Diagnostic accuracy of the updated FUJIFILM SILVAMP TB LAM II assay for pulmonary TB among HIV-negative outpatients at a primary-level clinic in rural China.

IF 4.6 2区医学 Q1 INFECTIOUS DISEASES

International Journal of Infectious Diseases Pub Date : 2026-10-06 DOI:10.1016/j.ijid.2026.109168

Gaoshun Xu, Yong Qiu, Mingcheng Guo, Rong Qu, Fajun Tian, Gengsheng Wang, Ya Wang, Meng Li, Peng Xu, Qian Gao

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引用次数: 0

Abstract

Objectives: Non-sputum-based diagnostic tests are a priority for tuberculosis (TB) control. However, studies regarding urine lipoarabinomannan (LAM) tests in HIV-negative population remain limited. This study aimed to evaluate the accuracy of FujiLAM II for pulmonary TB among HIV-negative outpatients in primary-level healthcare settings.

Methods: A prospective cohort study was conducted among outpatients with presumptive pulmonary TB and healthy controls in rural China. Urine samples from all participants were tested by FujiLAM II. Diagnostic accuracy was assessed against liquid culture, molecular test, microbiological reference standard (MRS) and composite reference standard (CRS).

Results: 408 presumptive pulmonary TB patients and 144 healthy controls were included, which were entirely HIV-negative. Among presumptive patients, 125 (30.6%) were MRS-positive and 149 (36.5%) were CRS-positive. All healthy controls were LAM-negative. Using liquid culture as the reference standard, FujiLAM II had a sensitivity of 35.8% (95% CI: 26.4-46.3) and a specificity of 94.2% (95% CI: 90.9-96.5). Against molecular assay, the sensitivity and specificity were 30.3% (95% CI: 22.3-39.5) and 94.5% (95% CI: 91.0-96.7). The sensitivities were 29.6% (95% CI: 21.9-38.5) and 29.5% (95% CI: 22.5-37.6) against MRS and CRS, respectively, with the corresponding specificities of 94.7% (95% CI: 91.2-96.9) and 96.9% (95% CI: 93.8-98.6). LAM-positive cases had a significantly shorter median liquid-culture time to positivity (9.5 vs 14.8 days, P = 0.002) and were more frequently smear-positive (35.3% vs 13.3%, P = 0.018) than LAM-negative cases, suggesting that bacillary burden may influence FujiLAM II results.

Conclusions: FujiLAM II could serve as a complementary tool with high specificity but limited sensitivity for pulmonary TB diagnosis among HIV-negative outpatients in primary healthcare settings.

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更新后的FUJIFILM SILVAMP TB LAM II检测在中国农村地区hiv阴性门诊患者中诊断肺结核的准确性

目的：非痰诊断试验是结核病控制的重点。然而，关于在hiv阴性人群中进行尿脂阿拉伯糖甘露聚糖（LAM）检测的研究仍然有限。本研究旨在评估FujiLAM II在初级卫生保健机构hiv阴性门诊患者中治疗肺结核的准确性。方法：对中国农村地区肺结核门诊患者和健康对照者进行前瞻性队列研究。所有参与者的尿液样本均由富士ilam II进行检测。采用液体培养、分子试验、微生物标准品（MRS）和复合标准品（CRS）评价诊断准确性。结果：纳入408例推定肺结核患者和144例健康对照，全部为hiv阴性。在推定患者中，125例（30.6%）为mrs阳性，149例（36.5%）为crs阳性。所有健康对照均为lam阴性。以液体培养为参比标准，FujiLAM II的灵敏度为35.8% (95% CI 26.4-46.3)，特异性为94.2% （95% CI 90.9-96.5）。与分子分析相比，敏感性和特异性分别为30.3% （95% CI 22.3-39.5）和94.5% （95% CI 91.0-96.7）。对MRS和CRS的敏感性分别为29.6% （95% CI 21.9 ~ 38.5）和29.5% (95% CI 22.5 ~ 37.6)，相应的特异性分别为94.7% （95% CI 91.2 ~ 96.9）和96.9% （95% CI 93.8 ~ 98.6）。lam阳性病例液培养至阳性的中位时间（9.5天vs 14.8天，P = 0.002）显著短于lam阴性病例，涂片阳性的发生率（35.3% vs 13.3%, P = 0.018）显著高于lam阴性病例，提示细菌负荷可能影响FujiLAM II结果。结论：FujiLAM II可作为初级卫生保健机构中hiv阴性门诊患者肺结核诊断的高特异性但灵敏度有限的补充工具。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Infectious Diseases 医学-传染病学

CiteScore

18.90

自引率

2.40%

发文量

1020

审稿时长

30 days

期刊介绍： International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.