Objective: To analyze the diagnostic efficacy of urinary lipoarabinomannan (LAM) antigen detection method in tuberculosis patients, and to provide an experimental basis for the clinical application of urinary LAM kit in China. Methods: From March to May 2023, 228 patients with lung diseases [134 male, 94 female, age 20-82 (44.8±16.7) years] were prospectively collected in Beijing Chest Hospital, Capital Medical University, including 143 pulmonary tuberculosis patients and 85 non-tuberculosis patients. Urine and sputum samples from patients were collected for traditional etiological detection and urinary LAM antigen detection. The screening results of each positive detection combination were analyzed, and the difference analysis and regression analysis were performed. Results: The detection sensitivity and specificity of the urinary LAM kit were 46.2% (95%CI: 37.9%-54.7%) and 96.5% (95%CI: 89.3%-99.1%), respectively, with an overall coincidence rate of 64.9%. The detection rate of LAM antigen detection and GeneXpert MTB/RIF (Xpert) combined (60.8%, 87/143) was significantly higher than that of Xpert alone (49.7%, 71/143), and the difference was statistically significant (P<0.05). The results of risk factor analysis showed that the risk of negative urinary LAM antigen test results increased significantly as the bacterial load decreased. Conclusions: Urine LAM antigen detection method has a high specificity and can be combined with traditional methods to effectively improve the detection rate. Urinary LAM antigen detection method still has limitations, such as the influence of bacterial load and the inability to distinguish nontuberculosis mycobacteria samples, which needs further experimental verification.
目的： 分析尿液的脂阿拉伯甘露聚糖（LAM）抗原检测方法对肺结核患者的诊断价值，为尿液LAM抗原试剂盒在中国地区的推广提供依据。 方法： 2023年3—5月，前瞻性收集首都医科大学附属北京胸科医院诊治肺部疾病患者228例［男134例，女94例，年龄20~82（44.8±16.7）岁］，其中肺结核患者143例，非结核病患者85例。收集所有患者的痰标本和尿液，进行传统病原学检测和尿液LAM抗原检测，分析各检测阳性组合的筛查结果，并通过卡方检验等统计学方法对结果进行进一步分析。 结果： 尿液LAM试剂盒的检测敏感度为46.2%（95%CI：37.9%~54.7%），检测特异度为96.5%（95%CI：89.3%~99.1%），总体符合率为64.9%。联合应用尿液LAM抗原检测和结核分枝杆菌/利福平耐药实时荧光定量核酸扩增检测（Xpert）两种方法检测阳性样本的检出率（60.8%，87/143）高于单独应用Xpert检测阳性样本的检出率（49.7%，71/143），差异有统计学意义（P<0.05）。风险因素分析结果表明，尿液LAM抗原检测结果阴性的风险随着细菌载量的降低而增加。 结论： 尿液LAM抗原检测方法特异度高，与传统病原学联用可有效提高检出率。尿液LAM抗原检测法仍具有受细菌载量影响和区分非结核分枝杆菌样本能力不强等局限性，需进一步试验验证。.