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AccuMeter Accuracy and Precision Independent Studies Bibliography and Excerpts

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 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:
"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:
"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 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 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 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 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 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:
"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. 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 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 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 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 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."

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