LPA Quality Assurance [QA] Including Quality Control

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.

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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.

Resources

• LPA Laboratory Manual, FIND, 2012.

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