How is the reference rage of an assay determined?
A) By testing 100-150 known standards and determining the range that runs from the lowest value to the highest value
B) By testing 100-150 specimens that represent the laboratory's patient population and determining the range that runs from 2 SD below the mean to 2 SD above the mean
C) By testing 100-150 specimens that represent the laboratory's patient population and ordering the values from lowest to highest with the lowest and highest values representing the range
D) None of the above
Question 2
How is the reportable range of an assay determined?
A) By calculating the standard deviation of known concentrations
B) By comparing the referent value to the number of false positives and false negatives
C) By establishing the nonparametric ranking of the data and using the lowest and highest points
D) By testing several specimens of known concentration that span the analytical range
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