Review Book

AOAC ERP Method Review Form

Submission Date

2020-03-04 10:31:29

Method Title:

Solus One Salmonella--Collaborative Study

Expert Reviewer Name

Thomas Hammack

E-mail Address

thomas.hammack@fda.hhs.gov

1. Is this method scientifically and technically sound?

Yes

2. Have sufficient controls been used, including those required to calculate the rate of false ‐ positive and false- negative results where appropriate? 3. Is sufficient information included for system suitability determination and product performance or acceptance testing? 4. Are the conclusions statements valid based upon data presented? 5. Do you agree that the evidence or data from this and previous studies support the proposed applicability statement? 6. Are there sufficient data points per product evaluated in accordance with AOAC requirements?

Yes

Yes

Yes

Yes

Yes

General Comments about the Method Scope/Applicability:

Scope and applicability match the PTM and MLV validation studies.

Pros/Strengths of the Manuscript:

Very well written. I wish that all of these manuscripts had a PTM data table in the Introduction.

Cons/Weaknesses of the Manuscript:

None observed.

Is the Validation Study Manuscript in a format acceptable to AOAC?

Yes