BS ISO 17822-2020 In vitro diagnostic test systems一Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens一- Laboratory quality practice guide.
4.3 Commercial equipment (including software programs)
Equipment intended to perform nucleic acid amplification-based examinations, including software programs necessary to perform the analysis, shall be installed, verified, calibrated and maintained according to the manufacturer’s instructions for use and documented laboratory procedures.
Where applicable, integration of laboratory instruments into existing IT infrastructure shall be verified.
EXAMPLE Connectivity to databases, hioinforniatic functions, etc.
If multiple instruments are potentially used for the same nucleic acid test, inter-instrument comparison shall be performed to ensure comparability of results. The laboratory shall verify any in-house developed interfaces between instrument components and shall also verify interfaces between instrument components developed by manufacturer.
4.4 Laboratory personnel
Personnel assigned to perform nucleic acid amplification-based examinations shall be qualified and trained to the level of competence required for the specific NAAT and pathogen including continuing education to maintain competency.
The qualification and training of these personnel shall be documented.
5 Planning and implementation of pathogen NAAT assay
In general the criteria of the design are listed in a design plan.
Design and development planning shall include:
1. Definition of user needs and stakeholder requirements
2. Definition of the intended medical use
3. Performance requirements and specifications and other design requirements and specifications based on the intended use
4. Product risk assessment
5. Assay design and assay component supplier qualification, this should include but is not limited to;
Specimen collection and processing, nucleic acid extraction, nucleic acid amplification, and detection and identification of nucleic acids of the target microbial pathogen, laboratory design, work flow and laboratory practices.
6. Performing of the feasibility phase
7. Verification and validation planning
8. Verification of design specifications
EXAMPLES Detection limit, cut-off values, analytical specificity (including cross-reactivity and interference), precision, carryover, linearity, and where appropriate, calibrator commutability and traceability of results to reference materials or reference measurement procedures.
9. Laboratory scale production process planning.BS ISO 17822 pdf download.