Appendix C
SMILE Example of a PCR Reagent Lot Validation Form
PCR Test/Kit: __________________________ Manufacturer:__________________
Date: ___________________________
Old Kit:
Lot number:_______________________ Expiration Date: _____________________
New Kit:
Lot Number: _____________________ Expiration Date:_______________________
Test the new kit lot numbers by repeating three patients (negative, low positive, high
positive) on the new lot number and the old and new controls - document the results
using the table below
Sample ID
OD
Results of Old kit
Viral
Interpretation
Load
OD
Results of New Kit
Viral
Interpretation
Load
Comments
Acceptance Criteria:
_____________________________________________
Reviewed by: ________________________ Position:______________________
Date: _____________________
(This worksheet is an example and should be modified to fit the needs of individual labs )
Parallel Testing
1
Appendix C
Initials