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Service laboratories point of view
Advantages
-
ISO standard
-Standardized protocols for pre-treatment, extraction, results interpretation
- Main matrices included
- Ease to set-up methods (protocol, list of reagents and equipment needed)
-Intercomparability, Ring trial efficacy
- facilitate accreditation
15
- Need a class 2 lab and people skilled in molecular biology
Drawbacks
Service laboratories point of view
- Methods very different from bacteria testing (several labs asked for practical
training + technical support)
- High cost to implement standardized virus methods
- Potential equipment change, leading to higher budget
- Numbers of controls (normative part)
- Long time to result
- Expensive analyses
- A limited number of matrices within the scope, hence difficulties for complex
ones (requests from service labs customers)
16
- Few manufacturers offering validated solutions
- ISO 17025 accreditation: difficult (depending on countries), cost effective
(several matrices, several viruses), ISO 16140 difficult to apply for viruses