A nonlinear component of the analytical error

Background In clinical chemistry, a number of studies shows that the probability of very large errors is much greater than expected from the Gaussian distribution. In addition, it has been empirically found that the behavior of nonlin-ear complex systems is often asymptotically exponential. Consequently, we may assume that the error of some analytical systems may be approximated by the sum of a linear component of error with Gaussian distribution and a nonlinear component with Laplacian. Then, the probability density function (pdf) of the total error is approximated by the convolution integral of the Gaussian and the Laplacian pdf. Methods To explore the assumption of a nonlinear component of the analytical error I have evaluated this distribution and calculated various quality control related statistics with numerical methods. Results Large errors are much more probable with the proposed distribution than with the Gaussian. Simulated series of measurements with the proposed distribution often meet the criteria for normality. The critical errors and the probabilities for critical error detection are less than the respective ones of the Gaussian distribution. The probabilities for false rejection are greater. Conclusion To optimize the quality control planning process, we should explore the possibility that there exists a nonlin-ear component of the analytical error.