From this link location
https://www.fda.gov/media/134922/download
As of 7-7-21 that link was still working. I expect they will remove it.
So here it is on Box
https://app.box.com/s/a1pfzuth6kyzjl3n7crtimmk645gaqph
Page 36
RNase P (Extraction Control)
All clinical samples should exhibit fluorescence growth curves in the RNase P reaction that cross the threshold line within 40.00 cycles (< 40.00 Ct), thus indicating the presence of the human RNase P gene. Failure to detect RNase P in any clinical specimens may indicate: −Improper extraction of nucleic acid from clinical materials resulting in loss of RNA and/or RNA degradation. −Absence of sufficient human cellular material due to poor collection or loss of specimen integrity. −Improper assay set up and execution. −Reagent or equipment malfunction.
No comments:
Post a Comment
Insightful and Relevant if Irreverent Comments