The Sensitivity and Specificity of Loop-Mediated Isothermal Amplification (LAMP) Assay for Tuberculosis Diagnosis in Adults with Chronic Cough in Malawi.
The Sensitivity and Specificity of Loop-Mediated Isothermal Amplification (LAMP) Assay for Tuberculosis Diagnosis in Adults with Chronic Cough in Malawi.
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DOI：
10.1371/journal.pone.0155101
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Corbett EL
中科院分区：
文献类型：
--
作者：
Nliwasa M;MacPherson P;Chisala P;Kamdolozi M;Khundi M;Kaswaswa K;Mwapasa M;Msefula C;Sohn H;Flach C;Corbett EL
目前的结核病诊断缺乏敏感性，而且价格昂贵。在艾滋病毒感染率高、资源匮乏的环境中，现场护理需要高度准确、快速和便宜的诊断测试。与 Xpert® MTB/RIF、荧光涂片显微镜相比，研究环介导等温扩增 (LAMP) 检测用于慢性咳嗽成人结核病诊断的敏感性、特异性和成本。 2013 年 10 月至 2014 年 3 月期间，初级保健诊所连续对成年人进行了咳嗽筛查，提供了 HIV 检测，并使用 LAMP、Xpert® MTB/RIF 和荧光涂片显微镜进行了结核病评估。估计了敏感性和特异性（以培养物作为参考标准）和成本。在招募的 273 名成年人中，44.3% (121/273) 为 HIV 阳性，19.4% (53/273) 经细菌学证实患有结核病。与培养相比，LAMP 的敏感性为 65.0%（95% CI：48.3% 至 79.4%），特异性为 100%（95% CI：98.0% 至 100%）。 Xpert® MTB/RIF 的灵敏度（77.5%，95% CI：61.5% 至 89.2%）与 LAMP 相似，p = 0.132。常规双读浓缩荧光涂片显微镜的灵敏度（87.5％，95％CI：73.2％至95.8％）高于LAMP，p = 0.020。所有三个测试都具有很高的特异性。每次 LAMP 测试的成本最低的是批量大小为 14 个样品的情况（9.98 美元）；这低于 Xpert® MTB/RIF（13.38 美元），但高于荧光涂片显微镜检查（0.65 美元）。 LAMP 的灵敏度与 Xpert® MTB/RIF 相似，但低于荧光涂片显微镜；所有三个测试都具有很高的特异性。这些发现支持马拉维的政策，该政策建议将荧光涂片显微镜和 Xpert® MTB/RIF 结合起来，优先用于已发现涂片阴性或正在考虑重新治疗结核病的 HIV 感染者。
Current tuberculosis diagnostics lack sensitivity, and are expensive. Highly accurate, rapid and cheaper diagnostic tests are required for point of care use in low resource settings with high HIV prevalence. To investigate the sensitivity and specificity, and cost of loop-mediated isothermal amplification (LAMP) assay for tuberculosis diagnosis in adults with chronic cough compared to Xpert® MTB/RIF, fluorescence smear microscopy. Between October 2013 and March 2014, consecutive adults at a primary care clinic were screened for cough, offered HIV testing and assessed for tuberculosis using LAMP, Xpert® MTB/RIF and fluorescence smear microscopy. Sensitivity and specificity (with culture as reference standard), and costs were estimated. Of 273 adults recruited, 44.3% (121/273) were HIV-positive and 19.4% (53/273) had bacteriogically confirmed tuberculosis. The sensitivity of LAMP compared to culture was 65.0% (95% CI: 48.3% to 79.4%) with 100% (95% CI: 98.0% to 100%) specificity. The sensitivity of Xpert® MTB/RIF (77.5%, 95% CI: 61.5% to 89.2%) was similar to that of LAMP, p = 0.132. The sensitivity of concentrated fluorescence smear microscopy with routine double reading (87.5%, 95% CI: 73.2% to 95.8%) was higher than that of LAMP, p = 0.020. All three tests had high specificity. The lowest cost per test of LAMP was at batch size of 14 samples (US$ 9.98); this was lower than Xpert® MTB/RIF (US$ 13.38) but higher than fluorescence smear microscopy (US$ 0.65). The sensitivity of LAMP was similar to Xpert® MTB/RIF but lower than fluorescence smear microscopy; all three tests had high specificity. These findings support the Malawi policy that recommends a combination of fluorescence smear microscopy and Xpert® MTB/RIF prioritised for people living with HIV, already found to be smear-negative, or being considered for retreatment of tuberculosis.