China has the highest disease burden of esophageal cancer in the world. Early detection of esophageal cancer and precancerous lesions is key to improving patient survival rates and reducing incidence and mortality rates.
To explore the clinical application value of the esophageal novel cell collector in screening esophageal lesions, and to provide a basis for the governmental health departments to formulate more effective cancer prevention and control policies and public health programs.
From January 2024 to January 2025, 261 patients who completed esophageal novel cell collection, endoscopy, and pathological biopsy were conducted at nine hospitals in the Xinjiang region, including the First Affiliated Hospital of Shihezi University, Hongxing Hospital of the 13th Division, Beitun Hospital of the 10th Division, Kashi Campus of the General Hospital of the 3rd Division, Korla Hospital of the 2nd Division, Fourth Division Hospital, Seventh Division Hospital, Xinjiang Uygur Autonomous Region People's Hospital, and Tumushuk City of Third Division General Hospital. Using pathological biopsy as the gold standard, combined with morphological findings under gastroscopy, the subjects were divided into the early esophageal cancer and precancerous lesion group (n=34), the reflux esophagitis group (n=150), and the esophageal mucosa without abnormalities group (control group) (n=77). The diagnostic efficacy of cytological examination using a novel esophageal cell collector was evaluated in different populations.
Cytological examination results: 4 cases of cancer cells, 27 cases of high-grade intraepithelial lesions, 12 cases of low-grade intraepithelial lesions, 101 cases of atypical squamous cells, 111 cases of squamous cell hyperplasia/inflammatory cells, and 6 cases with no intraepithelial lesions or malignant cells. Endoscopic and pathological biopsy results: 4 cases of squamous cell carcinoma/adenocarcinoma cells, 19 cases of high-grade intraepithelial neoplasia, 11 cases of low-grade intraepithelial neoplasia, 20 cases of atypical squamous cells, 15 cases of inflammatory cells, 115 cases of regional edema/cell hyperplasia, and 77 cases of normal cells. The area under the receiver operating characteristic (ROC) curve of the novel esophageal cell collector for screening early esophageal cancer and precancerous lesions in the early esophageal cancer and precancerous lesion group and the control group was 0.933, with a sensitivity of 94.12%, a specificity of 67.53%, a positive predictive value of 56.14%, and a negative predictive value of 96.30%, and an overall accuracy of 75.68%. The area under the ROC curve of the novel esophageal cell collector for screening early esophageal cancer and precancerous lesions in the early esophageal cancer and precancerous lesion group and the reflux esophagitis group was 0.902, with a sensitivity of 94.12%, a specificity of 42.00%, a positive predictive value of 26.89%, a negative predictive value of 96.92%, and an overall accuracy of 51.63%. The new esophageal cell collector was highly safe (with a severe adverse event rate of 0) and highly acceptable (with an average visual analog scale score of 1.3). 93.9% (245/261) of participants indicated their willingness to undergo follow-up examinations for esophageal lesions using this method.
The novel esophageal cell collector demonstrates good diagnostic efficacy for early esophageal cancer and precancerous lesions, reducing the need for unnecessary endoscopic examinations. It features simple operation, high efficiency, safety, and high patient acceptability.
The accuracy of diffusing capacity of the lung for carbon monoxide (DLCO) instruments directly influences clinical decision-making in pulmonary diseases. However, long-term use of these instruments may lead to performance drift and measurement errors. At present, daily calibration using 3-L syringes and biological controls is commonly applied in clinical practice, but their sensitivity is insufficient to detect potential errors. Therefore, there is an urgent need to explore more precise and objective methods for quality evaluation of these instruments.
To evaluate the accuracy of DLCO instruments using a standard diffusion simulator that mimics human single-breath maneuvers, to identify and correct the sources of measurement errors, to observe the stability of calibration over time, and to assess the application value of this method in combination with biological control tests.
From March to July 2021, four DLCO instruments were tested in the pulmonary function laboratory of the National Clinical Research Center for Respiratory Diseases. A standard diffusion simulator (Hans Rudolph series 5560, USA) was employed with three carbon monoxide concentrations (0.08%, 0.10%, 0.13%) and three inhalation volumes (1.5 L, 3 L, 4.5 L) in different combinations to simulate single-breath DLCO tests. An absolute error of <2 mL·min-1·mmHg-1 between the measured and target DLCO values was defined as the acceptable range. The accuracy of four DLCO instruments (two brands, two models each) was evaluated as baseline, and the sources of measurement errors were analyzed. Each instrument was then corrected according to its error sources, and changes in accuracy before and after calibration as well as within three months were compared. Biological control testing was also performed to observe inter-instrument differences.
At baseline, 50% (2/4) of the instruments had a mean absolute DLCO error greater than 2 mL·min-1·mmHg-1. The error sources varied, including damaged components, incorrect calibration methods, and syringe leakage. After targeted corrections, all instruments achieved a mean absolute DLCO error within 2 mL·min-1·mmHg-1 (P<0.001), and this accuracy was maintained for three months. Post-calibration, the differences among instruments in biological control testing were significantly reduced, particularly in the range and coefficient of variation (CV) of DLCO measurements, which showed statistically significant improvements (P<0.05) .
DLCO instruments that have been in long-term clinical use show considerable variability in accuracy, with large measurement differences across instruments. Quality evaluation using a standard diffusion simulator is effective and feasible, enabling objective assessment of instrument accuracy and compensating for the limitations of routine calibration. Regular use of simulators is recommended for instrument quality evaluation and quality control.
