Abstract:

Objective: To analyze the diagnostic quality of pathogenic negative pulmonary tuberculosis in county level tuberculosis designated hospitals in Gansu Province, so as to further improve the diagnostic quality of pathogen negative pulmonary tuberculosis. Methods: The cross-sectional method was used to collect the data of active tuberculosis patients registered in Tuberculosis Information Management System in Gansu Province in 2021. The stratified cluster sampling method was used to select the clusters. Three cities were selected from the central, western and eastern parts of Gansu Province. Each city and prefecture selected three county level designated hospitals with the top three registered patients as the survey sites. The investigators collected the complete data of pathogenic negative pulmonary tuberculosis patients (except for tracheobronchial tuberculosis and tuberculous pleurisy) registered at each survey site through the “Field questionnaire of pathogenic negative pulmonary tuberculosis patients in Gansu Province”, and evaluated the diagnostic quality of pathogenic negative pulmonary tuberculosis from five aspects, including diagnostic process, diagnostic evidence, laboratory examination, imaging examination and diagnostic anti-infection treatment. Results: A total of 1187 pathogenic negative pulmonary tuberculosis patients who met the enrollment criteria from 26 designated hospitals were collected. Nine hundred and forty-one cases (79.28%) received standardized diagnostic procedures, and 699 cases (58.89%) diagnostic evidence met the requirements, 1176 cases (99.07%) received bacteriological examination, of which 1169 cases (98.48%), 368 cases (31.00%), 900 cases (75.82%) and 103 cases (8.68%) were examined for sputum smear, mycobacterium culture, molecular biology, and tuberculosis pathology, respectively, 1084 (91.32%) had qualified sputum specimens. Nine hundred and fifty-eight cases (80.71%) received at least one tuberculosis immunological examination. Among them, 724 cases (60.99%), 574 cases (48.36%) and 382 cases (32.18%) were provided tuberculin test, anti-tuberculosis antibody test and interferon-γ release test, respectively. The positive cases were 572 cases (79.01%), 187 cases (32.58%) and 329 cases (86.13%), respectively. Bronchoscopy and pleural effusion examination were performed in 198 cases (16.68%) and 29 cases (2.44%), the positive cases were all 0 cases, respectively. In the 1187 cases (100.00%) underwent imaging examinations, the chest X-ray examination rate (73.21% (869/1187)) and the qualification rate (85.04% (739/869)) were significantly lower than CT examination (99.16% (1177/1187)) and 92.78% (1092/1177), respectively), and the differences were statistically significant (χ²=335.585, P=0.000; χ²=31.829, P=0.000). The diagnostic team discussed 1166 patients (98.23%) and recommended diagnostic anti tuberculosis treatment for 626 patients, while 563 patients (89.94%) were actually treated. Conclusion: The sputum smear and the molecular biological examination of laboratory tests on pathogenic negative pulmonary tuberculosis were mainly used in the designated county (district) level tuberculosis hospitals in Gansu Province. The examination rate and pass rate of CT were relatively high, but molecular biology examination rate, diagnostic process rate and diagnostic rate still have larger space. It is suggested to strengthen the testing procedures and training of technical personnel at county level designated hospitals, and strictly implement the tuberculosis-related examination procedures, and further improve the quality of pathogenic negative pulmonary tuberculosis diagnosis.

Key words: Tuberculosis, pulmonary, Clinical laboratory techniques, Etiological diagnosis, Factor analysis,statistical, Outcome assessment (health care)