BRIEFING

 〈77〉 Mycoplasma Nucleic Acid Amplification Tests. A previous proposal for this new chapter was published in PF 48(5) [Sept.–Oct. 2022]. That proposal has been canceled and is being replaced by this updated version, which includes the following revisions by the Microbiology Expert Committee:

1. Rewrite the Introduction to state that the chapter is intended to be used for the validation and testing of qualitative nucleic acid amplification tests (NATs) for the detection of Mycoplasma contamination.

2. Reorganize Table 1 based on the applications.

3. Add a section to provide guidance on Primary Method Validation.

4. Change the requirements in the Method Suitability Test as follows:

   1. Include the inoculation of test microorganisms at not more than 10 colony-forming units/mL (CFU/mL) or not more than 100 genome copies/mL (GC/mL).

   2. Include the use of three test strains defined in the application as specified in Table 1.

   3. Remove the specification for the Sample volume.

5. Clarify the definition of Quality Controls used for testing and provide a summary of assay controls in Table 2.

6. Remove the subsection "Investigation of Invalid Results".

 (GCM: H. Tu)

 Case ID—SUB-516