Open AccessClinical evaluation of a laboratory‐developed test using clone E1L3N for the detection of PD‐L1 expression status in non‐small cell lung cancer
Author(s) -
Xu Hanyan,
Dong Xidan,
Zhao Hanxin,
Hou Tongtong,
Chen Chengshui,
Chen Guorong,
Ye Junru,
Li Yuping
Publication year - 2021
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.23696
Subject(s) - clone (java method) , lung cancer , immunohistochemistry , medicine , oncology , antibody , cancer , companion diagnostic , cancer research , immunology , biology , dna , genetics
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.