Examples of Types of PTM Modification Validations

For example:  Original claim 3 matrices – 6 matrices will  be added bringing the total number of  matrices to 9, triggering an independent  laboratory study of two matrices (one  matrix previously tested and one new  matrix tested at the independent  laboratory).   Original claim 1 matrix – 5 matrices will be  added bringing the total number of  matrices to 6, triggering an independent  laboratory study of two matrices (one  matrix previously tested and one new  matrix tested at the independent  laboratory).   Reagent formulation of the amplification  reagent master mix  Addition or removal of a test step (for  example‐LFD step, second PCR step,  confirmation step or molecular verification  step) 

Inclusivity/Exclusivity, matrix comparison for subset of  claimed matrices and an independent laboratory study.  

Inclusivity/Exclusivity, matrix comparison for subset of  claimed matrices, and independent laboratory study. 

Table 2 details a summary of level 3 method modifications and the data requirements to  support the changes. Major modifications require substantial evaluation to ensure the modified  method still meets the method performance claims. Examples of major method changes are  changes to the enrichment protocol, addition of more than five matrices, change to a major kit  component, reformulation of master mix reagents and addition or removal of a test step. 

Reference Methods and Modifications 

Method modifications will utilize the most current reference method available regardless of the  reference method version used in the original validation study. 

Publication of Method Modifications