Muriithi B, Bundi M M, Moriyasu T, Ahmed A, Mwamzuka M, Karama M, Kaneko S
Nairobi Research Station, Nagasaki University Institute of Tropical Medicine (NUITM)-Kenya Medical Research Institute (KEMRI) Project, Nairobi, Kenya.
Kenya Medical Research Institute, KEMRI Graduate School, Nairobi, Kenya.
IJTLD Open. 2025 Jan 1;2(1):26-32. doi: 10.5588/ijtldopen.24.0410. eCollection 2025 Jan.
The loop-mediated isothermal amplification for TB (TB-LAMP) assay is more cost-effective and accessible than the Xpert MTB/RIF assay. This study aimed to evaluate the diagnostic performance of the TB-LAMP assay in individuals with and without HIV infection.
Patients aged ≥15 years presenting with symptoms of TB were included in the study. The TB-LAMP assay was performed alongside routine TB diagnostic methods, including the Xpert assay and smear microscopy, to evaluate discrepancies in test results and associated factors.
A total of 903 patients were enrolled in the study. The positive percentage agreement for smear microscopy and TB-LAMP compared with the Xpert assay was respectively 54.3% (95% CI 46.6-61.8) and 76.6% (95% CI 69.9-82.6). Among HIV-positive individuals, the positive percentage agreement was 42.5% (95% CI 32.9-52.4) for smear microscopy and 68.9% (95% CI 59.1-77.5) for TB-LAMP. Factors such as age >60 years (adjusted OR 3.29, 95% CI 0.32-33.83), loss of appetite (aOR 0.30, 95% CI 0.13-0.70), and HIV-positive status (aOR 3.29, 95% CI 1.12-9.63) were associated with discrepancies between TB-LAMP and Xpert results.
TB-LAMP demonstrated better agreement with the Xpert assay compared with smear microscopy in detecting TB among HIV-positive patients, suggesting that TB-LAMP could effectively replace smear microscopy.
用于结核病检测的环介导等温扩增技术(TB-LAMP)检测比Xpert MTB/RIF检测更具成本效益且更容易获得。本研究旨在评估TB-LAMP检测在有和没有HIV感染个体中的诊断性能。
年龄≥15岁且有结核病症状的患者纳入本研究。TB-LAMP检测与常规结核病诊断方法(包括Xpert检测和涂片显微镜检查)同时进行,以评估检测结果的差异及相关因素。
本研究共纳入903例患者。与Xpert检测相比,涂片显微镜检查和TB-LAMP检测的阳性百分比一致性分别为54.3%(95%CI 46.6-61.8)和76.6%(95%CI 69.9-82.6)。在HIV阳性个体中,涂片显微镜检查的阳性百分比一致性为42.5%(95%CI 32.9-52.4),TB-LAMP检测为68.9%(95%CI 59.1-77.5)。年龄>60岁(调整后OR 3.29,95%CI 0.32-33.83)、食欲不振(调整后OR 0.30,95%CI 0.13-0.70)和HIV阳性状态(调整后OR 3.29,95%CI 1.12-9.63)等因素与TB-LAMP和Xpert检测结果的差异相关。
在HIV阳性患者中检测结核病时,与涂片显微镜检查相比,TB-LAMP与Xpert检测的一致性更好,表明TB-LAMP可有效替代涂片显微镜检查。