Summary:
All percent recovery amounts are within the acceptable range of 95% to 105%. This
indicates that the instrument is sensitive enough to detect an acceptable amount of analyte
of interest without too much interference.
The interference study was performed to estimate the systematic error that maybe be
present when a specimen is analyzed. According to CLIA the total allowable limit is +/-
15% for WBCs. The interference was not significant enough for samples to be rejected.
The average from the spiked results were within the acceptable range of +/- 15%. The
average interference in this study is -7.0%, which is less than the CLIA acceptable error.
Therefore, there is no interference and will not cause a constant systematic error in the
method.
A method comparison study was performed to determine if there is a difference in WBC
count between the CD3500 and CD3200. When all data were plotted into a graph, the
correlation coefficient was >.95. As a result, according to CLIA acceptable correlation
coefficient being 0.95-1.05, the two instruments have strong correlation. The intercept was
less than .05, showing that there is no noticeably constant error (bias). The p-value is less
than 0.05; therefore, I can reject the null hypothesis that there is a difference between the
two instruments.
The CLIA allowable limit for our analyte is %15. The within run study for the old
instrument had an allowable error that was less than the standard deviation, therefor
resulting in a rejecting of the results. The allowable error for the between run for the old
