The feasibility of granzyme B levels using an amperometric immunosensor for lung cancer detection.

Background: Low-dose computed tomography (LDCT) has improved the early detection of lung cancer. However, LDCT scans present several disadvantages, including the abundance of false-positive results, which lead to a high socioeconomic cost, psychological burden, and repeated exposure to radiation. Therefore, the identification of complementary biomarkers is needed to select high-risk individuals for LDCT. Here, we showed that granzyme B testing with the novel immunosensor has diagnostic value for identifying patients with lung cancer. Methods: We enrolled 44 patients with lung cancer and 51 health controls at Pusan National University Yangsan Hospital in Korea between March 2018 and September 2019. The immunosensor analyzed serum granzyme B levels, and their association with lung cancer detection was evaluated with machine learning models. Results: Serum granzyme B levels were assessed in samples from patients with lung cancer and healthy individuals. Granzyme B testing showed 100% sensitivity, 80% specificity, and an area under the curve of 0.938 for lung cancer detection. After combining granzyme B testing with clinical predictors such as age, smoking status, or pack-years, results from the five-fold cross-validation with random forest model improved diagnostic accuracy of 92.1%, with a sensitivity, specificity, and area under the curve of 92.0%, 92.1%, and 0.977, respectively. Conclusions: This feasibility study suggested that granzyme B may be utilized to detect lung cancer.