithipal
Singh. CholesTrack AccuMeter(R) non- quantitative assay of high-density lipoprotein in whole
blood. Clin Chem 1993; September 1993.
Institute of Medical &
Veterinary Science, Adelaide South Australia: "By
measuring venous blood cholesterol levels on the CholesTrack AccuMeter and following the
manufacturer's instructions for collecting the fingerstick blood, we also showed
that there was no significant difference between venous and capillary blood. Our
results show that the CholesTrack AccuMeter cholesterol method is suitable for assessing
blood cholesterol levels."
Susan Branford, Renze Bais, Jane L. Hosking, Stan K. Sobecki and Erika B.
Ammirati. Evaluation of the CholesTrack AccuMeter(R) cholesterol method: comparison with a
CDC standardized method Abstract accepted for poster publication at the 1993
IFCC Congress Secretariat-Main Congress. November 14-19, 1993, Melbourne
Australia
United States FDA: In the FDA
clearance of CholesTrak for consumer use, Dr. David Kessler, former
Commissioner of the FDA, stated, "Accuracy is crucial. It is also
important, as the study showed, that participants were able to read and
understand the instructions and perform the test without assistance."
United States Health and
Human Services: Perhaps the
best summary of the value of the CholesTrack AccuMeter Home Cholesterol Test in the current
healthcare environment came from Donna Shalala, Secretary of Health and Human
Services, "this test can help give consumers greater opportunity to monitor
their health and take steps to prevent disease. Making it more convenient to
check on cholesterol can help ensure that people are aware of the level so they
can see a doctor before serious problems develop."
