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The approximate linear range of each analyte is generally specified by the manufacturer or in the literature, but should be confirmed by each laboratory. If a linear relationship between analyte concentration and method response is not obtained, it will be impossible to report quantitative patient results by that method. If the linear range does not span the range of analyte concentrations generally expected in patient samples, the need for frequent dilutions may make the method too expensive and inconvenient. The linear range is determined by examining a plot of known analyte concentrations versus method response. Five samples of patient sera with concentrations extending from 0 to 1.5 times the range of routine analytic interest should be used. They should be spaced evenly throughout the range. Alternatively, dilutions of a high standard can be used to obtain a series of samples within the stated working range of the instrument. If a standard is used, it should be in the same matrix as the patient samples. Each sample should be prepared by direct dilution of the original high sample; serial dilutions should not be used because pipetting errors will be propagated through subsequent samples. Triplicate measurements should be made on each sample and the mean of the triplicates calculated. The means of each measurement should be plotted in an XY plot with the actual data points on the Y axis and expected values on the X axis. If the method is perfectly linear a straight line will be obtained that will have a slope of 1.00 and Y intercept of zero. The slope is an indicator of the % recovery; if the slope is 0.94 then recovery is 94%. Linearity can be accepted if the slope is 1.00 +/- 0.03 and the Y intercept is 0 +/- the within run precision. Alternatively, the method can be considered linear if there is less than 10% variance between observed and expected values at each level. Nonlinearity should be suspected if the percent differences for the highest and lowest concentrations have one sign (e.g. positive number) and the intermediate levels have the opposite sign (e.g. negative number). |
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