Verification of microbiological methods
Before an analytical method is taken into use, e.g. for routine testing, a laboratory must verify that it is capable of performing the analytical method. This includes evaluation of relevant performance characteristics to ensure that the method is fit for purpose within the laboratory.
NMKL procedure No. 32 provides guidelines on how
- a laboratory may verify that it is capable of performing an analytical method which has previously been externally validated
- a laboratory can evaluate the possibility of analysing additional matrices not covered by the primary validation, or include new matrices in the scope of an already verified method
- a laboratory should plan a verification and elaborate a verification report
The procedure is applicable to the verification of methods already validated properly in an interlaboratory study, and also to well-recognised standardised methods without validation and specified performance characteristics.
The procedure also describes how measurement uncertainty could be established while verifying the method, as the data obtained in the verification can be used in the evaluation thereof.