[Six Sigma driven QC management in hepatitis C serology]

Area of Science:

• Clinical Laboratory Science
• Immunology
• Infectious Diseases

Background:

• Westgard quality control (QC) rules are standard in infectious diseases serology.
• Optimizing QC requires balancing error sensitivity and false rejection rates.
• The six sigma methodology offers a framework for robust QC management.

Purpose of the Study:

• To illustrate the six sigma methodology in QC for the anti-HCV Architect test.
• To identify key factors influencing sigma value in serological assays.
• To develop an optimal QC strategy for infectious diseases serology.

Main Methods:

• Utilized 6 months of data from low positive and in-kit control materials with four reagent kits.
• Calculated test precision to determine the error budget.
• Applied the six sigma methodology to assess test performance.

Main Results:

• Achieved sigma values greater than 6, indicating a low error rate (4 erroneous results per million tests).
• The six sigma concept supported the adoption of a new QC strategy (13S rule with one positive control).
• Existing QC rules were relaxed based on the six sigma evaluation.

Conclusions:

• The six sigma methodology provides a framework for evaluating test performance in infectious diseases serology.
• An optimal QC strategy can be designed using the six sigma concept.
• This approach enhances quality requirements and test validation in clinical laboratories.