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Clinical Chemistry 38: 648-650, 1992;
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Clinical Chemistry, Vol 38, 648-650, Copyright © 1992 by American Association for Clinical Chemistry

Estimation of reference ranges: how many subjects are needed?

JA Lott, LC Mitchell, ML Moeschberger and DE Sutherland
Department of Pathology, Ohio State University, Columbus 43210.

We measured Na, K, Cl, glucose, hemoglobin, erythrocytes, and hematocrit in the serum or blood from approximately 800 male and 200 female second-year medical students in an effort to define the size of an acceptable reference population. Using the data from the men and Monte Carlo simulations of 10-400 samples, each carried out 5000 times, we found that for most of the above tests, approximately 200 people are required for stable lower (2.5%) and upper (97.5%) reference limits to be obtained. This agrees with the 198 subjects required by strictly statistical criteria to define the same limits with a 99% confidence level.


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