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]
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