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 (> or = 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.