Application of the PDCA cycle in companion diagnostic PD-L1 SP263 immunohistochemical testing

BMC Cancer. 2025 Jul 12;25(1):1167. doi: 10.1186/s12885-025-14572-4.

Abstract

The aim of this study was to investigate application of the PDCA (Plan-Do-Check-Action) cycle in companion diagnostic PD-L1 SP263 immunohistochemical (IHC) testing. By using scientific quality control methods, the accuracy and consistency of the experimental results were ensured.Methods A total of 279 cases of PD-L1 SP263 IHC testing conducted in our hospital from May 2021 to December 2021 were collected. The PDCA cycle method was applied, and quality control data before and after its implementation were analyzed and compared.Results The application of the PDCA cycle effectively strengthened quality control management that significantly improved the accuracy and consistency of PD-L1 SP263 IHC testing results.Conclusion PD-L1 SP263 testing has value as both a complementary and companion diagnostic test for immunotherapy in malignant tumors, with the accuracy of its results being particularly crucial. The testing process involves pre-analytical, analytical, and post-analytical phases. The application of the PDCA cycle provides a robust scientific approach to aid quality control management throughout the PD-L1 SP263 testing process.

Keywords: Immunohistochemical testing; Immunotherapy; PDCA cycle; Quality control.

MeSH terms

  • B7-H1 Antigen* / analysis
  • B7-H1 Antigen* / metabolism
  • Biomarkers, Tumor* / analysis
  • Humans
  • Immunohistochemistry* / methods
  • Immunohistochemistry* / standards
  • Neoplasms* / diagnosis
  • Neoplasms* / immunology
  • Quality Control

Substances

  • B7-H1 Antigen
  • CD274 protein, human
  • Biomarkers, Tumor