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Using an
alternative methodology for the detection of Mycoplasma requires validation
and demonstration of comparability to reference standards. A PDA Task Force
of experts has developed the PDA Technical Report No. 50, Alternative Methods
for Mycoplasma Testing to help your analytical lab feel confident in the use
of alternative methods.
The report
focuses on non-culture testing methodology, including Nucleic Acid Amplification
Technique (NAT) assays and enzyme activity based assays. Representatives of the
U.S. FDA and the U.S. Pharmacopeia contributed to the report. The report provides
information about existing assays and compendial Methods like NAT based methods
and non Nat based methods and describes assay procedures, validation of assays,
comparability with reference methods and possible applications.
You can also
order the
Technical Report. |
