关键词: 结核, 实验室,医院, 诊断技术和方法, 评价研究

Abstract:

Objective: To evaluate the diagnostic capabilities and quality control measures in tuberculosis-designated hospitals across China. Methods: This study utilized data from the 2023 ‘Research on the Prevention and Control System and Operation Mechanism of National Tuberculosis Medical Institutions’ conducted by the Clinical Center for Tuberculosis Prevention and Control of China CDC. These data were compared with survey data from 2015 to analyze the status and trends of tuberculosis laboratory testing technologies. Both surveys encompassed 46 units, including general hospitals, infectious disease hospitals, tuberculosis prevention and control institutions, public health centers, and specialized tuberculosis hospitals. Results: Among the 46 designated medical institutions for tuberculosis, 19 (41.3%) were provincial institutions and 27 (58.7%) were municipal institutions. In 2022, the average number of outpatient visits per institution was 16424, including 185 visits for multidrug/rifampicin-resistant tuberculosis. On average, 1460 tuberculosis patients were admitted per institution, including 131 patients with multidrug/rifampicin-resistant tuberculosis. In terms of laboratory testing, these institutions primarily utilized three routine techniques in 2022: smear microscopy, culture, and drug susceptibility testing. From the perspective of different types of institutions, the implementation rates of PCR detection (70.8%, 17/24), gene chip detection (37.5%, 9/24), and molecular strain identification (58.3%, 14/24) in third-grade class-A medical institutions were significantly higher than those in other grade medical institutions (27.3% (6/22), 4.5% (1/22), and 22.7% (5/22), respectively; χ²=8.712, 5.518, and 6.002, P=0.003, 0.019, and 0.014). Additionally, the overall workload of traditional tuberculosis laboratory detection techniques (sputum smear, sputum culture, and traditional drug susceptibility testing; 19825 (11253, 38363), 13266 (4164, 24213), and 1264 (534, 2523) cases) was significantly higher than that in other medical institutions (8072 (2132, 17239), 2292 (1076, 10075), and 323 (101, 1572) cases, respectively; Z=-2.452, -2.702, and -2.225, P=0.014, 0.007 and 0.026). From a regional distribution perspective, the high-resolution melting curve detection rate in the eastern region (35.3%, 6/17) was slightly lower than that in the central region (76.5%, 13/17), with the difference being statistically significant (χ²=6.494, P=0.039). Historically, in 2022, simple and rapid diagnostic techniques such as GeneXpert MTB/RIF detection (93.5%, 43/46) and gene chip detection (21.7%, 10/46) were more widely used compared to 2014 (41.3% (19/46) and 8.7% (4/46), respectively). Furthermore, the diagnostic workload of GeneXpert MTB/RIF increased from 38 (11, 150) cases diagnosed in 2014 to 2485 (856, 8349) cases in 2022 (Z=-3.724, P<0.001), and antibody detection increased from 500 (200, 1010) cases in 2014 to 3401 (1066, 7275) cases in 2022 (Z=-4.235, P<0.001), indicating an upward trend. In terms of laboratory quality control, the oversight of cultivation techniques remained a critical focus area. In 2022, only 76.1% (35/46) of medical institutions participated in inter-laboratory quality control, with the majority being monitored by third-party institutions (74.3%, 26/35). Conclusion: Since 2014, the laboratory detection capabilities of tuberculosis-designated medical institutions in China have improved to varying degrees, particularly in molecular biology detection. Moving forward, while continuing to enhance tuberculosis laboratory detection capabilities, ensuring the quality of laboratory work will be a critical area of focus.

Key words: Tuberculosis, Laboratories, hospital, Diagnostic techniques and procedures, Evaluation studies