Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays

Area of Science:

• Biotechnology
• Immunology
• Clinical Diagnostics

Background:

• Luminex bead array assays enable high-throughput quantification of numerous biomarkers.
• A lack of standardized proficiency testing has hindered consistent performance in laboratories using these assays.

Purpose of the Study:

• To develop and implement a Luminex assay proficiency testing program.
• To assess and improve the performance of laboratories conducting Luminex assays.

Main Methods:

• A collaborative effort established an External Quality Assurance Program Oversight Laboratory (EQAPOL).
• Proficiency panels with specific cytokine standards and spiked serum samples were distributed annually.
• A scoring system evaluated timeliness, protocol adherence, accuracy, and precision.

Main Results:

• Overall proficiency scores remained stable across three testing rounds (75-77%).
• Significant improvements were observed in both intra- and inter-site variation.
• Training and remediation appear to positively impact laboratory performance.

Conclusions:

• The developed proficiency testing program is effective in monitoring and improving Luminex assay performance.
• Continued testing will help identify variables affecting assay outcomes and promote standardization.
• This initiative strengthens efforts towards reliable biomarker quantification in diverse laboratory settings.