Ji Zhongkang, Bi Sheng, Lu Bin, Zheng Lin, Jin Xiuyuan, Huang Shujuan, Jiang Liangxiu, Wang Yuping, Ding Cheng, Xu Kaijin
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, People's Republic of China.
Department of Infectious Diseases, Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, People's Republic of China.
Infect Drug Resist. 2024 Oct 17;17:4467-4475. doi: 10.2147/IDR.S484123. eCollection 2024.
To assess the diagnostic performance of the blood-based Cepheid 3-gene Host Response test (MTB-HR), urine-based Lipoarabinomannan (LAM), and a combination of MTB-HR and LAM (MTB-HR & LAM) for detecting active tuberculosis (ATB).
All participants were recruited from the First Affiliated Hospital, Zhejiang University School of Medicine, between June 8, 2023 and September 13, 2023. Subsequently, the participants were classified into the ATB group or non-active tuberculosis (non-ATB) group based on microbiological evidence. MTB-HR and LAM tests were performed using fingerstick blood and urine samples from each participant, respectively. The diagnostic performance of the tests was evaluated based on the sensitivity, specificity, Youden index, and Kappa value. Pairwise comparisons of the areas under the receiver operating characteristic curves (AUROCs) between different tests were conducted using nonparametric methods.
A total of 297 participants were included. The MTB-HR test demonstrated diagnostic efficacy with a sensitivity of 77.37% (95% CI: 70.37-84.38) and a specificity of 85.63% (95% CI: 80.19-91.06). The LAM test demonstrated a high specificity of 97.50% (95% CI: 95.08-99.92), albeit with a lower sensitivity of 54.74% (95% CI: 46.41-63.082). The sensitivity and specificity of the MTB-HR & LAM were 83.21% (95% CI: 76.95-89.47) and 83.13% (95% CI: 77.32-88.93), respectively. Only MTB-HR & LAM exhibited higher values of area under the receiver operating characteristic curve than the LAM test (MTB-HR & LAM vs LAM: 0.83 vs 0.76, P=0.0031).
In this study, although both non-sputum-based triage MTB-HR and LAM do not meet the WHO diagnostic target currently, they show possible values for triage and diagnosis in ATB. Compared to single MTB-HR or LAM test, the combined MTB-HR & LAM does not demonstrate advantages.
评估基于血液的赛沛3基因宿主反应检测（MTB-HR）、基于尿液的脂阿拉伯甘露聚糖（LAM）以及MTB-HR与LAM联合检测（MTB-HR & LAM）对检测活动性肺结核（ATB）的诊断性能。
所有参与者均于2023年6月8日至2023年9月13日期间从浙江大学医学院附属第一医院招募。随后，根据微生物学证据将参与者分为ATB组或非活动性肺结核（非ATB）组。分别使用每位参与者的指尖血和尿液样本进行MTB-HR和LAM检测。基于敏感性、特异性、约登指数和kappa值评估检测的诊断性能。使用非参数方法对不同检测之间的受试者工作特征曲线下面积（AUROC）进行两两比较。
共纳入297名参与者。MTB-HR检测显示出诊断效能，敏感性为77.37%（95%CI：70.37 - 84.38），特异性为85.63%（95%CI：80.19 - 91.06）。LAM检测显示出97.50%（95%CI：95.08 - 99.92）的高特异性，尽管敏感性较低，为54.74%（95%CI：46.41 - 63.082）。MTB-HR & LAM的敏感性和特异性分别为83.21%（95%CI：76.95 - 89.47）和83.13%（95%CI：77.32 - 88.93）。只有MTB-HR & LAM的受试者工作特征曲线下面积值高于LAM检测（MTB-HR & LAM与LAM比较：0.83对0.76，P = 0.0031）。
在本研究中，尽管基于非痰液的分流检测MTB-HR和LAM目前均未达到世界卫生组织的诊断目标，但它们在ATB的分流和诊断中显示出可能的价值。与单独的MTB-HR或LAM检测相比，联合检测MTB-HR & LAM未显示出优势。
