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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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