If it is not possible to demonstrat

If it is not possible to demonstrate the Linearity of the EZ-Fluo™ method across the complete range, it is possible to decrease the range and to demonstrate the linearity within a more narrow range(using four concentrations instead of the six series initially tested, for example).
If the Linearity does not meet one acceptance criteria, the corrective actions detailed in section 6.2.6 are applicable.
EZ-Fluo™ Method Range
The operational Range of the EZ-Fluo™ method is the interval between the upper and lower levels of microorganisms that have been demonstrated to be determined with Precision, Accuracy, and Linearity.
The effective range of the method is obtained from the effective CFU average observed at the lower and upper concentrations of the range tested.
The EZ-Fluo™ method range is compared to the traditional method range.
The Range can be determined on the basis of the Accuracy test results, once Precision, Accuracy and Linearity have been previously demonstrated.
In the example given in the Accuracy test, the theoretical test range tested(target concentrations chosen to perform the test)was from 5 to 100 CFU.
The effective range of the EZ-Fluo™ method is determined from the CFU average observed during handling:
Lower limit of the Range:at the lowest target concentration(corresponding to the theoretical concentration of 5 CFU)
Upper limit of the Range:at highest concentration(corresponding to the theoretical concentration of 100 CFU).
The table hereafter is an example of test results obtained during Accuracy tests:
EZ-FLUO™ ACCURACY RESULTS
TARGET INOCULUM CONCENTRATION
Fluo Counts,r:F, h
Control Counts(CFU)
Fluo Counts(CFU)
Control Counts
Series Replicate
Average CFU
On this example the range of the EZ-Fluo™ method is determined as follows:
Lower limit of the range:on the test series corresponding to the lowest concentration(theoretical 5 CFU)the lower limit of the EZ-Fluo™ method range is the calculated average count, rounded to the upper integer number(i.e. average=3.9, so lower limit of the range=4 CFU).
Finally, in this example and for the micro-organism tested, the range of the EZ-Fluo™ method is 4 to 103 CFU.
As the Range is based on the effective counts observed during the Accuracy test protocol, the acceptance criterion is that the Range is determined in conditions where Accuracy, Precision and Linearity have been verified.