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Background Circulating genetically abnormal cells (CACs) with specific chromosome variations have been confirmed to be present in non‐small cell lung cancer (NSCLC). However, the diagnostic performance of CAC detection remains unclear. This study aimed to evaluate the potential clinical application of the CAC test for the early diagnosis of NSCLC. Methods In this prospective study, a total of 339 participants (261 lung cancer patients and 78 healthy volunteers) were enrolled. An antigen‐independent fluorescence in situ hybridization was used to enumerate the number of CACs in peripheral blood. Results Patients with early‐stage NSCLC were found to have a significantly higher number of CACs than those of healthy participants (1.34 vs . 0.19; P < 0.001). The CAC test displayed an area under the receiver operating characteristic (ROC) curve of 0.76139 for discriminating stage I NSCLC from healthy participants with 67.2% sensitivity and 80.8% specificity, respectively. Compared with serum tumor markers, the sensitivity of CAC assays for distinguishing early‐stage NSCLC was higher (67.2% vs. 48.7%, P < 0.001), especially in NSCLC patients with small nodules (65.4% vs. 36.5%, P = 0.003) and ground‐glass nodules (pure GGNs: 66.7% vs. 40.9%, P = 0.003; mixed GGNs: 73.0% vs. 43.2%, P < 0.001). Conclusions CAC detection in early stage NSCLC was feasible. Our study showed that CACs could be used as a promising noninvasive biomarker for the early diagnosis of NSCLC. Key points What this study adds: This study aimed to evaluate the potential clinical application of the CAC test for the early diagnosis of NSCLC. Significant findings of the study: CAC detection in early stage NSCLC was feasible. Our study showed that CACs could be used as a promising noninvasive biomarker for the early diagnosis of NSCLC.

A new anticalin against estradiol (E 2 ), a kind of endocrine disruptor, was obtained in the present study to detect E 2 levels. A member of the lipocalin family from Pieris brassicae called bilin-binding protein (BBP) was employed for the preparation of a random library to specifically complex E 2 . Sixteen amino acid residues at the center of the binding site, which were formed by four loops on top of an eightstranded b-barrel, were subjected to targeted random mutagenesis. Estradiol-binding BBP variants socalled 'anticalins', which exhibit binding activity for compounds, such as E 2 , were selected from the resulting library by combining both ribosome display and screening techniques. Four variants of complex E 2 with high affinity were identified. These variants exhibited dissociation constants (KDs) as low as 54.265 nM. ELISA showed that ribosome displayed anticalin (E 2 -A) specifically bound E 2 . The 50% inhibition concentration (IC 50 ) for E 2 was 50 ng mL À1 and the limit of detection (LOD:IC 10 ) was 0.071 ng mL À1 . The experimental results suggest that E 2 -A can be used as a potential anticalin to detect E 2 in animals.

BackgroundLung cancer screening using low-dose computed tomography (LDCT) often leads to unnecessary biopsy because of the low specificity among patients with pulmonary nodules ≤10 mm. Circulating genetically abnormal cells (CACs) can be used to discriminate lung cancer from benign lung disease. To examine the diagnostic value of CACs in detecting lung cancer for patients with malignant pulmonary nodules ≤10 mm.MethodsIn this prospective study, patients with pulmonary nodules ≤10 mm who were detected at four hospitals in China from January 2019 to January 2020 were included. CACs were detected using fluorescence in-situ hybridization. All patients were confirmed as lung cancer or benign disease by further histopathological examination. Multivariable logistic regression models were established to detect the presence of lung cancer using CACs and other associated characteristics. Receiver operating characteristic analysis was used to evaluate the performance of CACs for lung cancer diagnosis.ResultsOverall, 125 patients were included and analyzed. When the cutoff value of CACs was &gt;2, the sensitivity and specificity for lung cancer were 70.5 and 86.4%. Male (OR = 0.330, P = 0.005), maximum solid nodule (OR = 2.362, P = 0.089), maximum nodule located in upper lobe (OR = 3.867, P = 0.001), and CACs &gt;2 (OR = 18.525, P &lt; 0.001) met the P &lt; 0.10 criterion for inclusion in the multivariable models. The multivariable logistic regression model that included the dichotomized CACs (&gt;2 vs. ≤2) and other clinical factors (AUC = 0.907, 95% CI = 0.842–0.951) was superior to the models that only considered dichotomized CACs or other clinical factors and similar to the model with numerical CACs and other clinical factors (AUC = 0.913, 95% CI = 0.850–0.956).ConclusionCACs presented a significant diagnostic value in detecting lung cancer for patients with pulmonary nodules ≤10 mm.