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Virus : detection method?
CEN/TC275/WG6/TAG4
ISO/TS 15216
Part 1 & 2
CONTROLS
Reproducible & Repeatable
Several levels of controls
Use of a
tracer
(mengo virus vMC0)
Internal Control integration + (
IPC
)
ANALYSIS
COMPLEX
METHODS
EXTRACTION
EFFICACY
RT-PCR
7
Done with Plasmides
Control
+
(Virus deactivated or plasmides)
for pre-treatment, extraction & RT-PCR
EFFICACY
QUANTIFICATION
RT-PCR
NEGATIVE
CONTROLS
Virus : detection method?
CEN/TC275/WG6/TAG4
ISO/TS 15216
Part 1 & 2
Shelf Life : 12 Months
8
Comply to ISO/TS