Exploration of performance validation before transfer of immunohistochemical staining platform
ZHANG Shu-zheng
LÜ Yao-dou
ZHANG Xiao-juan
ZHANG Shan
ZUO Mei-lin
Abstract：Objective: To explore the performance verification process and experience of a new fully automated immunohistochemistry (IHC) staining platform before it is officially applied to clinical sample testing. Methods: Twenty antibodies were selected, and three cases with positive expression in IHC testing from the pathology department of Nanjing Kingmed Medical Laboratory Co., Ltd. in 2024 were chosen for each antibody. One paraffin section was re-cut for each case, resulting in a total of 60 slides, which were divided into first, second, and third verification groups. The new platform was used for testing, and the results were compared with those from the original platform. Results: A total of 60 different clinical cases were verified, with no false positives or false negatives observed. The positivity localization and quantity, clarity of positive staining, and non-specific background were all ≥95% compared to the standard slides. The integrity of the tissue was 100%, and the detection accuracy compared to the standard slides ranged from 95% to 100%. The consistency of three repeated staining verifications ranged from 95% to 99%. The new platform has 48 testing positions, with a verification coverage rate of 100%. Conclusion: The verification of 20 antibodies on the new platform met the expected target values for the three verification indicators, indicating that this platform can be applied to the testing of clinical samples for validated antibodies.
Keywords：IHC staining platform transferIHC performance verificationDetection accuracyProgrammable repeatabilityTesting position coverage
Publication Date：2025-04-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 457-460 )