ERP_MicrobiologyMethods_Meeting_Book_11-2022

ERP Meeting Book - November 2022

dLPOD (candidate vs. reference) f

0.00 (-0.03, -0.03) 0.03 (-0.01, -0.06)

0.00 (-0.03, 0.03) 0.00 (-0.02, 0.02)

0.04 (-0.07, 0.15)

dLPOD (candidate presumptive vs. candidate confirmed) f,g

0.01 (-0.01, 0.04)

a Results include 95% confidence intervals. b Repeatability standard deviation.

c Among-laboratory standard deviation. d Reproducibility standard deviation. e Both the alternative confirmation procedure and the confirmation procedure following the FDA BAM Chapter 5 produced identical results. f Confidence interval for dLPOD that does not contain the value 0 indicates a statistically significant

difference between the two methods. g Interlaboratory correlation coefficient

Table 2021.05B. Thermocycler heating steps Step

Temperature, °C

Time, min

1

37

10 minutes

2

95

5 minutes

3

10

2 minutes

4

4

Hold [1]