Applicability of TB-LAMP test for diagnosis of pulmonary TB among HIV-positive individuals.

B Muriithi, M M Bundi, T Moriyasu, A Ahmed, M Mwamzuka, M Karama, S Kaneko
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

TB- lamp检测在hiv阳性人群中诊断肺结核的适用性
背景:环介导的TB等温扩增(TB- lamp)检测比Xpert®MTB/RIF检测更具成本效益和可及性。本研究旨在评估TB-LAMP检测在HIV感染者和非HIV感染者中的诊断性能。方法:年龄≥15岁出现结核症状的患者纳入研究。TB- lamp检测与常规结核病诊断方法(包括Xpert检测和涂片镜检)一起进行,以评估检测结果的差异和相关因素。结果:共有903例患者入组研究。与Xpert试验相比,涂片镜检和TB-LAMP的阳性一致性百分比分别为54.3% (95% CI 46.6-61.8)和76.6% (95% CI 699 -82.6)。在hiv阳性个体中,涂片镜检阳性百分比为42.5% (95% CI 32.9-52.4), TB-LAMP阳性百分比为68.9% (95% CI 59.1-77.5)。TB-LAMP和Xpert结果之间的差异与年龄(调整后OR为3.29,95% CI为0.32-33.83)、食欲不振(调整后OR为0.30,95% CI为0.13-0.70)和hiv阳性状态(调整后OR为3.29,95% CI为1.12-9.63)等因素相关。结论:与涂片镜检相比,TB- lamp在检测hiv阳性患者结核病方面与Xpert法具有更好的一致性,提示TB- lamp可有效替代涂片镜检。
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