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TB-LAMP 诊断检测在参考实验室中的表现：一项多中心研究的结果。

Performance of the TB-LAMP diagnostic assay in reference laboratories: Results from a multicentre study.

机构信息

Pham Ngoc Thach Tuberculosis and Lung Disease Hospital, Ho Chi Minh, Vietnam.

Lung Infection and Immunity Unit, Department of Medicine and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.

出版信息

Int J Infect Dis. 2018 Mar;68:44-49. doi: 10.1016/j.ijid.2018.01.005. Epub 2018 Feb 2.

DOI:10.1016/j.ijid.2018.01.005
PMID:29410366
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5890091/
Abstract

OBJECTIVE

To evaluate the diagnostic performance of TB-LAMP, a manual molecular tuberculosis (TB) detection method, and provide comparison to the Xpert MTB/RIF assay.

METHODS

In a large multicentre study, two sputum samples were collected from participants with TB symptoms in reference laboratories in Peru, South Africa, Brazil, and Vietnam. Each sample was tested with TB-LAMP. The reference standard consisted of four direct smears, four cultures, and clinical and radiological findings. Individuals negative on conventional tests were followed up after 8 weeks. The Xpert MTB/RIF assay was performed on fresh or frozen samples as a molecular test comparison.

RESULTS

A total of 1036 adults with suspected TB were enrolled. Among 375 culture-confirmed TB cases with 750 sputum samples, TB-LAMP detected 75.6% (95% confidence interval (CI) 71.8-79.4%), including 97.9% (95% CI 96.4-99.4%) of smear-positive TB samples and 46.6% (95% CI 40.6-52.7%) of smear-negative TB samples. Specificity in 477 culture-negative participants not treated for TB (954 sputum samples) was 98.7% (95% CI 97.9-99.6%). TB-LAMP test results were indeterminate in 0.3% of cases.

CONCLUSIONS

TB-LAMP detects nearly all smear-positive and half of smear-negative TB cases and has a high specificity when performed in reference laboratories. Performance was similar to the Xpert MTB/RIF assay.

摘要

目的

评估 TB-LAMP（一种手动分子结核检测方法）的诊断性能，并与 Xpert MTB/RIF 检测进行比较。

方法

在一项大型多中心研究中，从秘鲁、南非、巴西和越南的参考实验室具有结核病症状的参与者中收集了两份痰液样本。每份样本均进行 TB-LAMP 检测。参考标准包括四个直接涂片、四个培养物以及临床和影像学发现。对常规检测阴性的个体进行 8 周随访。Xpert MTB/RIF 检测作为分子检测比较，在新鲜或冷冻样本上进行。

结果

共纳入 1036 例疑似结核病的成年人。在 375 例培养确诊的结核病病例中，有 750 份痰液样本，TB-LAMP 检测到 75.6%（95%置信区间 71.8-79.4%），包括 97.9%（95%置信区间 96.4-99.4%）的涂片阳性结核病样本和 46.6%（95%置信区间 40.6-52.7%）的涂片阴性结核病样本。在未接受结核病治疗的 477 例培养阴性参与者（954 份痰液样本）中，特异性为 98.7%（95%置信区间 97.9-99.6%）。TB-LAMP 检测结果不确定的比例为 0.3%。

结论

TB-LAMP 几乎可以检测到所有涂片阳性和一半的涂片阴性结核病病例，在参考实验室中具有很高的特异性。其性能与 Xpert MTB/RIF 检测相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/817e/7110858/8699d0bc093c/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/817e/7110858/bedd7193956a/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/817e/7110858/8699d0bc093c/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/817e/7110858/bedd7193956a/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/817e/7110858/8699d0bc093c/gr2_lrg.jpg

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