Microbiology-PTM-OMA_Modules_1-5

Analyzing Data – Qualitative Method MLV

• First, analyze data from each laboratory and each material individually for POD CP , POD CC , POD C ,  and POD R . • Calculate dPOD CP , and dPOD C with appropriate confidence intervals (paired or unpaired) for each  laboratory and each material. • Look for any statistically significant differences • Combine data across laboratories and calculate LPOD CP , LPOD CC , LPOD C , and LPOD R with 95%  confidence intervals. • Determine error estimates s r , s L , and s R and report with 95% confidence intervals. • Determine the p ‐value of the T test based on the X 2 distribution and compare to 0.10 to  determine whether the interlaboratory effect, s L , is statistically significant. This is the  homogeneity test of laboratory POD values. • Finally, determine dLPOD CP and dLOPD C with appropriate confidence intervals (paired or  unpaired) for each material. • In the text of the report, include the false positive and false negative rates for the comparison of  candidate method presumptive and confirmation results across all laboratories.