Figure 4.

Intermediate Precision Testing

The Mycoplasma Detection Assay was run on samples multiple times to demonstrate the reliability of the assay. (A and B) Run 2 in-process samples were tested by operator 1 (A) and operator 2 (B). (C and D) Run 4 drug product samples were tested twice by operator 1 (C [round 1] and D [round 2]). Lane 1, positive control: 18 GC M. arginini or 107.2 GC M. hominis; lane 2, positive control: 1,800 GC M. arginini or 10,720 GC M. hominis; lanes 3–5 and 11, M. arginini or M. hominis spike-test controls; lane 6, blank; lanes 7, 8, and 10, test sample; lanes 9 and 12, negative control; lane L, ladder; lane B, blank. Mycoplasma-specific expected band size was 400–500 bp; β-actin was 250 bp.