Multicenter Evaluation of a Patient-Administered Test for Blood Cholesterol Measurement

Background.In order to assess accuracy of a newly developed, noninstrumented, self-administered fingerstick test that measures cholesterol levels in whole blood, the AccuMeter Cholesterol Self-Test was evaluated for home-use by untrained consumers in a multicenter study.Methods.A total of 486 untrained adult volunteers of varying age, occupation, and educational background were recruited at four sites. Participants received written instructions provided in the kit, access to a telephone “800” number for additional help, and, if necessary, a short instructional video available to consumers on request. Fingerstick cholesterol results obtained by untrained volunteers were compared with paired venous serum results obtained by the Abell–Kendall cholesterol reference method. After application of exclusion criteria, 79.0% (384/486) of subjects had AccuMeter fingerstick results available for comparison with the reference method.Results.Results obtained with the AccuMeter test correlated well with the Abell–Kendall results (r= 0.91). There was a mean overall bias for the AccuMeter of −0.116 ± 0.528 mmol/liter (−2.2%), with a mean absolute bias of 0.398 ± 0.367 mmol/liter (7.6%). Biases at the National Cholesterol Education Program cutpoints of 5.20 and 6.20 mmol/liter were −2.2 and −2.5%, respectively. Subjects with high-risk total cholesterol values (≥6.20 mmol/liter) were correctly classified 80.0% of the time, with an additional 18.8% placed in the borderline category (5.20–6.20 mmol/liter); 1.2% were inappropriately placed in the desirable category. No subjects were placed in the high-risk category by the AccuMeter test if they had a desirable cholesterol value by the reference method, while 9.8% were placed in this category if they were in fact borderline.Conclusions.This test appears to be a useful addition to available options in the effort to increase awareness of cholesterol as a heart disease risk factor. A large portion of untrained consumers were able to perform the AccuMeter Cholesterol Self-Test and obtain comparable results to the reference method. This test for the first time allows consumers to determine their own cholesterol values, with a reasonably good degree of accuracy.