Background To improve tuberculosis case-finding, rapid, non-sputum triage tests need to be developed according to the World Health Organization target product profile (TPP) (>90% sensitivity, >70% specificity). We prospectively evaluated and compared artificial intelligence–based, computer-aided detection software, CAD4TBv7, and C-reactive protein assay (CRP) as triage tests at health facilities in Lesotho and South Africa. Methods Adults (≥18 years) presenting with ≥1 of the 4 cardinal tuberculosis symptoms were consecutively recruited between February 2021 and April 2022. After informed consent, each participant underwent a digital chest X-ray for CAD4TBv7 and a CRP test. Participants provided 1 sputum sample for Xpert MTB/RIF Ultra and Xpert MTB/RIF and 1 for liquid culture. Additionally, an expert radiologist read the chest X-rays via teleradiology. For primary analysis, a composite microbiological reference standard (ie, positive culture or Xpert Ultra) was used. Results We enrolled 1392 participants, 48% were people with HIV and 24% had previously tuberculosis. The receiver operating characteristic curve for CAD4TBv7 and CRP showed an area under the curve of .87 (95% CI: .84–.91) and .80 (95% CI: .76–.84), respectively. At thresholds corresponding to 90% sensitivity, specificity was 68.2% (95% CI: 65.4–71.0%) and 38.2% (95% CI: 35.3–41.1%) for CAD4TBv7 and CRP, respectively. CAD4TBv7 detected tuberculosis as well as an expert radiologist. CAD4TBv7 almost met the TPP criteria for tuberculosis triage. Conclusions CAD4TBv7 is accurate as a triage test for patients with tuberculosis symptoms from areas with a high tuberculosis and HIV burden. The role of CRP in tuberculosis triage requires further research. Clinical Trials Registration Clinicaltrials.gov identifier: NCT04666311.

中文翻译：

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在莱索托和南非的卫生机构进行 C 反应蛋白评估和胸部 X 光片的计算机辅助分析作为结核病分诊检测


背景 为了提高结核病病例的发现，需要根据世界卫生组织目标产品概况 （TPP） 开发快速、非痰液分流检测（>90% 敏感性，>70% 特异性）。我们前瞻性地评估和比较了基于人工智能的计算机辅助检测软件、CAD4TBv7 和 C 反应蛋白检测 （CRP） 作为莱索托和南非卫生机构的分诊检测。方法 在 2021 年 2 月至 2022 年 4 月期间连续招募了 4 种主要结核病症状中 ≥1 种的成人 （≥18 岁）。在知情同意后，每个参与者都接受了 CAD4TBv7 的数字胸部 X 光检查和 CRP 测试。参与者提供了 1 份用于 Xpert MTB/RIF Ultra 和 Xpert MTB/RIF 的痰液样本，以及 1 份用于液体培养的痰液样本。此外，放射科医生专家通过远程放射学读取胸部 X 光片。对于初步分析，使用复合微生物参考标准品（即阳性培养或 Xpert Ultra）。结果 我们招募了 1392 名参与者，其中 48% 是 HIV 感染者，24% 以前患有肺结核。CAD4TBv7 和 CRP 的受试者工作特征曲线分别显示 .87 （95% CI： .84–.91） 和 .80 （95% CI： .76–.84） 的曲线下面积。在对应于 90% 敏感性的阈值下，CAD4TBv7 和 CRP 的特异性分别为 68.2% （95% CI： 65.4–71.0%） 和 38.2% （95% CI： 35.3–41.1%）。CAD4TBv7 以及放射科医生专家检测到了结核病。CAD4TBv7 几乎满足结核病分诊的 TPP 标准。结论 CAD4TBv7 作为来自结核病和 HIV 负担高地区的有结核病症状的患者的分诊检测是准确的。CRP 在结核病分诊中的作用需要进一步研究。临床试验注册 临床试验.gov 标识符：NCT04666311。