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Beyond PBMCs: Polymer-Based Cell Mimics for Robust TBNK Immunophenotyping Assay Validation.

Swetha Pratyusha Gunturu1, Subhanip Biswas1, Armando Martinez1

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Cytometry. Part a : the Journal of the International Society for Analytical Cytology
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Summary

Synthetic TBNK Cell Mimics offer stable, lot-consistent controls for flow cytometry immunophenotyping assays, reducing variability in research and diagnostics. These polymer-based mimics provide reliable performance for assay validation and routine quality monitoring.

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Area of Science:

  • Immunology
  • Biotechnology
  • Analytical Chemistry

Background:

  • Flow cytometry TBNK immunophenotyping is crucial for immune assessment but faces challenges with biological control variability.
  • Donor differences, limited stability, and antigen expression fluctuations in materials like PBMCs hinder consistent assay performance.

Purpose of the Study:

  • To analytically validate TBNK Cell Mimics as standardized reference controls for TBNK immunophenotyping assays.
  • To assess the performance of synthetic cell mimics in improving assay consistency and reliability.

Main Methods:

  • Comprehensive analytical validation of a TBNK immunophenotyping assay using TBNK Cell Mimics.
  • Evaluation of parameters including repeatability, precision, accuracy, linearity, specificity, robustness, stability, and carryover.
  • Accelerated stability studies at 25°C and 37°C.

Main Results:

  • TBNK Cell Mimics met all acceptance criteria, showing ≤5% CV for precision and R² >0.998 for linearity.
  • Stability studies demonstrated <5% variation in population frequencies, confirming suitability for quality monitoring.
  • Synthetic controls provided consistent and reproducible performance.

Conclusions:

  • TBNK Cell Mimics serve as a consistent and reproducible reference material for assay validation and routine performance assessment.
  • These synthetic controls help reduce technical variability and improve harmonization across different testing environments.
  • While not replacing biological samples for specific analyses, they offer a practical tool for enhancing assay reliability.