What process is most appropriate to establish a reference range for a new analyte independent of race and gender?

The most appropriate process to establish a reference range for a new analyte independent of race and gender involves determining the central 95th percentile from a large sample. This method is favored because it provides a robust statistical basis for defining the reference range by capturing a broad representation of the population.

When using a large sample size, the variability of the analyte in the general population can be accounted for more effectively. By determining the central 95th percentile, you can exclude outliers and ensure that the established reference range reflects a significant segment of the population, rather than being skewed by extreme values. This approach helps to create more reliable and applicable reference ranges across diverse demographics, thus minimizing the influence of race and gender differences.

Other methods, such as calculating ±2 standard deviations from a small sample, may not adequately capture the true variability of the analyte in the broader population. Similarly, using only the lowest and highest values from a small sample does not account for the distribution of values and increases the risk of including non-representative outliers. Calculating the mean from healthy and affected individuals also fails to provide a clear reference range, as it does not focus solely on healthy individuals nor appropriately manage the variability inherent in different populations.