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Updated: Nov 21, 2025
Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
Published on: September 25, 2018
Clinical evaluation of a laboratory-developed test using clone E1L3N for the detection of PD-L1 expression status in
Hanyan Xu1, Xidan Dong2, Hanxin Zhao1
1The Key Laboratory of Interventional Pulmonology of Zhejiang Province, Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Background:
Programmed death ligand 1 (PD-L1) has been used as a diagnostic marker to identify patients that will benefit from immune checkpoint inhibitors in non-small cell lung cancer (NSCLC). Immunohistochemistry with E1L3N clone is one of the most widely used and inexpensive laboratory-developed tests for PD-L1, but still need to be compared and validated with standard methods for clinical application.
Methods:
We investigated the performance of E1L3N clone for PD-L1 testing in 299 tumor tissues of NSCLC patients and its comparability with FDA-approved 22C3 clone.
Results:
The results show that the negative coincidence rate, weak positive coincidence rate, and positive coincidence rate were 97.4%, 92.2%, and 97.6% using the E1L3N assay relative to the 22C3 assay, respectively. An overall agreement of 96.3% was achieved between these two assays. We also found that the overall concordances were 97.8% and 93.9% for PD-L1 detection in large and small specimens, respectively, and no significant difference was obtained between these two assays (p = 0.076). In addition, the expression of PD-L1 was not detected in tumor tissues of benign lung disease using both the E1L3N and 22C3 assays.
Conclusion:
E1L3N can be used as a reliable alternative antibody clone to evaluate PD-L1 expression status for NSCLC patients.
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