Abstract:

Objective To understand the status of pulmonary tuberculosis (TB) diagnosis after the implementation of the newly revised WS 288-2017 Diagnosis for pulmonary tuberculosis standard (hereinafter referred to as “new standard”), and the effect in improving the proportion of pathogenic positive in the patients registered for treatment and the quality of diagnosis in the patients with negative pathogen.Methods In accordance with the principle of voluntary assessment, eight provinces (Qinghai, Gansu, Xinjiang, Guizhou, Hubei, Guangxi, Shandong and Liaoning) were assessed, with one municipal specific hospital and three county-level institutions in each province. Assessment contents: the local tuberculosis registration data, tuberculosis imaging diagnosis and tuberculosis laboratory related tests before (2017) and after (2018) the implementation of the new standard were reviewed; the pathogenic negative pulmonary tuberculosis medical records, 50 cases in each site and each year were checked, as well as the laboratory register and retained sputum smear slides. A total of 3532 medical records of pathogenic negative pulmonary tuberculosis patients and 3260 sputum smears retained in the laboratory were checked. Chi-square test was used to compare the count data, with P＜0.05 as the difference statistically significant.Results After the implementation of the new standard, the detection ability of mycobacterium molecular biology increased from 18.2% (6/33) to 60.0% (15/25), the difference was statistically significant (χ²=9.035, P=0.003). The isolation and culture of mycobacterium increased from 93.9% (31/33) to 96.0% (24/25), with no significant difference (χ²=0.061, P=0.804). Through laboratory test quality assessment, we found that the quality of sputum specimen was not improved, 40.1% (384/957) of unqualified sputum samples in 2017 and 40.0% (922/2303) in 2018, and the difference was not statistically significant (χ²=0.000, P=0.993). The pathogenic positive rate of registered tuberculosis patients increased from 21.6% (4806/22258) to 24.7% (4026/16300), and the difference was statistically significant (χ²=51.200, P=0.000). The detection rate of tuberculosis antigen and antibody increased from 36.5% (871/2389) to 37.3% (426/1143), without statistically significant difference (χ²=0.186, P=0.667). The positive rate of tuberculosis antigen and antibody increased from 25.7% (224/871) to 41.3% (176/426), the difference was statistically significant (χ²=31.900, P=0.000). The detection rate of tuberculin test increased from 23.0% (549/2389) to 47.2% (539/1143), and the positive rate increased from 57.9% (318/549) to 73.3% (395/539), the difference was statistically significant (χ²=210.900, P=0.000; χ²=27.730, P=0.000). The detection rate of IFN-γ release test increased from 2.3% (54/2389) to 17.2% (197/1143), the difference was statistically significant (χ²=260.400, P=0.000). Patients met the clinical TB diagnosis standard increased from 23.8% (569/2389) to 48.1% (550/1143), the difference was statistically significant (χ²=209.800, P=0.000).Conclusion The implementation of the new standard has increased the pathogenic positive rate of registered pulmonary tuberculosis patients and improved the diagnostic quality of pathogenic negative pulmonary tuberculosis.

Key words: Tuberculosis,pulmonary, Diagnosis, Implementation, Outcome assessment (health care), Comparative study, Data interpretation,statistical