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The quality concepts of the Line Probe Assay (LPA) laboratory include:
- Infrastructure
- Dedicated areas for different steps of the procedure.
- Colour code/ label for different rooms:
- Red for pre-amplification area
- Green for DNA extraction area
- Blue for amplification area
- Yellow for post-amplification area.
- Unidirectional workflow for reduced risk of contamination. Under no circumstances should:
- Anything from the specimen preparation area be taken into the reagent preparation area
- Anything from amplification and hybridization/detection areas be taken into specimen or reagent preparation areas.
- Safety in the laboratory.
- Proper functioning instruments.
- Manpower
- Trained and competent staff.
- Maintained laboratory turn-around-time (sample receipt to reporting results).
- Documentation and Records: There is a need to have documents/records on the following:
- Standard Operating Procedures (SOPs)
- Laboratory Information Management System (LIMS): Worksheet, recording and reporting results
- Reagent manuals: Manufacturers’ instructions and specifications manuals
- Daily usage logs, corrective action logs, calibration, repair and maintenance records for instruments
- Safety aspects.
Quality Assurance including Quality Control (QC) includes:
Reagent QC: The following should be done:
- Testing of all lots of reagents
- Integrity testing upon receipt (e.g., Tag polymerase).
- Stock rotation
- Storage at the appropriate temperature
- Supply chain and inventory management.
- Expiry prevention
Equipment QC: This includes:
- Calibration
- Maintenance
- Validation
- Corrective actions for QC failures
- Knowledge to operate
- Service and repairs
- Manuals.
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