EasyNAT MTC assay: A simple, rapid, and low-cost cross-priming amplification method for the detection of mycobacterium tuberculosis suitable for point-of-care testing.
EasyNAT MTC assay: A simple, rapid, and low-cost cross-priming amplification method for the detection of mycobacterium tuberculosis suitable for point-of-care testing.
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DOI：
10.1080/22221751.2021.1959271
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发表时间：
2021-12
影响因子：
13.2
通讯作者：
Huang H
中科院分区：
文献类型：
--
作者：
Zhang Z;Du J;Liu T;Wang F;Jia J;Dong L;Zhao L;Xue Y;Jiang G;Yu X;Huang H
迫切需要更敏感、更快速、更负担得起的肺结核诊断工具。本研究旨在评估EasyNAT MTC(缩写：EasyNAT)(Ustar BioTechnologies，中国)的性能，这是一种新的等温扩增方法，周转时间不到两个小时，需要几个手动步骤来处理痰。对249例疑似肺结核患者的痰标本进行涂片、培养、Xpert MTB/RIF(Cepheid，美国)和EasyNAT检测。在169例肺结核患者中，EasyNAT比Xpert检出更多的肺结核患者(72.19%vs.61.54%，P <； 0.05，χ2 = 4.326)。Xpert法和EasyNAT法均能成功检出几乎所有培养阳性的痰标本，但EasyNAT法在涂片阴性和培养阴性的肺结核患者中的阳性率更高(44.59%(33/74)vs.22.97%(17/74)，P <； 0.01，χ2 = 7.732)。尽管EasyNAT的特异性低于Xpert[95.00%(76/80)vs.98.75%(79/80)]，但差异无统计学意义(P = 0.363，χ2 = 0.826)。EasyNAT具有操作简单、起效快、灵敏度高、成本低等优点，可作为初筛试验用于肺结核的诊断。
More sensitive, rapid, and affordable diagnostic tools for pulmonary tuberculosis (PTB) are urgently needed. This study aimed to assess the performance of EasyNAT MTC (abbreviation: EasyNAT) (Ustar Biotechnologies, China), a novel isothermal amplification method with a turnaround time of less than two hours that requires a few manual steps to process the sputum. Sputum samples from 249 patients with suspected PTB were subjected to smear, culture, Xpert MTB/RIF (Cepheid, USA) and EasyNAT assay testing. Of the 169 PTB patients, EasyNAT detected more PTB patients than Xpert (72.19% vs. 61.54%, P < 0.05, χ2 = 4.326). Both the Xpert assay and EasyNAT assay detected almost all the culture-positive sputa successfully, but EasyNAT yielded more positive results among the smear-negative and culture-negative PTB cases (44.59% (33/74) vs. 22.97% (17/74), P < 0.01, χ2 = 7.732). Although the specificity of EasyNAT was lower in contrast to Xpert [95.00% (76/80) vs. 98.75% (79/80)], the difference was not significant (P = 0.363, χ2 = 0.826). EasyNAT could be used as an initial test for PTB diagnosis due to its simplicity, rapid turnaround time, high sensitivity, and low cost.
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