OMA Consulting Protocol Review: OMACON-2019-2

2.6

Robustness Evaluation

The idea for the robustness testing is to deliberately introduce minor, reasonable variations in a test kit method and observe the effects. These minor variations should be of a magnitude that might well be expected to occur when the test kit is used by an end user. If the results are altered, test kit users should be warned not to depart by more than some stated amount from the specified conditions. Presumably most of these variations will show negligible effects, but manufacturers and users benefit if just one sensitive condition is determined, and users are appropriately warned. The kit manufacturer is expected to make a good faith effort to determine which parameters are most likely to affect the analytical performance and determine the range of variations that can occur without adversely affecting analytical results. These recommended factors for robustness testing are based on the technical materials provided by Biolan Microbiosensors. AOAC INTERNATIONAL recommends testing the following operational parameters:

Table 6. Robustness Parameters Parameter Designation A. Sample Pre -Treatment Time

Value 1 20 min 1.8 mL 1.8 mL

Value 2 30 min 2.0 mL 2.0 mL

Value 3 40 min 2.2 mL 2.2 mL

B. Sample Volume

C. LAC1 volume during calibration

Table 7. Factorial Design for Robustness Testing Treatment Combination A

Parameter Value

B

C

1 2 3 4 5 6 7

20 min 20 min 20 min 20 min 40 min 40 min 40 min

1.8 mL 1.8 mL 2.2 mL 2.2 mL 1.8 mL 1.8 mL 2.2 mL

1.8 mL 2.2 mL 1.8 mL 2.2 mL 1.8 mL 2.2 mL 1.8 mL

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